Category Archives: Stell Cell Research


Stem Cell Therapy: A Ray of Hope to End Global Pandemic of COVID-19 – Communal News

I would never have thought that a mutant flu virus could create that big panic in people at each and every corner of the world. In fact, the past few days in quarantine have really made me realize where exactly humanity is heading. For the majority of us, our lives are on a temporary hold while the world is dealing with the global pandemic of COVID-19.

In fact, the past three months have served as something of inflection for many countries and as the number of infected patients has surpassed onemillion, there is already a sense of worry looming across the industries. Since Coronavirus is a newly identified pathogen, there is no known pre-existing immunity observed in humans and therefore everyone is assumed to be susceptible.

While researchers all across the globe are putting efforts to develop an immediate treatment, there are speculations, based on credible evidence, that infected patients treated with Stem Cell Therapy are more likely tosurvive the disease. Specifically, mesenchymal stem cells can be effectively used to improve patients resistance to the SARS-CoV-2 virus-induced pneumonia as these cells have the potential to repair damaged tissues in the patients respiratory system leading to a speedy recovery.

Recent Trends

Looking at the efforts made by different pharmaceutical companies, I felt assured and hopeful as many patients have successfullyrecovered, while others are on the verge of getting discharged by using these novel classes of regenerative medicines.

What are the Key Hubs for Stem Cell Research?

With the virus strengthening its foothold in several countries across the globe, the threat of pandemic has become real and the question is are we ready?

As per the recent study published byRoots Analysis, the efforts for the development of stem cell therapies have been undertaken by players all across the globe, majority of the developers (45%) are based in Asia-Pacific regions; China, South Korea and Japan; followed by developed countries, such as the US, Germany, Belgium, Spain and the UK.

Roots Analysis, in its recent report, has captured the clinical and research landscape of stem cell therapy-based treatment. To know further, check out the report here.

Expert Opinion

In fact. several industry stakeholders are quite optimistic about the future market potential of stem cell-based therapies.

Bottom Line: Stay Cautious, Stay Hopeful!!

In the midst of the anxiety, worry, and uncertainty surrounding the COVID-19 pandemic, each day seems to bring news thats worse than the day before. However, remember this is not for the first time any pandemic outbreak has taken place in the history of mankind. About 200,000 (~20%) patients have already beenrecoveredfrom this disease. The sky is not falling and for sure, life would return to normal. Stay cautious, stay hopeful.

For further information check out the report here.

Read the original here:
Stem Cell Therapy: A Ray of Hope to End Global Pandemic of COVID-19 - Communal News

US Food and Drug Administration Approves DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a New Subcutaneous Formulation of Daratumumab in the…

HORSHAM, Pa., May 1, 2020 /PRNewswire/ --The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a new subcutaneous formulation of daratumumab. DARZALEX FASPRO is approved in four regimens across five indications in multiple myeloma patients, including newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients.As a fixed-dose formulation, DARZALEX FASPRO can be administered over approximately three to five minutes, significantly less time than DARZALEX,which is given intravenously over hours. In the Phase 3 COLUMBA study supporting the approval, DARZALEX FASPRO demonstrated a consistent overall response rate (ORR) and pharmacokinetics and a similar safety profile compared with intravenous DARZALEX in patients with relapsed or refractory multiple myeloma. In addition, there was a nearly two-thirds reduction in systemic administration-related reactions (ARRs) for DARZALEX FASPRO compared to intravenous DARZALEX (13 percent vs. 34 percent, respectively).

"This approval exemplifies Janssen's mission and commitment to bringing together passion, science and ingenuity to advance novel solutions for patients," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. "We are excited about the potential of this meaningful innovation in transforming the treatment experience for patients with multiple myeloma where DARZALEX FASPRO can be administered in approximately three to five minutes, significantly less time than intravenous DARZALEX, which is given over hours. Based on its favorable profile, we are accelerating the development of DARZALEX FASPRO and evaluating its potential in multiple ongoing studies."

Click to Tweet: #NEWS: #FDA approves subcutaneous CD38-directed antibody for the treatment of multiple #myeloma. See here for more details: https://bit.ly/2VozhzY

The approval is based on data from the Phase 3 COLUMBA (MMY3012)and Phase 2 PLEIADES (MMY2040) studies.1,2 In the COLUMBA study, the ORR was non-inferior for patients taking DARZALEX FASPROas monotherapycompared to those taking intravenous DARZALEXas monotherapy (41 percent vs. 37 percent, respectively). In addition, there were fewer systemic ARRs with DARZALEX FASPRO versus intravenous DARZALEX (13 percent vs. 34 percent, respectively). In a pooled safety population of 490 patients who received DARZALEXFASPRO as monotherapy or in combination, the ARR rate wFas 11 percent. The safety profiles of intravenous DARZALEX and DARZALEX FASPRO were otherwise similar.1 Additionally, in the Phase 2 PLEIADES study evaluating the efficacy and safety of DARZALEX FASPRO in combination therapies, objective responses were demonstrated in combination with bortezomib, melphalan and prednisone (D-VMP) in newly diagnosed transplant ineligible patients. In addition, objective responses were demonstrated in combination with lenalidomide and dexamethasone (D-Rd) in relapsed or refractory patients who received one prior line of therapy.2

"The Multiple Myeloma Research Foundation shares a common goal with Janssen in advancing treatments for multiple myeloma and addressing the unmet needs of this patient community," said Paul Giusti, President and CEO of the Multiple Myeloma Research Foundation (MMRF). "The approval of DARZALEXFASPRO marks an important milestone which will help make a positive difference in the lives of patients who depend on this effective therapy."

Click to Tweet: .@theMMRF talks about advancing treatments for multiple #myeloma and addressing patient needs with latest #FDA approval. Read more here: https://bit.ly/2VozhzY

"Since the approval of daratumumab, a robust body of evidence has established its use as a treatment for multiple myeloma in both the frontline and relapsed and refractory settings," said Saad Z. Usmani, M.D., Division Chief of Plasma Cell Disorders, Levine Cancer Institute. "With DARZALEX FASPRO there may be fewer administration-related reactions compared to intravenous DARZALEX, providing an additional treatment option that may help patients, oncologists and nursing staff."

DARZALEX FASPROis co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) [Halozyme'sENHANZEdrug delivery technology].DARZALEX FASPRO will be available to patients and physicians as soon as the week of May 11, 2020. The intravenous DARZALEX formulation will also remain available as an option for patients and their physicians.

DARZALEX FASPROis approved in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant, in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy, in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy, as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

The U.S. FDA approval of DARZALEX FASPRO marks the first approval for this innovative subcutaneous formulation globally, and Janssen continues to work with health authorities around the world in an effort to bring this new treatment option to patients living with multiple myeloma.

Access to DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)Janssen offers comprehensive access and support information, resources and services to assist U.S. patients in gaining access to DARZALEX FASPROthrough the Janssen CarePath Program. Through the program, eligible commercial patients pay no more than $5 per injection, regardless of individual income level. Information on the enrollment process is available online atwww.CarePathSavingsProgram.com/DARZALEX.

For more information, healthcare providers or patients can contact: 1-844-55DARZA (1-844-553-2792). Information will also be available atwww.DARZALEX.com. Dedicated case coordinators are available to work with both healthcare providers and patients.

About the COLUMBA Study 1The randomized, open-label, multicenter Phase 3 COLUMBA study (MMY3012) included 522 patients (median age of 67 years) with multiple myeloma who had received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease was refractory to both a PI and an IMiD. In the arm that received DARZALEX FASPRO(n=263), patients received a fixed dose of DARZALEX FASPRO1,800 milligrams (mg), co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) 2,000 Units per milliliter (U/mL), subcutaneously weekly for Cycles 1 2, every two weeks for Cycles 3 6 and every four weeks for Cycle 7 and thereafter. In the intravenous DARZALEXarm (n=259), patients received DARZALEXfor intravenous infusion 16 milligrams per kilogram (mg/kg) weekly for Cycles 1 2, every two weeks for Cycles 3 6 and every four weeks for Cycle 7 and thereafter. Each cycle was 28 days. In the arm that received DARZALEX FASPRO, itwas given in a fixed volume of 15 mL over three to five minutes; the median injection time was five minutes. In the arm that received theintravenous administration, the median durations of the first, second and subsequent intravenous DARZALEXinfusions were 7.0, 4.3 and 3.4 hours, respectively.Patients in both arms continued treatment until disease progression or unacceptable toxicity.

About the PLEIADES Study 2The non-randomized, open-label, parallel assignment Phase 2 PLEIADES study (MMY2040) included more than 240 adults with multiple myeloma, including 67 patients with newly diagnosed multiple myeloma who were treated with 1,800 mg of DARZALEX FASPROin combination with bortezomib, melphalan, and prednisone (D-VMP) and 65 patients with relapsed or refractory disease who were treated with 1,800 mg of DARZALEX FASPROplus lenalidomide and dexamethasone (D-Rd). The primary endpoint for the D-VMP and D-Rd cohorts was overall response rate.

About DARZALEXand DARZALEX FASPROJanssen is committed to exploring the potential of DARZALEX (daratumumab) for patients with multiple myeloma across the spectrum of the disease. DARZALEX has been approved in seven indications, three of which are in the frontline setting, including newly diagnosed patients who are transplant eligible and ineligible.

DARZALEX has become a backbone therapy in the treatment of multiple myeloma, having been used in the treatment of more than 58,000 patients in the U.S. alone since its U.S. FDA approval in 2015. DARZALEX is the first CD38-directed antibody approved globally to treat multiple myeloma and in 2020, DARZALEX FASPRO(daratumumab and hyaluronidase human-fihj) follows as the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma.2

CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.4 DARZALEX binds to CD38 and inhibits tumor cell growth causing myeloma cell death.5 DARZALEX may also have an effect on normal cells.3 Data across seven Phase 3 clinical trials, in both the frontline and relapsed settings, have shown that DARZALEX-based regimens resulted in significant improvement in progression-free survival and/or overall survival. 4,5,6,7,8,9,10,11 Additional studies are underway to assess the efficacy and safety of DARZALEXFASPRO in the treatment of other malignant and pre-malignant hematologic diseases in which CD38 is expressed, including smoldering myeloma and in amyloidosis.12,13

Key DARZALEX Milestones:

Please see full Prescribing Information at http://www.DARZALEX.com.

About Multiple MyelomaMultiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.21,22When damaged, these plasma cells rapidly spread and replace normal cells with tumors in the bone marrow. In 2020, it is estimated that 32,270 people will be diagnosed and 12,830 will die from the disease in the U.S.24 While some patients with multiple myeloma have no symptoms, most patients are diagnosed due to symptoms, which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.23

DARZALEX FASPROIMPORTANT SAFETY INFORMATION CONTRAINDICATIONSDARZALEX FASPRO is contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase or any of the components of the formulation.

WARNINGS AND PRECAUTIONS

Hypersensitivity And Other Administration Reactions

Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO.

Systemic Reactions

In a pooled safety population of 490patients who received DARZALEX FASPROas monotherapy or in combination, 11% of patients experienced a systemic administration-related reaction (Grade 2: 3.9%, Grade 3: 1.4%). Systemic administration-related reactions occurred in 10% of patients with the first injection, 0.2% with the second injection, and cumulatively 0.8% with subsequent injections. The median time to onset was 3.7hours (range: 9minutes to 3.5days). Of the 84systemic administration-related reactions that occurred in 52patients, 73(87%) occurred on the day of DARZALEX FASPRO administration. Delayed systemic administration-related reactions have occurred in less than 1% of the patients.

Severe reactions included hypoxia, dyspnea, hypertension and tachycardia. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritis, chills, vomiting, nausea, and hypotension.

Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen and corticosteroids. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) administration-related reactions, immediately and permanently discontinue DARZALEX FASPRO. Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions.

Local Reactions

In this pooled safety population, injection-site reactions occurred in 8% of patients, including Grade2 reactions in 0.6%. The most frequent (>1%) injection-site reaction was injection site erythema. These local reactions occurred a median of 7minutes (range: 0minutes to 4.7days) after starting administration of DARZALEX FASPRO. Monitor for local reactions and consider symptomatic management.

Neutropenia

Daratumumab may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX FASPRO until recovery of neutrophils. In lower body weight patients receiving DARZALEX FASPRO, higher rates of Grade 3-4 neutropenia were observed.

Thrombocytopenia

Daratumumab may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Consider withholding DARZALEX FASPRO until recovery of platelets.

Embryo-Fetal Toxicity

Based on the mechanism of action, DARZALEX FASPRO can cause fetal harm when administered to a pregnant woman. DARZALEX FASPRO may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX FASPRO and for 3months after the last dose.

The combination of DARZALEX FASPRO with lenalidomide is contraindicated in pregnant women, because lenalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide prescribing information on use during pregnancy.

Interference with Serological Testing

Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type are not impacted.

Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX FASPRO. Type and screen patients prior to starting DARZALEX FASPRO.

Interference with Determination of Complete Response

Daratumumab is a human IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some DARZALEX FASPRO -treated patients with IgG kappa myeloma protein.

Adverse Reactions

The most common adverse reaction (20%) with DARZALEX FASPRO monotherapy is: upper respiratory tracts infection.

The most common adverse reactions (20%) with D-VMP are upper respiratory tract infection, constipation, nausea, fatigue, pyrexia, peripheral sensory neuropathy, diarrhea, cough, insomnia, vomiting, and back pain. The most common adverse reactions (20%) with D-Rd are fatigue, diarrhea, upper respiratory tract infection, muscle spasms, constipation, pyrexia, pneumonia and dyspnea.

The most common hematology laboratory abnormalities (40%) with DARZALEX FASPRO are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin.

Please see full Prescribing Information at http://www.DARZALEX.com.

DARZALEX IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONSDARZALEX (daratumumab) is contraindicated in patients with a history of severe hypersensitivity (e.g., anaphylactic reactions) to daratumumab or any of the components of the formulation.

WARNINGS AND PRECAUTIONSInfusion Reactions DARZALEX can cause severe and/or serious infusion reactions, including anaphylactic reactions. In clinical trials, approximately half of all patients experienced an infusion reaction. Most infusion reactions occurred during the first infusion and were Grade 1-2. Infusion reactions can also occur with subsequent infusions. Nearly all reactions occurred during infusion or within 4 hours of completing DARZALEX.Prior to the introduction of post-infusion medication in clinical trials, infusion reactions occurred up to 48 hours after infusion. Severe reactions have occurred, including bronchospasm, hypoxia, dyspnea, hypertension, laryngeal edema, and pulmonary edema. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, and hypotension.

Pre-medicate patients with antihistamines, antipyretics, and corticosteroids. Frequently monitor patients during the entire infusion. Interrupt infusion for reactions of any severity and institute medical management as needed. Permanently discontinue therapy if an anaphylactic reaction or life-threatening (Grade 4) reaction occurs and institute appropriate emergency care.For patients with Grade 1, 2, or 3reactions, reduce the infusion rate when re-starting the infusion.

To reduce the risk of delayed infusion reactions, administer oral corticosteroids to all patients following DARZALEX infusions. Patients with a history of chronic obstructive pulmonary disease may require additional post-infusion medications to manage respiratory complications. Consider prescribing short- and long-acting bronchodilators and inhaled corticosteroids for patients with chronic obstructive pulmonary disease.

Interference with Serological Testing Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab infusion. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type are not impacted. Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX. Type and screen patients prior to starting DARZALEX.

Neutropenia and Thrombocytopenia DARZALEX may increase neutropenia and/or thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to the manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection.DARZALEX dose delay may be required to allow recovery of neutrophils and/or platelets. No dose reduction of DARZALEX is recommended. Consider supportive care with growth factors for neutropenia or transfusions for thrombocytopenia.

Interference with Determination of Complete Response Daratumumab is a human IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.

Adverse Reactions The most frequently reported adverse reactions (incidence 20%) were: infusion reactions, neutropenia, thrombocytopenia, fatigue, asthenia, nausea, diarrhea, constipation, decreased appetite, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy, bronchitis, pneumonia, and upper respiratory tract infection.

DARZALEX in combination with lenalidomide and dexamethasone (DRd): The most frequent (20%) adverse reactions for newly diagnosed or relapsed/refractory patients were, respectively, infusion reactions (41%, 48%), diarrhea (57%, 43%), nausea (32%, 24%), fatigue (40%, 35%), pyrexia (23%, 20%), upper respiratory tract infection (52%, 65%), muscle spasms (29%, 26%), dyspnea (32%, 21%), and cough (30%, 30%). In newly diagnosed patients, constipation (41%), peripheral edema (41%), back pain (34%), asthenia (32%), bronchitis (29%), pneumonia (26%), peripheral sensory neuropathy (24%), and decreased appetite (22%) were also reported. In newly diagnosed patients, serious adverse reactions (2% compared to Rd)were pneumonia (15%), bronchitis (4%), and dehydration (2%), and treatment-emergent Grade 3-4 hematology laboratory abnormalities (20%) were neutropenia (56%), lymphopenia (52%), and leukopenia (35%). In relapsed/refractory patients, serious adverse reactions (2% compared to Rd)were pneumonia (12%), upper respiratory tract infection (7%), influenza (3%), and pyrexia (3%), and treatment-emergent Grade 3-4 hematology laboratory abnormalities (20%) were neutropenia (53%) and lymphopenia (52%).

DARZALEXin combination with bortezomib, melphalan, and prednisone (DVMP): The most frequently reported adverse reactions (20%) were upper respiratory tract infection (48%), infusion reactions (28%), and peripheral edema (21%). Serious adverse reactions (2% compared to the VMP arm) were pneumonia (11%), upper respiratory tract infection (5%), and pulmonary edema (2%). Treatment-emergent Grade 3-4 hematology laboratory abnormalities (20%) were lymphopenia (58%), neutropenia (44%), and thrombocytopenia (38%).

DARZALEX in combination with bortezomib and dexamethasone (DVd): Themost frequently reported adverse reactions (20%) were peripheral sensory neuropathy (47%), infusion reactions (45%), upper respiratory tract infection (44%), diarrhea (32%), cough (27%), peripheral edema (22%), and dyspnea (21%). The overall incidence of serious adverse reactions was 42%. Serious adverse reactions (2% compared to Vd) were upper respiratory tract infection (5%), diarrhea (2%), and atrial fibrillation (2%). Treatment-emergent Grade 3-4 hematology laboratory abnormalities (20%) were lymphopenia (48%) and thrombocytopenia (47%).

DARZALEX in combination with bortezomib, thalidomide, and dexamethasone (DVTd): The most frequent adverse reactions (20%) were infusion reactions (35%), nausea (30%), upper respiratory tract infection (27%), pyrexia (26%), and bronchitis (20%). Serious adverse reactions (2% compared to the VTd arm) were bronchitis (DVTd 2% vs. VTd <1%)and pneumonia (DVTd 6% vs. VTd 4%). Treatment-emergent Grade 3-4 hematology laboratory abnormalities (20%) were lymphopenia (59%), neutropenia (33%), and leukopenia (24%).

DARZALEX in combination with pomalidomide and dexamethasone (DPd): Themost frequent adverse reactions (>20%) were fatigue (50%), infusion reactions (50%), upper respiratory tract infection (50%), cough (43%), diarrhea (38%), constipation (33%), dyspnea (33%), nausea (30%), muscle spasms (26%), back pain (25%), pyrexia (25%), insomnia (23%), arthralgia (22%), dizziness (21%), and vomiting (21%). The overall incidence of serious adverse reactions was 49%. Serious adverse reactions reported in 5% of patients included pneumonia (7%).Treatment-emergent Grade 3-4 hematologylaboratory abnormalities (20%) were neutropenia (82%), lymphopenia (71%), and anemia (30%).

DARZALEX as monotherapy: Themost frequently reported adverse reactions (20%) were infusion reactions (48%), fatigue (39%), nausea (27%), back pain (23%), pyrexia (21%), cough (21%), and upper respiratory tract infection (20%). The overall incidence of serious adverse reactions was 33%. The most frequent serious adverse reactions were pneumonia (6%), general physical health deterioration (3%), and pyrexia (3%). Treatment-emergent Grade 3-4 hematology laboratory abnormalities (20%) were lymphopenia (40%) and neutropenia (20%).

Please see full Prescribing Information at http://www.DARZALEX.com.

About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at http://www.janssen.com. Follow us at http://www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding DARZALEX FASPRO. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov, http://www.jnj.comor on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

ENHANZEis a registered trademark of Halozyme.

1Mateos M-V et al. Efficacy and Safety of the Randomized, Open-Label, Non-inferiority, Phase 3 Study of Subcutaneous (SC) Versus Intravenous (IV) Daratumumab (DARA) Administration in Patients (pts) With Relapsed or Refractory Multiple Myeloma (RRMM): COLUMBA. 2019 American Society of Clinical Oncology Annual Meeting. June 2019.

2Janssen Research & Development, LLC. A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [cited July 5, 2019]. Available at: https://clinicaltrials.gov/ct2/show/NCT03412565. Identifier: NCT03412565.

32020Fedele G et al. CD38 Ligation in Peripheral Blood Mononuclear Cells of Myeloma Patients Induces Release of Protumorigenic IL-6 and Impaired Secretion of IFN Cytokines and Proliferation. Mediators Inflamm. 2013;564687.

4Janssen Research & Development, LLC. A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02076009?term=mmy3003&rank=1 Identifier: NCT02136134 .

5Janssen Research & Development, LLC. Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02136134?term=mmy3004&rank=1 Identifier: NCT02076009.

6Janssen Research & Development, LLC. A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma (Cassiopeia). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02541383?term=mmy3006 Identifier: NCT02541383.

7Janssen Research & Development, LLC. A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02195479?term=mmy3007&rank=1 Identifier: NCT02195479.

8Janssen Research & Development, LLC. Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02252172?term=mmy3008&rank=1 Identifier: NCT02252172.

9Janssen Research & Development, LLC. A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT03217812?term=MMY3011&rank=1 Identifier: NCT03217812.

10European Myeloma Network. Compare Progression Free Survival Btw Daratumumab/Pomalidomide/Dexamethasone vs Pomalidomide/Dexamethasone (EMN14). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24] Available at: https://clinicaltrials.gov/ct2/show/NCT03180736?term=MMY3013&rank=2 Identifier: NCT03180736

11Amgen. Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma. (CANDOR). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24] Available at: https://clinicaltrials.gov/ct2/show/NCT03158688?term=NCT03158688&rank=1 Identifier: NCT03158688.

12Janssen Research & Development, LLC. A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 March 19]. Available at: https://clinicaltrials.gov/ct2/show/NCT02316106?term=smm2001&rank=1 Identifier: NCT02316106.

13Janssen Research & Development, LLC. An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 March 19]. Available at: https://clinicaltrials.gov/ct2/show/NCT02413489?term=lym2001&rank=1 Identifier: NCT02413489

14Janssen Biotech, Inc. "Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab." Issued August 30, 2012.

15Janssen Biotech, Inc. "DARZALEX (daratumumab) Approved by U.S. FDA: First Human Anti-CD38 Monoclonal Antibody Available for the Treatment of Multiple Myeloma." Issued November 16, 2015.

16Janssen Biotech, Inc. "DARZALEX (daratumumab) Approved by U.S. FDA in Combination with Two Standard of Care Regimens for the Treatment of Patients with Multiple Myeloma Who Have Received At Least One Prior Therapy." Issued November 21, 2016.

17Janssen Biotech, Inc. "DARZALEX (daratumumab) Approved by the U.S. FDA in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma Who Have Received At Least Two Prior Therapies." Issued June 16, 2017.

18Janssen Biotech, Inc. "Janssen Announces DARZALEX (daratumumab) U.S. FDA Approval for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible." Issued May 7, 2018.

19Janssen Biotech, Inc. "Janssen Announces U.S. FDA Approval of DARZALEX (daratumumab) in Combination with Lenalidomide and Dexamethasone for Newly Diagnosed Patients with Multiple Myeloma Who Are Transplant Ineligible." Issued June 27, 2019.

20Janssen Biotech, Inc. "Janssen Announces U.S. FDA Approval of DARZALEX (daratumumab) Combination Regimen for Newly Diagnosed, Transplant-Eligible Patients with Multiple Myeloma." Issued September 26, 2019.

21Kumar, SK et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012 Jan; 26(1):149-57.

22American Cancer Society. "What Is Multiple Myeloma?" Available at: http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma. Accessed June 2019.

23American Cancer Society. "Key Statistics About Multiple Myeloma." Available at: https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html. Accessed January 2020.

Media contacts:Bernadette KingPhone: +1 (215) 778-3027

Satu GlawePhone: +49 (172) 294-6264

Investor Relations:Christopher DelOreficePhone: +1 (732) 524-2955

Jennifer McIntyrePhone: +1 (732) 524-3922

U.S. Medical Inquiries:+1 (800) 526-7736

View original content to download multimedia:http://www.prnewswire.com/news-releases/us-food-and-drug-administration-approves-darzalex-faspro-daratumumab-and-hyaluronidase-fihj-a-new-subcutaneous-formulation-of-daratumumab-in-the-treatment-of-patients-with-multiple-myeloma-301051154.html

SOURCE The Janssen Pharmaceutical Companies of Johnson & Johnson

Follow this link:
US Food and Drug Administration Approves DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a New Subcutaneous Formulation of Daratumumab in the...

COVID-19 Outbreak Bestows Lucrative Opportunities to Rheumatoid Arthritis Stem Cell Therapy Market; Demand to Remain High Post Pandemic – Latest…

COVID-19 Analysis on the Global Rheumatoid Arthritis Stem Cell Therapy Market

A recent market research report on the Rheumatoid Arthritis Stem Cell Therapy market published by Fact.MR is an in-depth assessment of the current landscape of the market. Further, the report elaborates on the impact of the COVID-19 on the Rheumatoid Arthritis Stem Cell Therapy market and provides a thorough understanding of the growth potential of each market segment over the forecast period (2020-2030).

According to the analyst at Fact.MR, the Rheumatoid Arthritis Stem Cell Therapy market is evenly slated to register a CAGR growth of ~XX% during the assessment period and attain a value of ~US$ XX by the end of 2030. The report analyzes the micro and macro-economic factors that are projected to impact the growth of the Rheumatoid Arthritis Stem Cell Therapy market in the upcoming years. Further, a detailed analysis of the business continuity strategies of leading market participants is enclosed in the presented report.

Request Sample Report @ https://www.factmr.co/connectus/sample?flag=S&rep_id=1001

Key Insights Enclosed in the Report

Segmentation of the Rheumatoid Arthritis Stem Cell Therapy Market

The presented report dissects the Rheumatoid Arthritis Stem Cell Therapy market into different segments and ponders over the current and future prospects of each segment. The report depicts the year-on-year growth of each segment and touches upon the different factors that are likely to influence the growth of each market segment. Further, projections are made taking into account the impact of the COVID-19 pandemic on the each market segment.

The various segments of the Rheumatoid Arthritis Stem Cell Therapy market analyzed in the report include:

Competitive landscape

Request Methodology On This Report @ https://www.factmr.co/connectus/sample?flag=RM&rep_id=1001

Important doubts related to the Rheumatoid Arthritis Stem Cell Therapy market clarified in the report:

Why Choose Fact.MR

Ask analyst about this report at https://www.factmr.co/connectus/sample?flag=AE&rep_id=1001

Read more from the original source:
COVID-19 Outbreak Bestows Lucrative Opportunities to Rheumatoid Arthritis Stem Cell Therapy Market; Demand to Remain High Post Pandemic - Latest...

Global 3D Cell Culture Market 2020 | What Is The Estimated Market Size In The Upcoming Years? Cole Reports – Cole of Duty

A recently released report titledGlobal 3D Cell Culture Market Growth (Status and Outlook) 2020-2024is made covering in-depth analysis of market size, commercialization aspects, profit estimations, market share, and revenue forecast of the industry from 2020 to 2024 time-frame. The report provides details on every category of the global 3D Cell Culture market like the product, technology, application, and end-user. It explicitly highlights the competitive status of key players focusing on growth strategies implemented by the service providers within the projection timeline while focusing on their portfolio and regional expansion ventures.

Ask For Sample Report @ https://www.reportspedia.com/report/life-sciences/global-3d-cell-culture-market-2019-by-manufacturers,-regions,-type-and-application,-forecast-to-2024/2238 #request_sample

The report includes data analysis about the market status, competition pattern, advantages and disadvantages of enterprise products, development trends, and regional industrial layout characteristics. Later the study throws light on the product scope, market opportunities, market risk, and market driving force as well as provides top manufacturers sales, revenue, and price by regional and country wise analysis. The research report includes technical data, manufacturing plants analysis, and raw material sources analysis of the global 3D Cell Culture industry.

Key Players:

Thermo Fisher ScientificCorningLonza GroupKuraray CoMerck KgaaInspheroN3d BioscienceReprocell Incorporated3D Biotek

If You Have Any Query, Ask Our Experts @ https://www.reportspedia.com/report/life-sciences/global-3d-cell-culture-market-2019-by-manufacturers,-regions,-type-and-application,-forecast-to-2024/2238 #inquiry_before_buying

The 3D Cell Culture Market Segmentation By Types:

Scaffold-basedScaffold-free

The 3D Cell Culture Market Segmentation By Applications:

Cancer ResearchStem Cell ResearchDrug DiscoveryRegererative Medicine

A Comprehensive Structure of The Regional Scope:

For a complete understanding of the market dynamics, the global 3D Cell Culture market is analyzed through key geographic areas, namely:Americas (United States, Canada, Mexico, Brazil), APAC (China, Japan, Korea, Southeast Asia, India, Australia), Europe (Germany, France, UK, Italy, Russia), Middle East & Africa (Egypt, South Africa, Israel, Turkey, GCC Countries). The study comprises of details regarding the market share amassed by each region. Additionally, details about the growth prospects for all the regions have been specified in the report. The approximate growth rate to be recorded by each region throughout the forecast period has been stated within the research study.

Moreover, a team of experienced market research professionals and experts continuously tracks key industries to spot key developments, needs, and possible growth opportunities as well as marketing strategies, trends, future products, and rising opportunities. Comprehensive analysis of the historical data and contemporary global 3D Cell Culture market scenario to interpret industry size, volume, share, growth, and sales have been given in the report.

Attractions of The Report:

Customization of the Report:

This report can be made-to-order the clients requirements. Please connect with our sales team (Mail Id), who will ensure that you get a report that suits your needs. You can also get in touch with our executives on (+1(617)2752538) to share your research requirements.

Get Full Table of content @ https://www.reportspedia.com/report/life-sciences/global-3d-cell-culture-market-2019-by-manufacturers,-regions,-type-and-application,-forecast-to-2024/2238 #table_of_contents

More:
Global 3D Cell Culture Market 2020 | What Is The Estimated Market Size In The Upcoming Years? Cole Reports - Cole of Duty

San Diego biotech firm seeks approval for stem cell research against COVID-19 – CBS News 8

Personalized Stem Cells Incorporated (PSC) in Poway said the therapy could reduce the most serious complications of the infection in the lungs.

SAN DIEGO A San Diego biotech company is seeking emergency FDA approval for an experimental trial of stem cell therapy for coronavirus patients.

Personalized Stem Cells Incorporated (PSC) in Poway said the therapy could reduce the most serious complications of the infection in the lungs.

PSC CEO, Dr. Bob Harman, said the company is asking to test the treatment on a group of 20 hospitalized COVID-19 patients in the first phase of a clinical trial.

"Stem cell doses will be ready for clinical trial use in May, depending on FDA approval," Harman said.

Harman said they've already scaled up production of stem cells in anticipation of FDA approval.

PSC Medical Director, Dr. Christopher Rogers, stated, "I believe this is the most promising therapy being explored by medical scientists at this time and stem cells may potentially reduce the most serious complications of coronavirus infection."

The FDA has a new program called the Coronavirus Therapeutic Accelerator Program (CTAP) to help speed up the launch of FDA clinical trials for hopeful COVID-19 therapies.

PSC was asked by the White House Coronavirus Task Force to apply to the FDA CTAP program for expedited review of their application.

PSC hopes to rapidly complete the CoronaStem 1 study and then proceed into a larger Phase 2 clinical trial and potentially into FDA compassionate use programs to reach more patients.

More information can be found on the PSC website.

Continue reading here:
San Diego biotech firm seeks approval for stem cell research against COVID-19 - CBS News 8

Amniotic Membrane Market: Locally Available Amniotic Allografts Increasingly Meeting Needs of Patients with Joint Pain – BioSpace

Transparency Market Research (TMR)has published a new report on theamniotic membrane marketfor the forecast period of2019-2027. According to the report, the global amniotic membrane market was valued at ~US$ 980 Mnin2018and is projected to expand at a CAGR of ~10%from2019to2027.

GlobalAmniotic Membrane Market:Overview

Request for Brochure of Report - https://www.transparencymarketresearch.com/sample/sample.php?flag=B&rep_id=42059

Increase in Research on Stem Cell Biology & Regenerative Medicineto Drive Market

Cryopreserved Amniotic Membrane Products to Dominate Market

Request for Analysis of the COVID19 Impact on Amniotic Membrane Market - https://www.transparencymarketresearch.com/sample/sample.php?flag=covid19&rep_id=42059

Ophthalmology to be Promising Application

Hospitals Account for Major Share of Global Market

North America to Dominate Global Amniotic Membrane Market

Request for Custom Research - https://www.transparencymarketresearch.com/sample/sample.php?flag=CR&rep_id=42059

Global Amniotic Membrane Market: Competitive Landscape

About Us

Transparency Market Research is a next-generation market intelligence provider, offering fact-based solutions to business leaders, consultants, and strategy professionals.

Our reports are single-point solutions for businesses to grow, evolve, and mature. Our real-time data collection methods along with ability to track more than one million high growth niche products are aligned with your aims. The detailed and proprietary statistical models used by our analysts offer insights for making right decision in the shortest span of time. For organizations that require specific but comprehensive information we offer customized solutions through ad hoc reports. These requests are delivered with the perfect combination of right sense of fact-oriented problem solving methodologies and leveraging existing data repositories.

TMR believes that unison of solutions for clients-specific problems with right methodology of research is the key to help enterprises reach right decision.

Contact

Transparency Market ResearchState Tower,90 State Street,Suite 700Albany NY - 12207United StatesUSA - Canada Toll Free: 866-552-3453Email:sales@transparencymarketresearch.comWebsite:https://www.transparencymarketresearch.com

Go here to read the rest:
Amniotic Membrane Market: Locally Available Amniotic Allografts Increasingly Meeting Needs of Patients with Joint Pain - BioSpace

MDimune Signed a Research Collaboration Agreement with Paracelsus Medical University for EV Therapeutics Development – BioSpace

MDimune Inc., a cell-derived vesicle (CDVs)-based therapeutics company with BioDrone platform technology, announced on April 30th, 2020, the signature of a research collaboration agreement with Paracelsus Medical University (PMU, Salzburg, Austria). PMU will bring their experience to further the companys global development goals.

Those in attendance from PMU were Herbert Resch, Professor and Rector; Michael Nake, Chancellor; Eva Rohde, Professor, Vice Rector and Director of GMP laboratory; and Mario Gimona, Associate Professor and Head of Production GMP. Those in attendance from MDimune were Shin Gyu Bae, Chief Executive Officer; Seung Wook Oh, Chief Scientific Officer; Tae Kee Jeong, Chief Financial Officer; and Hui-Chong Lau, Manager of the CMC team.

The agreement states that PMU will develop a process for producing CDV therapeutics at GMP-compliant scale as well as supply them for the pre-clinical study and the initial phase of human clinical study. PMU has also agreed to establish GMP-grade mesenchymal stem cell banks derived from umbilical cords for MDimune, which will then be used to produce CDVs required for various preclinical and clinical development.

EVs, especially exosomes, have emerged as a novel therapeutic with their roles in intercellular communications. However, the fact that they only naturally occur in minuscule quantities and the difficulties involved in large-scale production have prevented a rapid progress in the commercialization of EVs. MDimune developed BioDrone platform technology to overcome these critical limitations in EV therapeutics. MDimune anticipates that the research collaboration with PMU will accelerate the development of CDVs in therapeutics and the initiation of clinical trials in the US, Europe, and Asia, which will lead to more partnerships in the global market.

MDimune also announced the appointment of Dr. Mario Gimona, a leading exosome expert, as Chief Manufacturing Officer. Dr. Gimona has been heading the stem cell and extracellular vesicle (EV) production unit at PMUs GMP laboratory as well as investigating the clinical potential of multipotent mesenchymal stem cell-derived EVs in the field of regenerative medicine. With his expertise in manufacturing of EV therapeutics, he will be able to help advance the clinical applications of BioDrone platform technology.

We are thrilled to announce a joint research endeavor with Paracelsus Medical University. We are confident that this collaboration will expedite the entry into the clinical phase of development for the company, which will allow us to become a global leader in the field of EV therapeutics and ultimately provide a cure for many patients with devastating diseases around the world, said Bae, CEO of MDimune. Dr. Resch, Rector of PMU also emphasized that combining the individual strengths of MDimune and PMU`s GMP unit will enhance therapy development and ultimately change people`s lives.

About MDimune, Inc.

Founded in 2015, MDimune has been dedicated to changing the world by developing innovative therapeutics. The company has developed BioDrone platform technology, which is a novel technology that uses cell-derived vesicles to achieve highly target-specific drug delivery. The BioDrone platform technology is patented in the US, Europe, China, Japan, and Korea. MDimunes current programs are focused on cancer, COPD and other rare diseases. MDimune is actively pursuing business partnerships with biotech, pharmaceuticals, and hospitals for the potential application of the BioDrone technology in various unmet medical needs. In 2019, MDimune opened its U.S. affiliate BioDrone Therapeutics Inc. in Seattle, WA, to facilitate its global business development.

For more information, visit the company's website at http://mdimune.com/

Contact

Media:

Jinah Han, Ph.D., Consultant, BD (to.jinah.han@gmail.com)

Investor:

Seung Wook Oh, Ph.D. Chief Scientific Officer (swoh@mdimune.com; info@biodroneus.com)

MDimune Inc.

#1003 KOLON Digital Tower-III, 49 Achasan-ro, Seongdong-gu

Seoul 04790 Korea

Tel +82. 2. 2655. 2636

http://www.mdimune.com

Biodrone Therapeutics Inc.

4000 Mason Rd. Suite 300

Seattle, WA 98195

http://www.biodroneus.com

Original post:
MDimune Signed a Research Collaboration Agreement with Paracelsus Medical University for EV Therapeutics Development - BioSpace

Covid-19: How scientists are keeping politics out of the global race for a vaccine – FRANCE 24 English

As the world races to combat the coronavirus, one nation is notably absent from multinational efforts: the United States.But scientists say that for now, the international research community is working together to do all it can.

Global actors are joining forces on multiple fronts to bring the coronavirus pandemic under control. On April 24, the World Health Organization (WHO) held a virtual conference to launch an international collaboration to accelerate the development and production of the health technologies necessary to do so. The United States did not participate in the conference, which culminated in a joint call for action.

Next Monday, May 4, the European Commission will respond to that call by hosting a global virtual conference to raise money from countries and business foundations to fund the development of tests, treatments and a vaccine for the coronavirus. It has invited governments, business leaders, public figures, philanthropists, artists and citizens to help with its efforts to raise the 7.5 billionit has set as its initial target. Announced partners include France, Germany, the United Kingdom, Norway and Saudi Arabia. It remains unclear if the US will take part.

Under President Donald Trumps America First doctrine, the US has tended to favour unilateral action and eschew cooperation with international organisations. Case in point: On March 14, Trump announced that he was suspending funding to the WHO, which has spearheaded the global response to the pandemic. With an annual input of about $400 million, the US is the biggest contributor to the organisation; the reduction in funds comes at a vital moment.

What all that will mean in the battle against a virus that as global health experts have repeatedly reminded us knows no borders and requires coordinated actionremains to be seen.

Politics a separate sphere from science

On the scientific front, the impact may be minimal. While global cooperation and the sharing of expertise and information is critical, it also happens largely without government involvement and, as of now, continues unimpeded, said Laurent Humeau, chief scientific officer at Inovio Pharmaceuticals.

Humeaus team has relied on the sequencing of the genome provided by China, genetic material from Australia and has cooperated with researchers in South Korea and the UK. Its a community that is moving very fast and we need everyone elses help to get a vaccine, he said. Its absolutely critical for us to have this network of scientists.

The Inovio team is part of the WHOs R & D Blueprint, which pulls together a coalition of experts and allows for the rapid activation of research and development activities during epidemics.

And despite the public distance between the US and the WHO, key health personnel from the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health continue to be part of the global scientific dialogue. For now, the international research community is working together to do all it can. We keep pushing as fast its not as fast as we can run, but as fast as we can fly, Humeau said.

Unless governments issue restrictions such as those the US imposed on stem-cell research politics tends to exist in a sphere separate from science, said Gregory Poland, director of the Mayo Clinics Vaccine Research Group andwho also edits the international journal Vaccine. Youre not working in a political framework at least in the US youre working in a scientific framework, Poland said.

Researchers end up primarily communicating through journals and meetings and, perhaps most importantly in the current crisis, on "preprint servers", where researchers place articles before they have gone through peer review and been published. That has been the primary way that scientists have been communicating with one another, Poland said.

There may even be a silver lining to a little bit of distance between researchers, said Peter Hotez, dean for the National School of Medicine at the Baylor College of Medicine. The US and Europe sometimes have different approaches to vaccine development and how to support vaccine science, and that may not be so bad because it creates additional opportunities for innovation, he said.

Pushed to the bottom?

Poland hopes that this pandemic, unlike the ones that preceded it, will finally have helped people understand how interrelated their nations are. Weve had multiple examples now, that anything that happens anywhere on this globe is maybe, at most, 36 hours away from Europe or North America, he said. Theres where you need a lot of cooperation, for example, on surveillance, on what is happening where, because literally days are lives.

Finding a vaccine is only a first step, warned David Salisbury, associate fellow in the Global Health Programme at Chatham House. The fact that scientists are talking to each other is admirable, because sharing what we are learning about vaccine development is, of course, hugely important," Salisbury said. But that is the beginning of the story Ultimately, weve got to get from developing a vaccine to manufacturing and buying it country by country, and then were into a political world that has left the scientists behind The critical thing is not when do we get the first dose, its when do we get enough.

Manufacturing and distributing a vaccine will be herculean tasks for a disease that potentially affects everyone on the planet, and thats where a new set of potential problems arises. You could imagine a philosophy of America First that might actually prevent vaccines manufactured in the US from leaving the US until everyone [there] had been vaccinated, Salisbury said. Or what if the EU says we will prioritise European customers first? Geopolitics becomes really important in what becomes available when and for whom.

Salisbury said that countries that cant afford to pay market rate also risk getting pushed to the bottom of this great long list of customers. The international community needs to consider carefully how what are certain to be scarce supplies to begin with get distributed.

How do we share a hugely valuable resource equitably? he asked. I dont know that we have a solution yet.

Read the original post:
Covid-19: How scientists are keeping politics out of the global race for a vaccine - FRANCE 24 English

Bone Marrow Transplantation Market to Register CAGR 3.6% Increase in Revenue by 2028 End – Cole of Duty

In addition to rapid expansion of bone marrow donor registry, increasing commercialization of cellular therapy and tissue engineering, increased survival rate post bone marrow transplant procedures, and easier access to treatment will be some of the most prominent factors driving thebone marrow transplantation market.

According to the latest research by Persistence Market Research, the global bone marrow transplantation market is expected to exceed US$ 12 Bn by the end of 2028. The bone marrow transplantation market is expected to grow at a CAGR of 3.6% through the forecast period 2018-2028.

Report Highlights:

Get Sample Copy of Report @ https://www.persistencemarketresearch.com/samples/4288

Company Profile

North America Will Continue to Lead the Pack in Bone Marrow Transplantation Market

Increasing per-capita healthcare and private insurance expenditure is a major factor that is expected to maintain the high demand for technologically advanced treatment procedures, such as bone marrow transplantation, over the forecast period. Increasing blood cancer cases and geriatric population are among the key factors expected to boost the demand for bone marrow transplantation in North America.

The increasing prevalence of myeloma in the region is leading to an increase in the execution of bone marrow transplantation procedures through the allogeneic method. Companies engaged in stem cell therapies are expanding their product portfolio to offer sound treatment solutions for diseases caused while undergoing the allogeneic transplant method.

The availability of more than 90% unrelated donors and high healthcare expenditure are among the factors driving the overall bone marrow transplantation market in North America at present.

The American Society for Blood and Marrow Transplant reported an increasing prevalence of leukemia and lymphoma in patients aged 65 years and above, and this age group constituted 25-30% of the total number of bone marrow transplantation recipients in 2014.

In 2015, the Senate and House of Representatives of the US reauthorized the Stem Cell Therapeutic and Research Act of 2005, which led to an increase in the US unrelated donors registry to 200,000 donors.

Germany Will Steer Europes Market for Bone Marrow Transplantation

Rise in per capita GDP is expected to improve the healthcare expenditure in countries such as Germany and Spain. Government policymakers are forcing healthcare providers and public payers to disclose the cost charged and reimbursed to maintain price transparency. Healthcare organizations in Germany spend most of their research funding on adult stem cell research.

Furthermore, Germany spends 11.3% of its GDP on healthcare, which is above the global average. This, in turn, has led to the presence of better healthcare facilities and more advanced research findings on various healthcare issues such as bone marrow transplantation.

Among the 680 centers throughout the Europe, 226 (35%) centers are dedicated to autologous bone marrow transplantation in 2014, with most of the transplants intended for non-malignant disorders. These factors are expected to drive the bone marrow transplantation market in Europe.

Get To Know Methodology of Report @ https://www.persistencemarketresearch.com/methodology/4288

APAC Reflects Lucrative Potential for Penetration of Bone Marrow Transplantation Procedures

Rise in the number of bone marrow transplantation centers and expanding donor registry are among the factors expected to reduce the gap between bone marrow transplantation providers and recipients in the Asia Pacific bone marrow transplantation market.

The availability of modern healthcare amenities, along with the presence of several companies engaged in stem cell therapies in China, Australia, and Japan, is expected to be a key factor driving the overall bone marrow transplantation market in Asia Pacific.

After the introduction of alleviating procedures for Peripheral Blood Stem Cell (PBSC) transplant, there has been an increase in the number of allogeneic HSCT procedures using PBSC (64% of the total HSCT) in Australia & New Zealand, which is another factor contributing to the growth of the bone marrow transplantation market in the region.

A survey by the Eastern Mediterranean Blood and Marrow Transplant (EMBMT) Group suggests that non-malignant indications accounted for a 36.5% share of the total bone marrow transplantation activities carried out in the MEA region. Countries such as Dubai and Qatar are undertaking initiatives to develop national bone marrow registries to enhance bone marrow transplantation rates.

Access Full Report @ https://www.persistencemarketresearch.com/checkout/4288

The report offers a comprehensive taxonomy of the bone marrow transplantation market based on the transplantation type, indication, end user, and region.

Continued here:
Bone Marrow Transplantation Market to Register CAGR 3.6% Increase in Revenue by 2028 End - Cole of Duty

(COVID-19 UPDATE)Mesenchymal Stem Cells MARKET TO WITNESS INCREASED REVENUE GROWTH OWING TO HEIGHTENED PRODUCT INNOVATIONS IN THE COVID-19 PANDEMIC -…

Mesenchymal Stem Cells Market Latest Research PDF Of COVID 19 Impact Study By eSherpa Market Reports | Top players Genlantis, Inc., Stem cell technologies Inc., Cytori Therapeutics Inc., BrainStorm Cell Therapeutics., Cyagen Biosciences Inc., Aastrom Biosciences, Axol Bioscience Ltd., Advanced Cell Technology Incorporated, EMD Millipore Corporation, Stemedica Cell Technologies, Inc., R&D Systems, Inc., ScienCell Research Laboratories., Cell Applications, Inc., Celprogen, Inc.

Mesenchymal Stem Cells Market Report is exclusive and talks in detail about the current market situations. Also, about the overall market journey in the previous five years along with the prophecy made by the experts in the industry. However, the report also provides the necessary SWOT analysis as its one of the main elements.

In revenue terms, in the worldwide market, the Mesenchymal Stem Cells Market is forecasted to generate the XX% CAGR. the market share, sales, and revenues are shared in this report for the XX industry, from the worldwide market. According to the forecast the worldwide market for the Mesenchymal Stem Cells industry will reach from $XX billion in 2020 to $XX billion in 2027. The market will show the XX% profit in the Mesenchymal Stem Cells industry in the next 7 years.

Get Free Sample PDF Copy (including COVID19 Impact Analysis, full TOC, Tables, and Figures) of Mesenchymal Stem Cells Market Report @ https://www.esherpamarketreports.com/request-sample/es-412584/

Key Businesses Segmentation of Mesenchymal Stem Cells Market:

Global Mesenchymal Stem Cells Market Segment by Type, covers

Global Mesenchymal Stem Cells Market Segment by Applications, can be divided into

The Mesenchymal Stem Cells Market Report Can Answer The Following Questions:

Enquire before purchasing this report @ https://www.esherpamarketreports.com/pre-order-enquiry/es-412584

Table of Contents

1 Mesenchymal Stem Cells Market Overview1.1 Product Overview and Scope of Mesenchymal Stem Cells1.2 Mesenchymal Stem Cells Segment by Type1.2.1 Global Mesenchymal Stem Cells Production and CAGR (%) Comparison by Type (2015-2027)1.3 Global Mesenchymal Stem Cells Segment by Application1.3.1 Mesenchymal Stem Cells Consumption (Sales) Comparison by Application (2015-2027)1.4 Global Mesenchymal Stem Cells Market by Region (2015-2027)1.4.1 Global Mesenchymal Stem Cells Market Size (Value) and CAGR (%) Comparison by Region (2015-2027)1.4.2 United States Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.3 Europe Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.3.1 Germany Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.3.2 UK Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.3.3 France Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.3.4 Italy Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.3.5 Spain Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.3.6 Russia Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.3.7 Poland Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.4 China Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.5 Japan Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.6 India Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.7 Southeast Asia Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.7.1 Malaysia Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.7.2 Singapore Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.7.3 Philippines Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.7.4 Indonesia Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.7.5 Thailand Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.7.6 Vietnam Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.8 Central and South America Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.8.1 Brazil Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.8.2 Mexico Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.8.3 Colombia Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.9 Middle East and Africa Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.9.1 Saudi Arabia Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.9.2 United Arab Emirates Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.9.3 Turkey Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.9.4 Egypt Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.9.5 South Africa Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.4.9.6 Nigeria Mesenchymal Stem Cells Market Status and Prospect (2015-2027)1.5 Global Market Size (Value) of Mesenchymal Stem Cells (2015-2027)1.5.1 Global Mesenchymal Stem Cells Revenue Status and Outlook (2015-2027)1.5.2 Global Mesenchymal Stem Cells Production Status and Outlook (2015-2027)2 Global Mesenchymal Stem Cells Market Landscape by Player2.1 Global Mesenchymal Stem Cells Production and Share by Player (2015-2020)2.2 Global Mesenchymal Stem Cells Revenue and Market Share by Player (2015-2020)2.3 Global Mesenchymal Stem Cells Average Price by Player (2015-2020)2.4 Mesenchymal Stem Cells Manufacturing Base Distribution, Sales Area and Product Type by Player2.5 Mesenchymal Stem Cells Market Competitive Situation and Trends2.5.1 Mesenchymal Stem Cells Market Concentration Rate2.5.2 Mesenchymal Stem Cells Market Share of Top 3 and Top 6 Players2.5.3 Mergers & Acquisitions, Expansion3 Players Profiles4 Global Mesenchymal Stem Cells Production, Revenue (Value), Price Trend by Type

. And More

Click Here For Detailed Table Of Contents

Reasons To Buy:

Purchase this Report with Full Access @ https://www.esherpamarketreports.com/purchase/es-412584/

Contact Us:

Name: Jason George

Email: sales@esherpamarketreports.com

Call :USA: +1 408 757 0510

Organization: eSherpa Market Reports

About Us:

eSherpa Market Reports is the credible source for gaining the market research reports that will exponentially accelerate your business. We are among the leading report resellers in the business world committed towards optimizing your business. The reports we provide are based on a research that covers a magnitude of factors such as technological evolution, economic shifts and a detailed study of market segment.

Read the original here:
(COVID-19 UPDATE)Mesenchymal Stem Cells MARKET TO WITNESS INCREASED REVENUE GROWTH OWING TO HEIGHTENED PRODUCT INNOVATIONS IN THE COVID-19 PANDEMIC -...