FDA Approves Merck’s KEYTRUDA (pembrolizumab) for the Treatment of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) that…

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Mercks anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. This approval is based on data from the Phase 2 KEYNOTE-629 trial, in which KEYTRUDA demonstrated meaningful efficacy and durability of response, with an objective response rate (ORR) of 34% (95% CI, 25-44), including a complete response rate of 4% and a partial response rate of 31%. Among responding patients, 69% had ongoing responses of six months or longer. After a median follow-up time of 9.5 months, the median duration of response (DOR) had not been reached (range, 2.7 to 13.1+ months).

Cutaneous squamous cell carcinoma is the second most common form of skin cancer, said Dr. Jonathan Cheng, vice president, clinical research, Merck Research Laboratories. In KEYNOTE-629, treatment with KEYTRUDA resulted in clinically meaningful and durable responses. Todays approval is great news for patients with cSCC and further demonstrates our commitment to bringing new treatment options to patients with advanced, difficult-to-treat cancers.

Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see Selected Important Safety Information below.

Data Supporting Approval

The efficacy of KEYTRUDA was investigated in patients with recurrent or metastatic cSCC enrolled in KEYNOTE-629 (NCT03284424), a multi-center, multi-cohort, non-randomized, open-label trial. The trial excluded patients with autoimmune disease or a medical condition that required immunosuppression. The major efficacy outcome measures were ORR and DOR as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ.

Among the 105 patients treated, 87% received one or more prior lines of therapy and 74% received prior radiation therapy. Forty-five percent of patients had locally recurrent only cSCC, 24% had metastatic only cSCC and 31% had both locally recurrent and metastatic cSCC. The study population characteristics were: median age of 72 years (range, 29 to 95); 71% age 65 or older; 76% male; 71% White; 25% race unknown; 34% Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 and 66% ECOG PS of 1.

KEYTRUDA demonstrated an ORR of 34% (95% CI, 25-44) with a complete response rate of 4% and a partial response rate of 31%. Among the 36 responding patients, 69% had ongoing responses of six months or longer. After a median follow-up time of 9.5 months, the median DOR had not been reached (range, 2.7 to 13.1+ months).

Patients received KEYTRUDA 200 mg intravenously every three weeks until documented disease progression, unacceptable toxicity or a maximum of 24 months. Patients with initial radiographic disease progression could receive additional doses of KEYTRUDA during confirmation of progression unless disease progression was symptomatic, rapidly progressive, required urgent intervention, or occurred with a decline in performance status. Assessment of tumor status was performed every six weeks during the first year and every nine weeks during the second year.

Among the 105 patients with cSCC enrolled in KEYNOTE-629, the median duration of exposure to KEYTRUDA was 5.8 months (range, 1 day to 16.1 months). Patients with autoimmune disease or a medical condition that required systemic corticosteroids or other immunosuppressive medications were ineligible. Adverse reactions occurring in patients with cSCC were similar to those occurring in 2,799 patients with melanoma or non-small cell lung cancer (NSCLC) treated with KEYTRUDA as a single agent. Laboratory abnormalities (Grades 3-4) that occurred at a higher incidence included lymphopenia (11%).

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those 1% included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

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FDA Approves Merck's KEYTRUDA (pembrolizumab) for the Treatment of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) that...

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NOTE: This report takes into account the current and future impacts of COVID-19 on this industry and offers you an in-dept analysis of Cell Expansion Supporting Equipment market.

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Key Players Analysis:

The report analyzes the top manufacturers, exporters, and retailers (if applicable) around the world concerning their company profile, product portfolio, capacity, price, cost, and revenue. For competitor segment, the report covers the following global Cell Expansion Supporting Equipment market key players and some other small players: Beckman Coulter, Inc. (U.S.), STEMCELL Technologies, Inc. (Canada), GE Healthcare (U.K.), Becton, Dickinson and Company (U.S.), Miltenyi Biotec (Germany), Corning, Inc. (U.S.), Thermo Fisher Scientific, Inc. (U.S.), Merck KGaA (Germany), Lonza (Switzerland), Terumo BCT, Inc. (U.S.)

In market segmentation by types, the report covers: Flow cytometer, Cell counters, Centrifuges, Others,

In market segmentation by applications, the report covers the following uses: Regenerative Medicine and Stem Cell Research, Cancer and Cell-based Research, Others,

Regionally, this report focuses on several key regions: North America (United States, Canada and Mexico), Europe (Germany, France, UK, Russia and Italy), Asia-Pacific (China, Japan, Korea, India, Southeast Asia and Australia), South America (Brazil, Argentina, Colombia), Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

Moreover, the report exhaustively investigates business opportunities, market scope, threats, and barriers. The report aims to help companies in strategizing their decisions in a better way and finally attains their business goals. The research answers important business questions like how the global Cell Expansion Supporting Equipment market will perform in the existing market scenario. It also presents the potential industry supply, market demand, market value, market competition, key market players, and the industry estimate from 2020-2025.

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Global Cell Expansion Supporting Equipment Market Research with COVID-19 After Effects - Cole of Duty

Stem Cell And Regenerative Therapy Market : Segmentation, Industry Trends and Development size COVID-19 2024 – 3rd Watch News

he globalstem cell and regenerative medicines marketshould grow from $21.8 billion in 2019 to reach $55.0 billion by 2024 at a compound annual growth rate (CAGR) of 20.4% for the period of 2019-2024.

Report Scope:

The scope of this report is broad and covers various type of product available in the stem cell and regenerative medicines market and potential application sectors across various industries. The current report offers a detailed analysis of the stem cell and regenerative medicines market.

The report highlights the current and future market potential of stem cell and regenerative medicines and provides a detailed analysis of the competitive environment, recent development, merger and acquisition, drivers, restraints, and technology background in the market. The report also covers market projections through 2024.

The report details market shares of stem cell and regenerative medicines based on products, application, and geography. Based on product the market is segmented into therapeutic products, cell banking, tools and reagents. The therapeutics products segments include cell therapy, tissue engineering and gene therapy. By application, the market is segmented into oncology, cardiovascular disorders, dermatology, orthopedic applications, central nervous system disorders, diabetes, others

The market is segmented by geography into the following regions: North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The report presents detailed analyses of major countries such as the U.S., Canada, Mexico, Germany, the U.K. France, Japan, China and India. For market estimates, data is provided for 2018 as the base year, with forecasts for 2019 through 2024. Estimated values are based on product manufacturers total revenues. Projected and forecasted revenue values are in constant U.S. dollars, unadjusted for inflation.

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Report Includes:

28 data tables An overview of global markets for stem cell and regenerative medicines Analyses of global market trends, with data from 2018, estimates for 2019, and projections of compound annual growth rates (CAGRs) through 2024 Details of historic background and description of embryonic and adult stem cells Information on stem cell banking and stem cell research A look at the growing research & development activities in regenerative medicine Coverage of ethical issues in stem cell research & regulatory constraints on biopharmaceuticals Comprehensive company profiles of key players in the market, including Aldagen Inc., Caladrius Biosciences Inc., Daiichi Sankyo Co. Ltd., Gamida Cell Ltd. and Novartis AG

Summary

The global market for stem cell and regenerative medicines was valued at REDACTED billion in 2018. The market is expected to grow at a compound annual growth rate (CAGR) of REDACTED to reach approximately REDACTED billion by 2024. Growth of the global market is attributed to the factors such as growingprevalence of cancer, technological advancement in product, growing adoption of novel therapeuticssuch as cell therapy, gene therapy in treatment of chronic diseases and increasing investment fromprivate players in cell-based therapies.

In the global market, North America held the highest market share in 2018. The Asia-Pacific region is anticipated to grow at the highest CAGR during the forecast period. The growing government funding for regenerative medicines in research institutes along with the growing number of clinical trials based on cell-based therapy and investment in R&D activities is expected to supplement the growth of the stem cell and regenerative market in Asia-Pacific region during the forecast period.

Reasons for Doing This Study

Global stem cell and regenerative medicines market comprises of various products for novel therapeutics that are adopted across various applications. New advancement and product launches have influenced the stem cell and regenerative medicines market and it is expected to grow in the near future. The biopharmaceutical companies are investing significantly in cell-based therapeutics. The government organizations are funding research and development activities related to stem cell research. These factors are impacting the stem cell and regenerative medicines market positively and augmenting the demand of stem cell and regenerative therapy among different application segments. The market is impacted through adoption of stem cell therapy. The key players in the market are investing in development of innovative products. The stem cell therapy market is likely to grow during the forecast period owing to growing investment from private companies, increasing in regulatory approval of stem cell-based therapeutics for treatment of chronic diseases and growth in commercial applications of regenerative medicine.

Products based on stem cells do not yet form an established market, but unlike some other potential applications of bioscience, stem cell technology has already produced many significant products in important therapeutic areas. The potential scope of the stem cell market is now becoming clear, and it is appropriate to review the technology, see its current practical applications, evaluate the participating companies and look to its future.

The report provides the reader with a background on stem cell and regenerative therapy, analyzes the current factors influencing the market, provides decision-makers the tools that inform decisions about expansion and penetration in this market.

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Stem Cell And Regenerative Therapy Market : Segmentation, Industry Trends and Development size COVID-19 2024 - 3rd Watch News

Animal Stem Cell Therapy Market Size Estimation, Industry Demand, Growth Trend, Chain Structure, Supply and Demand Forecast (2020-2027) – Morning Tick

The report on the Animal Stem Cell Therapy market gives an in-depth statistical analysis to examine the fastest growing sectors in the market while speculating the demand and supply, consumption power, spending capacity and distribution channel globally. The report identifies the overall growth in the import and export and derives the future trends that the industry might witness. The study also applies primary and secondary research methods to assess the annual and financial performance of the top vendors and insights from market leaders. The researcher also discusses the recent trends and developments including joint ventures, collaborations, investments, product launches and acquisitions and mergers constitute a substantial part of the research on the Animal Stem Cell Therapy market for the forecast period from 2020 to 2027. The report will empower companies to understand the opportunities, adapt to their consumer demands, needs, and concentrate on their best end-users.

This is the most recent report inclusive of the COVID-19 effects on the functioning of the market. It is well known that some changes, for the worse, were administered by the pandemic on all industries. The current scenario of the business sector and pandemics impact on the past and future of the industry are covered in this report.

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This report focuses on the global top players, covered

VETSTEM BIOPHARMA MediVet Biologic J-ARM Celavet Magellan Stem Cells U.S. Stem Cell Cells Power Japan ANIMAL CELL THERAPIES Animal Care Stem Cell Therapy Sciences VetCell Therapeutics Animacel Aratana Therapeutics

Apart from the above mentioned content the researchers go an extra mile to define the distinct usage occasions and lists the customer segments to leverage the brand and identify future opportunities. Besides, the subject matter expert segment the target customers purely based on their consumption patterns.

Animal Stem Cell Therapy Market split by Type, can be divided into:

Dogs Horses Others

Animal Stem Cell Therapy Market split by Application, can be divided into:

Veterinary Hospitals Research Organizations

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Scope of the report

The study draws a forecast of the growth of the Animal Stem Cell Therapy market by evaluating the market size, share, demand, trends, and gross revenue of the industry. It also focuses on the positions of the major companies against the competitive landscape and their individual share in the global market. The report segments the industry based on product type, application and end-use. It highlights the recent trends and technological developments in the sector that will potentially influence the industry. The research offers a detailed outlook of the trends observed in the market, the contributing factors, major stakeholders, key companies and prime areas that exhibit a potential for growth.

Helping you establish a strong foothold in the industry

The Animal Stem Cell Therapy report highlights set of information related to pricing and the category of customers who are more than willing to pay for certain products and services. The information on opportunities as well as product features, determine which offerings or benefits command sale and identify the communications channels used by the market leaders to create premium positioning strategies as well as attract broadest share.

Market Segment by Regions, regional analysis covers

North America (United States, Canada and Mexico)

Europe (Germany, France, UK, Russia and Italy)

Asia-Pacific (China, Japan, Korea, India and Southeast Asia)

South America (Brazil, Argentina, Colombia)

Study aims at providing data about key category dynamics such as user awareness and a buyers purchase intent, as well as tries to list down the relative influence of certain trends on the demand for a certain product or service.

If you are a Animal Stem Cell Therapy vendor than this article will help you understand the Sales Volume with Impacting Trends. Click To get FREE SAMPLE PDF (Including Full TOC, Table & Figures) @ https://www.marketographics.com/sample-enquiry-form/4606

The study objectives of this report are:

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To summarize, the global Animal Stem Cell Therapy market report studies the contemporary market to forecast the growth prospects, challenges, opportunities, risks, threats, and the trends observed in the market that can either propel or curtail the growth rate of the industry. The market factors impacting the global sector also include provincial trade policies, international trade disputes, entry barriers, and other regulatory restrictions.

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Animal Stem Cell Therapy Market Size Estimation, Industry Demand, Growth Trend, Chain Structure, Supply and Demand Forecast (2020-2027) - Morning Tick

Sussex eye surgeon’s guide to glaucoma, the leading cause of irreversible blindness in the UK – Bognor Regis Observer

Glaucoma is a condition where the optic nerve that carries visual information from the back of the eye to the brain is damaged. The most common cause of glaucoma is high pressure inside the eye.

Director of Innovation Eye Clinic and Head of Glaucoma at Queen Victoria Hospital, East Grinstead, Mr Gok Ratnarajan

Glaucoma is the leading cause of irreversible blindness in the UK and worldwide. Around half-a-million people in the UK are currently diagnosed with glaucoma. Probably about that same number have glaucoma but do not know they have the condition because of the lack of symptoms.

Glaucoma often does not have any symptoms until the disease is already quite advanced. For this reason, glaucoma is sometimes known as the silent thief of sight. The peripheral field of vision is often affected first which can be hard to detect without an eye examination. Rarely, the pressure inside the eye can build up very quickly (called an acute attack of glaucoma), this can cause severe pain. If this occurs you should get your eyes examined immediately.

Glaucoma can be diagnosed after having a full eye examination where the eye pressure, optic nerve and field of vision are assessed. This can be performed by an optician, who will then refer you to an eye doctor (ophthalmologist) if something suspicious is picked up on the eye examination. Glaucoma is more common as you get older and can run in families. If you are over 60, or have a close family member with glaucoma and you are over 40 you should get your eyes tested with your optician every year, and this is covered by the NHS.

As glaucoma cannot currently be cured, the key is early diagnosis. For many decades the main treatment for glaucoma was eye drops. In more recent years with the advent of new lasers and minimally invasive glaucoma surgery (MIGS) we now have many more treatment options available.

Any new developments or treatments in glaucoma?

Yes, indeed. New glaucoma lasers and safer, less invasive operations are now available which can often prevent glaucoma getting worse, and results in less patients needing lifelong eye drops. Innovations and advancements in glaucoma treatment is my passion and where a lot of my clinical research is focused. It is really quite exciting to be able to offer safer and more effective treatments. Progress is also being made to further understand the genetics of glaucoma. This may mean we can identify those most at risk of glaucoma even before damage to the optic nerve has occurred. The holy grail is to repair an optic nerve that is already damaged from glaucoma. Although promising stem cell research is underway, no cure for glaucoma is available at present.

Glaucoma Awarenerss Week 2020 runs from June 29 until July 5.

Mr Ratnarajan said: Glaucoma is a serious condition that can lead to irreversible sight loss. Early diagnosis is the key to protecting your eyesight. Raise awareness of glaucoma by sharing this article with friends and family members, and most importantly get your eyes tested regularly.

More information on glaucoma can be found at http://www.innovationeyeclinic.co.uk/glaucomaUntil end of September, Mr Gok Ratnarajan is offering a 150 discount to any reader of this newspaper who wishes to have a consultation. His office can be contacted on 07495522011 or info@innovationeyeclinic.co.uk

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Sussex eye surgeon's guide to glaucoma, the leading cause of irreversible blindness in the UK - Bognor Regis Observer

Stem Cell Research: Beyond Federal Restrictions …

From the contentious debate over federal funding for stem cell research, it would be easy to assume that if restrictions were lifted, research would blossom and miraculous therapies would spring up like mushrooms after a downpour. Those who have been following the controversy over federal subsidies know that even if funds were unrestricted, investigators would still have to clear several significant hurdles before treatments derived from human embryonic stem cells (hESCs) could become a reality.

DIFFERENTIATION

Pluripotentiality, the cells' greatest asset, also presents their most basic challenge: directing and controlling their differentiation into a specific cell type, generation after generation, in a consistent and predictable fashion. "Our ability to extract the cell type of interest is still in its infancy," says Douglas Kerr, MD, PhD, associate professor of neurology at Johns Hopkins University, Baltimore.

Currently, there are at least 2 ways of accomplishing this, explains Kerr. The first is to bathe the undifferentiated cells in a cocktail of growth factors, with recipes varying according to the desired cell type. Kerr and his colleagues used this technique to generate motor neurons from mouse embryonic stem cells, which they implanted into partially paralyzed rats. By suppressing the normal axon-inhibiting properties of myelin and administering glial-cell derived neurotrophic factor into the sciatic nerve, they were able to coax the stem cell-derived neurons to form synapses with the gastrocnemius muscle and achieve a 50% improvement in hind limb grip strength after 4 months.1

This approach does not work with all cells, including dopaminergic neurons, Kerr points out. The second method is to use transcription factors to overexpress a certain cell type, followed by sorting techniques to choose the cells when they start to express a certain phenotype.

Even then, successful differentiation in the limited quantities adequate for basic research is no guarantee that the same method will work in the long term on the commercial scale required for creating a viable human therapy. "You must be able to direct differentiation to one cell type day in and day out, and I don't think most groups have come to grips with that," says Steven Minger, PhD, director of the Stem Cell Biology Laboratory at the Wolfson Centre for Age-Related Diseases at King's College, London, and leader of the first group to develop an hESC line in the United Kingdom. The ability to proliferate over time with no loss of pluripotency or multipotency is one of the minimal requirements for a successful stem cell line, he explains.

TRANSPLANTED CELLS

The fate of the cells once they are transplanted presents another hurdle. "Would the cells survive and multiply and do what you want them to do after they are injected?" asks Thomas Swift, MD, professor emeritus and former chair of neurology at the Medical College of Georgia, Savannah, and president of the American Academy of Neurology (AAN).

The brain is a complicated organ: connections are continually being formed and cells are sprouting and dying. Some neurons in the brain have processes that are a foot long and extend into the spinal cord, Swift explains. Merely injecting stem cells into the brain is no guarantee that they will behave as desired. "You must reestablish the connections and re-create the anatomy. The single biggest question is: are these cells going to be able to reconstruct the anatomy necessary to restore function?"

"You cannot put a new cell into a brain that's been making synaptic connections for 30, 40, or 50 years," adds David Hess, MD, professor and current chair of neurology at the Medical College of Georgia. His own research involves implantation of adult stem cells that secrete factors that promote the growth and development of endogenous neurons and supporting blood vessels.

The potential for adverse effects is another issue that concerns stem cell researchers. An undifferentiated cell injected by mistake could give rise to a teratoma. Immune rejection is also a possibility. There is evidence that hESCs have an "immune-privileged" status, so they fail to elicit much of an immune response, at least in animals.2,3 But research in this area is still in an early phase, and more studies are needed to confirm these findings.

COMMERCIAL PRODUCTION: COMING SOON?

Even after the basic science is figured out, the challenge of churning out cells in the quantities required to make them commercially viable is formidable. At a stem cell conference in London last summer, Minger used the example of pancreatic islet cells for treating diabetes. The average pancreas has a million islets, each of which contains about 5000 cells, so one pa-tient would need approximately 5 billion cells. Multiply that by the millions of diabetic persons worldwide, and the scope of the problem becomes apparent.

One of the issues stem cell researchers are grappling with is the problem of developing suitable culture media. "Right now, very few lines are suitable for human use, because they are derived from systems that have used animal cells and other products. These may contain viruses or other pathogens that may elicit an immune response," Minger explains.

"Any treatment must be commercializable for use in patients," Hess points out. "Human embryonic stem cells are hard to expand and scale up in number without using animal proteins."

At least one company, Geron Corporation of Menlo Park, California, claims that it has developed proprietary methods for the growth, maintenance, and scale-up production of undifferentiated hESCs in culture media that are free of feeder cells, which would reduce concerns over immune rejection. Speaking at the same London conference at which Minger appeared, Thomas Okarma, MD, Geron's chief executive officer, reported that his company has developed scalable manufacturing procedures to differentiate hESCs to therapeutically relevant cell types. "We are now testing 6 different therapeutic cell types in animal models," he said. "In 5 of these cell types, we have preliminary results suggesting efficacy as evidenced by durable engraftment or improvement of organ function in the treated animals."4

The first hESC-derived cells Geron plans to test in humans come from a line of oligodendroglial progenitor cells developed to repair spinal cord injuries. In animal studies, "the cells behaved as if they were making a spinal cord for the first time," Okarma said at the conference. He predicted that clinical trials would begin in the first quarter of 2007.

Kerr, who has participated in some of the Geron research, says that 2008 or 2009 may be a more realistic projection.

Minger, however, believes it will be at least 7 to 15 years before hESC products are ready for commercial use in humans. "We have to learn how to transplant the cells and how much dopamine or insulin or other factors we are going to need. Our major problem is, can we make the cells?" He terms predictions that treatments could appear within 2 to 3 years as "grossly irresponsible," and adds, "when I'm ready to transplant these cells into my mother, that's when we'll be ready to use them clinically."

Sharing this view is the California Institute for Regenerative Medicine (CIRM), the body created in 2004 after the passage of Proposition 71, which approved $3 billion in state funds over 10 years for research on hESCs as a way of getting around federal funding restrictions. On October 4, CIRM stated in its newly released scientific strategic plan that it intends to help bring several promising therapies to clinical trials within the next decade, but that stem cell therapies for routine use were unlikely to appear before then.5

PATENT PROBLEMS

Yet another challenge to the widespread use of hESCs in the United States comes not from a scientific source but a legal one. In fact, some observers believe it has dampened hESC research in the United States as much as federal policy.

In 1994, Ariff Bongso, PhD, an embryologist at the University of Singapore, became the first person to successfully isolate hESCs from 5-day-old human blastocysts. He followed that up in 2002 by developing a method for culturing the cells in media free of animal products, thus clearing one of the most significant hurdles to clinical research.

While Bongso showed that hESCs could be isolated, he was unable to maintain a viable cell line. That was achieved in 1998 by James Thomson, PhD, a veterinarian and developmental biologist at the University of Wisconsin, Madison. The United States Patent and Trademark Office awarded Thomson 3 patents based on his research, but as a University of Wisconsin employee, he turned them over to the Wisconsin Alumni Research Foundation (WARF), a nonprofit group established in the 1920s to handle the school's intellectual property revenues.

Essentially, the patents give WARF the rights to all hESCs developed in the United States. Through them, the foundation claims the right to demand fees, royalties, and annual payments from commercial users of hESCs--not only from the lines developed at the University of Wisconsin but from virtually every hESC line available. WARF imposes fees ranging from $75,000 to $400,000, depending on a company's size and the terms of its license. Currently, Geron holds the exclusive commercial rights from WARF to nerve, heart, and pancreatic cells derived from hESCs.

"We would argue that WARF's position has driven scientists out of the United States as much as the federal funding issues," says John Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, a California consumer rights group. "It has a chilling effect on the exchange of scientific ideas, and it interferes with smaller companies being able to get venture capital funding for their research," he tells Applied Neurology.

The WARF patents could also prevent the public from benefiting from research that it has subsidized. For example, CIRM executives have stated they would like to receive royalties on research funded by the institute as a way of giving taxpayers a return on their dollars, but much of those funds would be wiped out if WARF insists on receiving its share. The Juvenile Diabetes Foundation has begun awarding grants to stem cell researchers in other countries, claiming it finds WARF's demands too onerous.6

Last July, Simpson's organization, along with the Public Patent Foundation, requested a formal review of WARF's stem cell patents on the grounds that the patents inhibit scientific enquiry. They argue that Thomson just took technology that had been described for isolating animal stem cells as early as 1983 and applied it to human cells. "Patenting embryonic stem cells is like patenting food just because you can cook," Simpson wrote in a commentary.6 In October, the patent office agreed to conduct a review of the patents' validity. A final decision could take several years.

ALTERNATIVES

Given the political, logistic, and financial impediments to hESC research, many investigators are trying to obtain the information they seek in other ways. Adult stem cells are seen as an alternative. Hess, for one, believes that many investigators underestimate their potential. In his research, models of animal stroke experienced at least a 25% functional improvement following the transplantation of 200,000 to 400,000 multipotent adult progenitor cells derived from bone marrow. Fewer than 1% of the transplanted cells were present in the animals 2 months later, but there was evidence that the rats had developed new neurons, apparently from endogenous stem cells. "There are ways around using embryonic stem cells, and if we took that route we'd be much further ahead than we are now," Hess maintains.

Other experts aren't so sure. "Adult stem cells are a powerful source, but they are not the blank slate mother-of-all-cells that embryonic stem cells are," says Kerr. "You can reprogram to a different fate, but it's very hard. We've tried."

A position statement on the use of stem cells in biomedical research published jointly by the AAN and the American Neurological Association states that "the potential for translating adult stem cell research into therapy is far more uncertain" than that of embryonic stem cells.7 "We don't know the potential of other types of stem cells, like hematopoietic or other adult cells," says Swift, one of the statement's coauthors. "They may have a very wide potential to do all kinds of things, even if it's not as much as embryonic stem cells."

Hess, however, believes that some investigators' political or ethical beliefs may be giving them tunnel vision. "There are alternatives to all of this," he says. "The question is, do we want to look for them?"

REFERENCES1. Deshpande DM, Kim YS, Martinez T, et al. Recovery from paralysis in adult rats using embryonic stem cells. Ann Neurol. 2006;60:32-44. 2. Li L, Baroja ML, Majumdar A, et al. Human embryonic stem cells possess immune-privileged properties. Stem Cells. 2004;22:448-456. 3. Drukker M, Katchman H, Katz G, et al. Human embryonic stem cells and their differentiated derivatives are less susceptible to immune rejection than adult cells. Stem Cells. 2005;24:221-229. 4. Okarma T. Taking hESC-based products into the clinic. Lecture presented at: European Stem Cells & Regenerative Medicine Congress; June 7, 2006; London. 5. Foundation for Taxpayer and Consumer Rights. Stem cell institute plan shows refreshing candor consumer advocates say. Press release. October 4, 2006. 6. Simpson JM. The missing link in stem-cell research. Sacramento Bee. July 2, 2006. 7. American Academy of Neurology and the American Neurological Association. Position statement regarding the use of embryonic and adult human stem cells in biomedical research. Neurology. 2005;64:1679-1680.

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Stem Cell Research: Beyond Federal Restrictions ...

Cell Proliferation Kit Product Witness (es) Dampening Sales as ABC End-use Industry Suffers Massive Blow Due to COVID-19 Pandemic – Medic Insider

Analysis of the Global Cell Proliferation Kit Market

The report on the global Cell Proliferation Kit market reveals that the market is expected to grow at a CAGR of ~XX% during the considered forecast period (2019-2029) and estimated to reach a value of ~US$XX by the end of 2029. The latest report is a valuable tool for stakeholders, established market players, emerging players, and other entities to devise effective strategies to combat the impact of COVID-19

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Regional Landscape

The regional landscape section provides a deep understanding of the regulatory framework, current market trends, opportunities, and challenges faced by market players in each regional market. The various regions covered in the report include:

End-User Assessment

The report bifurcates the Cell Proliferation Kit market based on different end users. The supply-demand ratio and consumption volume of each end-user is accurately depicted in the report.

The following manufacturers are covered: Biological Industries Thermo Fisher Scientific Sigma-Aldrich (Merck) BD Biosciences GE Healthcare PerkinElmer Millipoore (Merck) Bio-Rad Biotium Mindray Medical

Segment by Regions North America Europe China Japan

Segment by Type Colorimetric Detection Method Fluorescent Detection Method Other

Segment by Application Clinical Industrial & Applied Science Stem Cell Research

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Essential Findings of the Cell Proliferation Kit Market Report:

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Cell Proliferation Kit Product Witness (es) Dampening Sales as ABC End-use Industry Suffers Massive Blow Due to COVID-19 Pandemic - Medic Insider

Global Stem Cell Drugs Market Research with COVID-19 Impact Analysis and Competitive Outlook 2020-2025 – Cole of Duty

Global Stem Cell Drugs Market 2020 by Manufacturers, Regions, Type and Application, Forecast to 2025 displays the market, size, key aspects, and revenue forecast of the industry for 2020 to 2025. The report provides exhaustive data on present and estimate industry status as well as the dependable measurements by fragmenting the global Stem Cell Drugs industry dependent on the item type, applications, and regional presence. The report gives detailed insight, industry knowledge, and key market players. The report offers market analysis from 2015 2020 and the forecast information up to 2025. The research provides a thorough understanding of market capacities in a real-time scenario.

The report covers key market players shares, growth rates, and market appeal in various regions/end users. It emphasizes the key driving and restraining forces for this market and presents a complete study of the future trends and developments of the global Stem Cell Drugs market. The global market report has been segmented on the basis of product type, sales channel, and region. It demonstrates a host of company profiles covering their market size, key product launches, information regarding the strategies they employ, and others. It also identifies the total market sales generated by a particular firm over a period of time.

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NOTE: Our report highlights the major issues and hazards that companies might come across due to the unprecedented outbreak of COVID-19.

Report Aims:

This report aims to present an industry overview, market development scenario, segmentation analysis, and price structures. It aims to find out the sales, value, and status of the global Stem Cell Drugs market at both local and global levels. It also wants to help market players in executing strategies based on market needs. It clarifies the assembling procedure examination, utilization, supply and demand, and cost structures.

Based on regions, the market is classified into: North America (United States, Canada and Mexico), Europe (Germany, France, UK, Russia and Italy), Asia-Pacific (China, Japan, Korea, India and Southeast Asia), South America (Brazil, Argentina, etc.), Middle East& Africa (Saudi Arabia, Egypt, Nigeria and South Africa)

The below some important organization as the main competitor in the global Stem Cell Drugs market research report are: JCR Pharmaceuticals Co., Ltd, MEDIPOST, Anterogen, CORESTEM, Inc, New York Blood Center, Pharmicell Co., Ltd, Takeda, Chiesi Pharmaceuticals

Split by product type, with production, revenue, price, market share and growth rate of each type, can be divided into: Cord Blood-Derived, Adipose-Derived, Bone Marrow-Derived, Others, etc.,

Split by application, this report focuses on consumption, market share, and growth rate in each application and can be divided into: Acute Graft-versus-Host Disease, Crohns Disease, Amyotrophic Lateral Sclerosis, Osteoarthritis, Others

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Moreover, the report consists of reliable data on the investment opportunities, market dynamics, competition analysis, major market players, basic industry facts, important figures, prices, sales, revenues, gross margins, market shares, key business strategies, and top regions. Notable business events studied in the report include corporate deals, mergers and acquisitions, joint ventures, partnerships, product launches, and brand promotions. This report will help the readers decipher the current and future constraints in the global Stem Cell Drugs market.

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Excerpt from:
Global Stem Cell Drugs Market Research with COVID-19 Impact Analysis and Competitive Outlook 2020-2025 - Cole of Duty

In Bengaluru, a constellation if institutions – The Hindu

A fortuitous set of historical circumstances in Bengaluru has created a unique scientific and technological ecosystem. The nucleation of scientific research institutions in the city began with the founding of the Indian Institute of Science (IISc.) in 1909. It was a unique collaboration of private philanthropy [Jamsetji Nusserwanji Tata and the Nizam of Hyderabad] and support from the then Mysore Maharaja, together with advice from Nobel Laureate William Ramsey.

With a strong scientific leadership, like that of C.V. Raman and J. C. Ghosh, the institute steadily grew and nurtured a number of future science leaders of independent India, such as Homi J. Bhabha [who established cosmic ray research here and proceeded to build the Tata Institute of Fundamental Research]; Vikram Sarabhai [founder of the Indian Space Research Organisation], and Satish Dhawan [who played a major role at the National Aeronautical Laboratory and also headed ISRO], to name a few. IISc. also nurtured scientific stalwarts like Harish-Chandra and G. N. Ramachandran.

The countrys foremost referral centre for matters of the brain, the National Institute for Mental Health and Neurosciences (NIMHANS), has an equally long history.

The Bangalore Lunatic Asylum, founded in 1847 and rechristened as the Mysore Government Mental Hospital in 1925, became the first institute in India for postgraduate training in psychiatry. NIMHANS was born from the amalgamation of the mental hospital and the All-India Institute of Mental Health (AIIMH), established by the Union government in 1954.

Laboratories of the Defence Research and Development Organisation, and the Council of Scientific and Industrial Research are more recent entrants. The National Aeronautical Research Laboratory (NARL), set up at the stables of the palace of Maharaja of Mysore in Bengaluru, was converted into the National Aeronautical Laboratory under CSIR in 1960. It was further renamed the National Aerospace Laboratories (NAL) in 1993 to reflect its growing involvement in the Indian space programme.

Today, the list of research institutions in Bengaluru has grown to include the Raman Research Institute, the Indian Institute of Astrophysics, the Indian Statistical Institute, the Jawaharlal Nehru Centre for Advanced Scientific Research, three centres of TIFR (NCBS, CAM and ICTS), and more recently, the Institute for Stem Cell and Regenerative Medicine, to name just a few, all funded by various Union and State Science and Human Resource Departments.

Additionally, the presence of premier institutions in other professional disciplines, such as the National Law School of India University and the IIMB, have given Bengaluru a more rounded academic atmosphere. However, with the exception of the Institute for Social and Economic Change and the Indian Institute for Human Settlements, notably absent are long-lived institutions focused on Humanities.

Research centres like those above cannot thrive without having a feeder from undergraduate colleges.

Here again, Bengaluru, and for that matter Karnataka, has pioneered some fine undergraduate institutions and universities.

From public universities, such as the University Of Mysore and the Bangalore University, to private institutions, such as Manipal Academy of Higher Education, CHRIST (Deemed to be University) and more recently the Azim Premji University, the State has also promoted higher educational institutions.

Again, strong institutions from pre-Independence, like Science College (which later came under the Bangalore University), the 150-year-old Bangalore High School that gave rise to Central College, and the University Visvesvaraya College of Engineering (UVCE), set up by Sir M. Visvesvaraya, and Manipal University produced some accomplished students, who went on to shine in science and engineering at the international stage. IISc.s undergraduate programme in the sciences since 2009 has added a new dimension.

This constellation of institutions has created a name for Bengaluru as Indias science capital and renown on the international science scene as the home of a number of pioneering scientific ideas, discoveries and experiments.

A key ingredient in this success was political will. In the post-Independence era, strong political support for science and technology was crucial. Given the poverty and a low growth economy, such support was considered a wasteful expenditure by many. Bengaluru truly embraced the Nehruvian outlook of a self-reliant India, led by science.

This resulted in world-class institutions of excellence with support from both government and far-sighted philanthropists.

The strong scientific presence has also been a backbone for technological development. In the last 50 years, this ecosystem served the public sector with giants such as ITI, HMT, Bharat Electronics Limited (BEL), Bharat Heavy Electricals Limited (BHEL), and the aerospace industry, through the presence of ISRO as well as NAL and Hindustan Aeronautics Limited (HAL), reaping benefits of this human capital.

Since the late 1980s, private home-grown infotech and biotech industries [such as Infosys, Wipro, Biocon] and start-ups have also made Bengaluru their home, powered by the S&T institutions that produced highly skilled scientific and technical manpower.

Many international corporations have also set up R&D divisions here in the last couple of decades for the same reason. The State government has always been very forward in driving this synergy with the establishment of many Vision Groups in Information Technology, biotechnology, nanoscience, providing the necessary interface between the academic, industrial and government milieu.

Today, Bengaluru is also home to Indias most vibrant biotech start-up ecosystem, with State-supported Bangalore Bio Cluster, and the Bangalore Life Science Clusters Centre for Cell and Molecular Platforms (C-CAMP) as key players.

The city is perhaps unique in India to have created this ecosystem of institutions of scientific and technological excellence, which have had a broader impact on industry and society.

Worldwide, such concentrations of knowledge have driven wealth creation. Prominent examples are the Bay Area and Boston area in the U.S., and Cambridge in the U.K.

The question we need to be asking ourselves in 2020 is: given all the ingredients that Bengaluru has, where can we now take this? In the next 50 years, will it grow to be a global nervecentre for breakthroughs in STEM, which can hope to rival San Francisco or Boston? And if so, what is the pathway to getting there in the coming 50 years? Will this be sustainable? Are there new avenues for such an ecosystem to turn its focus to?

We feel Bengaluru can be a world science hub, given sustained efforts by all stakeholders. However, given the collaborative and transdisciplinary nature of contemporary science, our strategy should shift to coordinated engagement across institutions. Here, the recent announcement, by the Centre, of supporting geographical clusters takes significance.

If this coordination can take place, Bengaluru can mobilise its unique experience and chart out a brilliant future. Bengaluru is also home to a large number of NGOs working on environmental sustainability. Here too, new synergies are emerging: problems and solutions of sustainability require the coordination of many knowledge sources.

Bengaluru is also home to one of Indias fastest growing healthcare sectors.

There is a huge knowledge base in agriculture, with one of Indias best universities in this sector and many institutions that serve this critical sector. The gaze of Bengalurus multi-disciplinary scientific capital should look at these new opportunities, so that in the next few decades Karnataka will also be known for a transformative innovation in healthcare and agriculture as well as in environmental sustainability. Along with its core strengths in the basic sciences today, which must be deepened further, this can be an unbeatable combination.

(Rajesh Gopakumar and Satyajit Mayor are Centre Directors of the International Centre for Theoretical Sciences and the National Centre for Biological Sciences, respectively.)

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In Bengaluru, a constellation if institutions - The Hindu