Animal Stem Cell Therapy Market Future Demand Analysis with Forecast 2020 to 2027 – PRnews Leader

Animal Stem Cell Therapy Market By Product Type and Application Global Industry Analysis & Forecast to 2027

The global Animal Stem Cell Therapy Market is anticipated to benefit industry growth inside the forecast duration of 2020 to 2027. the Animal Stem Cell Therapy industry is developing at a wholesome CAGR, forecast upto 2027

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Animal Stem Cell Therapy Market Future Demand Analysis with Forecast 2020 to 2027 - PRnews Leader

Genmab Announces that Janssen has Submitted a Type II Variation Application to the European Medicines Agency for use of Subcutaneous DARZALEX…

November 05, 2020 06:26 ET | Source: Genmab A/S

Media Release

Copenhagen, Denmark, November 5, 2020

Genmab A/S (Nasdaq: GMAB) announced today that Janssen Pharmaceutica NV (Janssen) has submitted a Type II variation application to the European Medicines Agency (EMA) for the subcutaneous (SC) formulation of daratumumab (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) for the treatment of adult patients with light-chain (AL) amyloidosis. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize daratumumab. The submission of this Type II variation application study triggers a USD 5 million milestone payment to Genmab.

We are extremely pleased about the submission for subcutaneous DARZALEX in patients with AL amyloidosis to the European Health Authorities based on the Phase 3 ANDROMEDA (AMY3001) study. We are hopeful that this will lead to the first approved treatment option for patients with this devastating disease which would also be the first approved indication for DARZALEX in Europe outside of multiple myeloma, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The submission is based on the Phase 3 ANDROMEDA study of daratumumab and hyaluronidase-fihj in combination with VCd as treatment for patients with newly diagnosed AL amyloidosis. The data were presented as a late-breaking abstract at the 25th European Hematology Association Annual Congress in June 2020.

The milestone associated with this submission does not impact Genmabs 2020 guidance.

About the ANDROMEDA (AMY3001) study The Phase 3 study (NCT03201965) included 388 patients newly diagnosed with AL amyloidosis. Patients were randomized to receive treatment with either daratumumab and hyaluronidase-fihj in combination with bortezomib (a proteasome inhibitor), cyclophosphamide (a chemotherapy), and dexamethasone (a corticosteroid) (VCd) or treatment with VCd alone. The primary endpoint of the study was the percentage of patients who achieve hematologic complete response.

About Light-chain (AL) Amyloidosis Amyloidosis is a disease that occurs when amyloid proteins, which are abnormal proteins, accumulate in tissues and organs. When the amyloid proteins cluster together, they form deposits that damage the tissues and organs. AL amyloidosis most frequently affects the heart, kidneys, liver, nervous system and digestive tract. There is currently no cure or existing approved therapies for AL amyloidosis though it can be treated with chemotherapy, dexamethasone, stem cell transplants and supportive therapies.1 It is estimated that in 2019 there were 4,388 diagnosed incident cases of AL amyloidosis in the five major European markets2

About DARZALEX(daratumumab) DARZALEX (daratumumab) has become a backbone therapy in the treatment of multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory

multiple myeloma who have received one to three previous lines of therapy; in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.3 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.

DARZALEX is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy4. Daratumumab is the first subcutaneous CD38 antibody approved in Europe for the treatment of multiple myeloma. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S.

In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit http://www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT 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; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.5 DARZALEX FASPRO is the first subcutaneous CD38 antibody approved in the U.S. for the treatment of multiple myeloma.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a persons own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).3,6,7,8,9

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

About Genmab Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company is the creator of the following approved antibodies: DARZALEX (daratumumab, under agreement with Janssen Biotech, Inc.) for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan, Kesimpta (subcutaneous ofatumumab, under agreement with Novartis AG), for the treatment of adults with relapsing forms of multiple sclerosis in the U.S. and TEPEZZA (teprotumumab, under agreement with Roche granting sublicense to Horizon Therapeutics plc) for the treatment of thyroid eye disease in the U.S. A subcutaneous formulation of daratumumab, known as DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in the U.S., has been approved in the U.S. and Europe for the treatment of adult patients with certain multiple myeloma indications. The first approved Genmab created therapy, Arzerra (ofatumumab, under agreement with Novartis AG), approved for the treatment of certain chronic lymphocytic leukemia indications, is available in Japan and is also available in other territories via compassionate use or oncology access programs. Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody platform for generation of bispecific antibodies, the HexaBody platform, which creates effector function enhanced antibodies, the HexElect platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Contact: Marisol Peron, Corporate Vice President, Communications & Investor Relations T: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations: Andrew Carlsen, Senior Director, Investor Relations T: +45 3377 9558; E: acn@genmab.com

This Media Release contains forward looking statements. The words believe, expect, anticipate, intend and plan and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmabs most recent financial reports, which are available on http://www.genmab.com and the risk factors included in Genmabs most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at http://www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; HuMax; DuoBody; DuoBody in combination with the DuoBody logo; HexaBody; HexaBody in combination with the HexaBody logo; DuoHexaBody; HexElect; and UniBody. Arzerra and Kesimpta are trademarks of Novartis AG or its affiliates. DARZALEX and DARZALEX FASPRO are trademarks of Janssen Pharmaceutica NV. TEPEZZA is a trademark of Horizon Therapeutics plc.

1 Mayo Clinic website: http://www.mayoclinic.com/health/amyloidosis/DS00431 2 Global Data, Amyloidosis: Epidemiology Forecast to 2029, June 2020 3 DARZALEX Prescribing information, August 2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761036s029lbl.pdf Last accessed August 2020 4 DARZALEX Summary of Product Characteristics, available at https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last accessed June 2020 5 DARZALEX FASPRO Prescribing information, May 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf Last accessed May 2020 6 De Weers, M et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. The Journal of Immunology. 2011; 186: 1840-1848. 7 Overdijk, MB, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015; 7: 311-21. 8 Krejcik, MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells, Promotes T-cell Expansion, and Skews T-cell Repertoire in Multiple Myeloma. Blood. 2016; 128: 384-94. 9 Jansen, JH et al. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells via Fc receptor-mediated crosslinking.Blood. 2012; 120(21): abstract 2974

Media Releaseno. 17 CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122

Genmab A/S Kalvebod Brygge 43 1560 Copenhagen V Denmark

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Genmab Announces that Janssen has Submitted a Type II Variation Application to the European Medicines Agency for use of Subcutaneous DARZALEX...

CRISPR/Cas9 Gene-Editing Therapy CTX001 for Severe Hemoglobinopathies Accepted for Plenary Presentation at the 62nd American Society of Hematology…

ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON, Nov. 04, 2020 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data in seven patients from two ongoing Phase 1/2 clinical trials of the investigational CRISPR/Cas9 gene-editing therapy CTX001 in severe hemoglobinopathies has been accepted for an oral presentation during the Plenary Scientific Session at the annual ASH Meeting and Exposition, which will take place virtually from December 5-8, 2020. Haydar Frangoul, M.D., Medical Director of Pediatric Hematology and Oncology at Sarah Cannon Research Institute, HCA Healthcares TriStar Centennial Medical Center, will deliver the presentation on behalf of all the authors on December 6, 2020.

An abstract posted online today includes data from five patients with three months to 15 months of follow-up after CTX001 infusion in the ongoing Phase 1/2 CLIMB-111 trial in transfusion-dependent beta thalassemia (TDT) and data from two patients with three months and 12 months of follow-up in the ongoing Phase 1/2 CLIMB-121 trial in severe sickle cell disease (SCD). Additional data will be presented at ASH, including longer-duration follow-up data for the patients included in the abstract and data for additional patients with greater than three months of follow-up.

CTX001 is being investigated in these two ongoing clinical trials as a potential one-time curative therapy for patients suffering from TDT and severe SCD.

The accepted abstract is now available on the ASH conference website.

About CTX001 CTX001 is an investigational, autologous, ex vivo CRISPR/Cas9 gene-edited therapy that is being evaluated for patients suffering from TDT or severe SCD, in which a patients hematopoietic stem cells are engineered to produce high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is a form of the oxygen-carrying hemoglobin that is naturally present at birth, which then switches to the adult form of hemoglobin. The elevation of HbF by CTX001 has the potential to alleviate transfusion requirements for TDT patients and reduce painful and debilitating sickle crises for SCD patients.

Based on progress in this program to date, CTX001 has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA). CTX001 has also been granted Orphan Drug Designation from the European Commission for both TDT and SCD, as well as Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for SCD.

CTX001 is being developed under a co-development and co-commercialization agreement between CRISPR Therapeutics and Vertex. Among gene-editing approaches being investigated/evaluated for TDT and SCD, CTX001 is the furthest advanced in clinical development.

About CLIMB-111 The ongoing Phase 1/2 open-label trial, CLIMB-Thal-111, is designed to assess the safety and efficacy of a single dose of CTX001 in patients ages 12 to 35 with TDT. The trial will enroll up to 45 patients and follow patients for approximately two years after infusion. Each patient will be asked to participate in a long-term follow-up trial.

About CLIMB-121 The ongoing Phase 1/2 open-label trial, CLIMB-SCD-121, is designed to assess the safety and efficacy of a single dose of CTX001 in patients ages 12 to 35 with severe SCD. The trial will enroll up to 45 patients and follow patients for approximately two years after infusion. Each patient will be asked to participate in a long-term follow-up trial.

About the Gene-Editing Process in These Trials Patients who enroll in these trials will have their own hematopoietic stem and progenitor cells collected from peripheral blood. The patients cells will be edited using the CRISPR/Cas9 technology. The edited cells, CTX001, will then be infused back into the patient as part of a stem cell transplant, a process which involves, among other things, a patient being treated with myeloablative busulfan conditioning. Patients undergoing stem cell transplants may also encounter side effects (ranging from mild to severe) that are unrelated to the administration of CTX001. Patients will initially be monitored to determine when the edited cells begin to produce mature blood cells, a process known as engraftment. After engraftment, patients will continue to be monitored to track the impact of CTX001 on multiple measures of disease and for safety.

About the CRISPR-Vertex Collaboration CRISPR Therapeutics and Vertex entered into a strategic research collaboration in 2015 focused on the use of CRISPR/Cas9 to discover and develop potential new treatments aimed at the underlying genetic causes of human disease. CTX001 represents the first potential treatment to emerge from the joint research program. CRISPR Therapeutics and Vertex will jointly develop and commercialize CTX001 and equally share all research and development costs and profits worldwide.

About CRISPR Therapeutics CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom. For more information, please visit http://www.crisprtx.com.

CRISPR Therapeutics Forward-Looking Statement This press release may contain a number of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, as well as statements regarding CRISPR Therapeutics expectations about any or all of the following: (i) the status of clinical trials (including, without limitation, the expected timing of data releases) related to product candidates under development by CRISPR Therapeutics and its collaborators, including expectations regarding the data and plans to present data at the annual ASH meeting and exposition; (ii) the expected benefits of CRISPR Therapeutics collaborations; and (iii) the therapeutic value, development, and commercial potential of CRISPR/Cas9 gene editing technologies and therapies. Without limiting the foregoing, the words believes, anticipates, plans, expects and similar expressions are intended to identify forward-looking statements. You are cautioned that forward-looking statements are inherently uncertain. Although CRISPR Therapeutics believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: the potential for initial and preliminary data from any clinical trial and initial data from a limited number of patients (as is the case with CTX001 at this time) not to be indicative of final trial results; the potential that CTX001 clinical trial results may not be favorable; the potential impacts due to the coronavirus pandemic, such as the timing and progress of clinical trials; that future competitive or other market factors may adversely affect the commercial potential for CTX001; uncertainties regarding the intellectual property protection for CRISPR Therapeutics technology and intellectual property belonging to third parties, and the outcome of proceedings (such as an interference, an opposition or a similar proceeding) involving all or any portion of such intellectual property; and those risks and uncertainties described under the heading "Risk Factors" in CRISPR Therapeutics most recent annual report on Form 10-K, quarterly report on Form 10-Q, and in any other subsequent filings made by CRISPR Therapeutics with the U.S. Securities and Exchange Commission, which are available on the SEC's website at http://www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. CRISPR Therapeutics disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

CRISPR THERAPEUTICS word mark and design logo and CTX001 are trademarks and registered trademarks of CRISPR Therapeutics AG. All other trademarks and registered trademarks are the property of their respective owners.

About Vertex Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) a rare, life-threatening genetic disease and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule medicines in other serious diseases where it has deep insight into causal human biology, including pain, alpha-1 antitrypsin deficiency and APOL1-mediated kidney diseases. In addition, Vertex has a rapidly expanding pipeline of genetic and cell therapies for diseases such as sickle cell disease, beta thalassemia, Duchenne muscular dystrophy and type 1 diabetes mellitus.

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 11 consecutive years on Science magazine's Top Employers list and a best place to work for LGBTQ equality by the Human Rights Campaign. For company updates and to learn more about Vertex's history of innovation, visit http://www.vrtx.com or follow us on Facebook, Twitter, LinkedIn, YouTube and Instagram.

Vertex Special Note Regarding Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding the expectations and plans to present data at the annual ASH meeting and exposition, the development, including expected timeline for development, and potential benefits of CTX001, our plans and expectations for our clinical trials and clinical trial sites, and the status of our clinical trials of our product candidates under development by us and our collaborators, including activities at the clinical trial sites and potential outcomes. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company's development programs, including its programs with its collaborators, may not support registration or further development of its compounds due to safety, efficacy or other reasons, and other risks listed under Risk Factors in Vertex's most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission and available through the company's website at http://www.vrtx.com. You should not place undue reliance on these statements or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

CRISPR Therapeutics Investor Contact: Susan Kim, +1 617-307-7503 susan.kim@crisprtx.com

CRISPR Therapeutics Media Contact: Rachel Eides WCG on behalf of CRISPR +1 617-337-4167 reides@wcgworld.com

Vertex Pharmaceuticals Incorporated Investors: Michael Partridge, +1 617-341-6108 or Zach Barber, +1 617-341-6470 or Brenda Eustace, +1 617-341-6187

Media: mediainfo@vrtx.com or U.S.: +1 617-341-6992 or Heather Nichols: +1 617-839-3607 or International: +44 20 3204 5275

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CRISPR/Cas9 Gene-Editing Therapy CTX001 for Severe Hemoglobinopathies Accepted for Plenary Presentation at the 62nd American Society of Hematology...

Actinium Announces Two Oral Presentations Featuring Data and Findings from the Phase 3 SIERRA Trial of Iomab-B at the 62nd American Society of…

NEW YORK, Nov. 4, 2020 /PRNewswire/ --Actinium Pharmaceuticals, Inc.,(NYSE AMERICAN: ATNM) ("Actinium") today announced that two abstracts on the Company's Antibody Radiation Conjugate (ARC) Iomab-B were accepted for oral presentations at the 2020 American Society of Hematology (ASH) annual meeting that is being held virtually December 5-8, 2020.

"This is an exciting fourth quarter for the company and we are honored to have multiple oral presentations at this year's ASH conference. Our 3 oral presentations and one poster presentation demonstrate the clinical progress we have seen not only with Iomab-B, but our other programs including Actimab-A in combination with novel and approved therapeutic agents," stated Sandesh Seth, Actinium's Chairman and CEO. "We look forward to presenting the Iomab-B data in further detail during the two oral presentations on the Iomab-B SIERRA study at ASH in December. The company remains on track to report safety and feasibility data from 75% of the patients to be enrolled in SIERRA, as well as to complete the ad hoc interim analysis in the fourth quarter."

Mark Berger, Actinium's Chief Medical officer, said, "We are encouraged that we continue to see positive ongoing results from our Phase 3 pivotal SIERRA trial in relapsed or refractory Acute Myeloid Leukemia (R/R AML) patients. In the Iomab-B Phase 3 trial we continue to see 100% engraftment in patients receiving a therapeutic dose of Iomab-B in the treatment arm whereas 83% of control arm patients failed salvage therapy, which includes the recently approved targeting agents such as venetoclax. This high failure rate demonstrates the significant need that exists in R/R AML and represents the paradigm shift we are looking to initiate with Iomab-B. The strong safety and feasibility data we have seen thus far gives us confidence that these older patients with active AML may benefit by undergoing a potentially curative bone marrow transplant which they could not receive otherwise."

Details & Highlights for Oral Presentations

Note: The two abstractsincludeSIERRA Phase 3 trial data available to the company from its CRO prior to August 10, 2020, the ASH submission cutoff date. Per ASH rules, updated data sets are permitted to be included in the live presentations.

OralPresentationTitle:

Personalized Targeted Radioimmunotherapy with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] in Patients with Active Relapsed or Refractory Acute Myeloid Leukemia Results in Successful Donor Hematopoietic Cells Engraftment with the Timing of Engraftment Not Related to the Radiation Dose Delivered

Publication Number:

193

Session Name:

721. Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities

Session Date:

Saturday, December 5, 2020

Presentation Time:

1:00 PM PT / 4:00 PM ET

Phase 3 SIERRA Preliminary Results

Baseline Characteristics

Randomized to Iomab-B (N=53)

Randomized to Conventional Care (CC) (N=53)

Age (yrs, median, range)

64 (55-77)

65 (55-77)

Molecular & Cytogenetic Risk

Favorable: 2% Intermediate: 33%

Adverse: 65%

Favorable: 4%

Intermediate: 30%

Adverse: 66%

% Transplanted Intent-to-Treat Group

87% (46/53)

17% (9/53)

59% (26/44)

Results

Received Therapeutic dose of Iomab-B & Transplanted (N=46)****

Eligible to Receive Std. of Care Transplant Post-Salvage (N=9)

Evaluated for Crossover (N=44)*****

Cross-over Rate

n/a

n/a

Received Therapeutic Dose of Iomab-B (N=26)

Transplanted (N=26)

59% (26/44)

% Transplanted

100% (46/46)

17% (9/53)

100% (26/26)

BM Blast % @ baseline (median, range)

26 (4-95)

14 (5-97)

30 (6-87)

BM Blast % pre-HCT (median, range)

26 (4-95)

1 (0-3)*

32.5 (2-75)

Days to ANC Engraftment

14 (9-22)***

17 (13-83)#

14 (10-37)**

Days to Platelet Engraftment

17 (4-39)***

22 (8-35)#

19 (1-38)**

Days to HCT (Post Randomization)

30 (23-60)

66 (51-86)

65 (36-161)^

Myeloablative Dose Delivered to Bone Marrow

14.7 (4.6-32) Gv

n/a

14.4 (6.3-30) Gv

540 (313-1008) mCi

632 (354-1027) mCi

Chimerism>/=95% by D100

91% (39/43^ Evaluable)

67% (4/6^^ Evaluable)

87% (20/23^^^ Evaluable)

100-day non-Relapse Transplant-Related Mortality

5% (2/40 Evaluable)

25% (2/8 Evaluable)

8% (2/24 Evaluable)

*1 pt with 8% BM blasts on D42 with CRp on D50, ** ANC engraftment data not available (N=3), platelet engraftment data not available (N=4); *** ANC engraftment data not available (N=4), platelet engraftment data not available (N=9), ^ 1 patient at 161 days had delayed transplant due to infection and respiratory failure, received Iomab & transplant when stable, # ANC and platelet engraftment data not available (N=2)

**** No Therapy Dose (7) due to: Declining KPS (4), Infusion Reaction (1), Unfavorable Biodistribution (1), Post-Randomization Eligibility (1); 1 Pending Treatment.

*****Ineligible for Iomab-B HCT after crossover evaluation - 13: due to Hospice Care/Progression (4), Declined/Ineligible for HCT (5), Died Pre-Crossover (4). 4 Received Dosimetry but No Therapy Dose due to Declining KPS; 2 Pending Evaluation for Crossover.

^ Did not achieve 95% chimerism (4); Data pending (2); Died (1); ^^ Did not achieve 95% chimerism (4); Data pending (1); ^^^Did not achieve 95% chimerism (4); Data pending (2);

Oral PresentationTitle:

High Doses of Targeted Radiation with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Do Not Correlate with Incidence of Mucositis, Febrile Neutropenia or Sepsis in the Prospective, Randomized Phase 3 Sierra Trial for Patients with Relapsed or Refractory Acute Myeloid Leukemia

Publication Number:

135

Session Name:

721. Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities

Session Date:

Saturday, December 5, 2020

Presentation Time:

9:30 AM PT / 12:30 PM ET

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Actinium Announces Two Oral Presentations Featuring Data and Findings from the Phase 3 SIERRA Trial of Iomab-B at the 62nd American Society of...

Gamida Cell Announces Data to Be Presented at 62nd ASH Annual Virtual Meeting – Business Wire

BOSTON--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, today announced that updated data from the ongoing Phase 1 clinical study of GDA-201, an investigational, natural killer (NK) cell-based cancer immunotherapy for the treatment of patients with non-Hodgkin lymphoma, will be presented in an oral presentation at the American Society of Hematology (ASH) 62nd Annual Meeting, which is being held virtually from December 5-8, 2020. NK cell immunotherapies are thought to offer tremendous potential for transforming the care of hematologic malignancies. Gamida Cell is pioneering a novel approach that harnesses the power of its cell expansion technology, which uniquely improves antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells.

Additionally, new data from the ongoing Phase 1/2 study of omidubicel in patients with severe aplastic anemia will be shared in a poster presentation during the meeting. Omidubicel is an investigational advanced cell therapy in development as a potential life-saving treatment option for patients in need of a bone marrow transplant.

Omidubicel is also being evaluated in a Phase 3 study in patients with hematologic malignancies. Earlier this year, Gamida Cell reported that its Phase 3 study of omidubicel met its primary endpoint, demonstrating a highly statistically significant reduction in time to neutrophil engraftment, a key milestone in recovery from a stem cell transplant. Last month, Gamida Cell also reported that all three secondary endpoints for the study demonstrated statistical significance. The secondary endpoints in the study include outcomes for: platelet engraftment, infections and hospitalizations.

Details about the ASH presentations are as follows:

Title: Results of a Phase 1 Trial of GDA-201, Nicotinamide-Expanded Allogeneic Natural Killer (NK) Cells in Patients with Refractory Non-Hodgkin Lymphoma (NHL) and Multiple Myeloma Abstract Number: 63 Lead Author: Veronika Bachanova, M.D., Ph.D., Division of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, MN Time: Saturday, December 5, 2020, 7:30 a.m. 9:00 a.m. PT (session time) and 7:30 a.m. PT (presentation)

Title: Rapid Engraftment, Immune Recovery, and Resolution of Transfusion Dependence in Treatment-Refractory Severe Aplastic Anemia Following Transplantation with Ex Vivo Expanded Umbilical Cord Blood (Omidubicel) Abstract Number: 1531 Lead Author: Mohamed Samour, M.D., Hematology Branch, National Heart, Lung, and Blood Institute, Bethesda, MD Time: Saturday, December 5, 2020, 7:00 a.m. 3:30 p.m. PT

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). In both Phase 1/2 and Phase 3 clinical studies (NCT01816230, NCT02730299), omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit http://www.clinicaltrials.gov.

Omidubicel is an investigational therapy, and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

About GDA-201

Gamida Cell applied the capabilities of its NAM-based cell expansion technology to develop GDA-201, an innate natural killer (NK) cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. GDA-201 is in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.1

GDA-201 is an investigational therapy, and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.

About Gamida Cell

Gamida Cell is an advanced cell therapy company committed to cures for patients with blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. For additional information, please visit http://www.gamida-cell.com or follow Gamida Cell on LinkedIn or Twitter at @GamidaCellTx.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the potential of NK cell immunotherapies and the continuation of Gamida Cells clinical programs, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to the scope and progress of Gamida Cells clinical trials and other clinical, scientific, regulatory and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of Gamida Cells public filing on Form 20-F, filed with the SEC on February 26, 2020, and other filings that Gamida Cell makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cells actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to Gamida Cell as of the date of this release.

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Gamida Cell Announces Data to Be Presented at 62nd ASH Annual Virtual Meeting - Business Wire

XNK Therapeutics receives US orphan drug status for NK cell-based immunotherapy in multiple myeloma – BioSpace

STOCKHOLM, Nov. 4, 2020 /PRNewswire/ --XNK Therapeutics AB ("XNK") today announced it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its leading investigational drug candidate in the treatment of multiple myeloma (MM).

Receiving ODD status from the FDA for the treatment of multiple myeloma is a critical next step for the development of XNK's leading investigational drug candidate. XNK has already received ODD status in the EU.

"Obtaining an ODD by the FDA is a significant milestone for XNK and our goal of taking the present drug candidate to the next level," said Johan Liwing, CEO of XNK Therapeutics. "This is the starting point for us to expand clinical development into the most important market globally for cancer treatment."

XNK has already completed its first-in-human Phase I/II clinical trial (ACP-001) in multiple myeloma at the Karolinska University Hospital in Stockholm, Sweden, showing a very good safety profile, and promising efficacy data. The company is continuing the clinical development in multiple myeloma in Europe and plans to initiate a Phase II clinical trial in the near future.

For more information, please contact:

Johan Liwing, CEO, XNK Therapeutics Tel: +46706 70 36 75 E-mail: johan.liwing@xnktherapeutics.com

About XNK Therapeutics AB

XNK Therapeutics is a clinical stage, immunotherapy company focusing its efforts on preventing and treating cancer by developing novel NK cell-based therapies. The company has established a leadership position in the clinical development and manufacture of autologousNK cell-based products using its proprietary technology platform. The company's platform technology and leading investigational drug candidate have ideal properties for targeting cancers, including settings where allogeneic cell products are not readily applicable. It is foreseen that the product will bring a critical component to tomorrow's cancer treatment strategies. XNK Therapeutics is headquartered in Stockholm, Sweden. For more info, please visit http://www.xnktherapeutics.com.

About XNK Therapeutics's technology platform

The platform has ideal properties to produce autologous NK cell-based drug candidates for targeting malignant diseases across a wide range of indications in mono- and combination therapy. It encompasses a unique closed manufacturing system for development of the NK cell-based products. The process includes a selective expansion and activation of NK cells from peripheral blood of patients with cancer. The product is produced in less than three weeks. It is delivered to the clinic upon need, where the product is thawed and infused into the patient without any further processing. The product has demonstrated an up to 10-year stability in liquid nitrogen. The assets of XNK Therapeutics are protected by patents in the US, Europe and certain other jurisdictions. Additional patent applications have been filed.

About Our Therapy

The leading drug candidate from XNK Therapeutics' technology platform was previously clinically tested in a first-in-human Phase I/II clinical trial (ACP-001). The study was performed at the Karolinska University Hospital, Stockholm, Sweden in a setting of consolidation treatment following high dose stem cell transplantation in patients newly diagnosed with multiple myeloma. The study was an open, single-arm, triple escalating dose/patient clinical trial with the primary objective of studying the product's safety and tolerability. In the study, the therapy showed a very good safety profile, and promising efficacy data. XNK Therapeutics is continuing its clinical development in multiple myeloma and plans to initiate a Phase II clinical trial in the near future.

About multiple myeloma

Multiple myeloma, the company's first target, is the third most frequent hematological malignancy worldwide. Multiple myeloma treatment has improved over the last two decades with the development and introduction of new agents leading to more effective treatments. Still, it remains a fatal disease in the majority of cases.

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/xnk-therapeutics-ab/r/xnk-therapeutics-receives-us-orphan-drug-status-for-nk-cell-based-immunotherapy-in-multiple-myeloma,c3231231

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Global Autologous Cell Therapy Market will Showcase Neutral Impact During 2020-2024 | Use of Biomass as a Fuel in Boiler to Boost Market Growth |…

LONDON--(BUSINESS WIRE)--Technavio has been monitoring the global autologous cell therapy market and it is poised to grow by USD 1.97 billion during 2020-2024, progressing at a CAGR of almost 22% during the forecast period. The report offers an up-to-date analysis regarding the current market scenario, latest trends and drivers, and the overall market environment.

Technavios in-depth research has all your needs covered as our research reports include all foreseeable market scenarios, including pre- & post-COVID-19 analysis. Download Latest Free Sample Report on COVID-19 Analysis

The market is fragmented, and the degree of fragmentation will accelerate during the forecast period. Bayer AG, Brainstorm Cell Therapeutics Inc., Daiichi Sankyo Co. Ltd., FUJIFILM Holdings Corp., Holostem Terapie Avanzate Srl, Osiris Therapeutics Inc., Takeda Pharmaceutical Co. Ltd., Teva Pharmaceutical Industries Ltd., Sumitomo Chemical Co. Ltd., and Vericel Corp. are some of the major market participants. To make the most of the opportunities, market vendors should focus more on the growth prospects in the fast-growing segments, while maintaining their positions in the slow-growing segments.

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The use of biomass as a fuel in boilers has been instrumental in driving the growth of the market.

Technavio's custom research reports offer detailed insights on the impact of COVID-19 at an industry level, a regional level, and subsequent supply chain operations. This customized report will also help clients keep up with new product launches in direct & indirect COVID-19 related markets, upcoming vaccines and pipeline analysis, and significant developments in vendor operations and government regulations. Download a Free Sample Report on COVID-19 Impacts

Autologous Cell Therapy Market 2020-2024: Segmentation

Autologous Cell Therapy Market is segmented as below:

Autologous Cell Therapy Market 2020-2024: Scope

Technavio presents a detailed picture of the market by the way of study, synthesis, and summation of data from multiple sources. The autologous cell therapy market report covers the following areas:

This study identifies the increasing demand for effective drugs for cardiac and degenerative disorders as one of the prime reasons driving the Autologous Cell Therapy Market growth during the next few years.

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Autologous Cell Therapy Market 2020-2024: Key Highlights

Table of Contents:

Executive Summary

Market Landscape

Market Sizing

Five Forces Analysis

Market Segmentation by Therapy

Customer landscape

Geographic Landscape

Drivers, Challenges, and Trends

Vendor Landscape

Vendors covered

Appendix

About Us

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Global Autologous Cell Therapy Market will Showcase Neutral Impact During 2020-2024 | Use of Biomass as a Fuel in Boiler to Boost Market Growth |...

Covid-19 Impact On Animal Stem Cell Therapy Market Analysis, Trends, Share, Size, Consumption 2020 2026 | MediVet Biologic, VETSTEM BIOPHARMA, J-ARM,…

Chicago, United States: Global Animal Stem Cell Therapy Market Report 2020, Forecast to 2026, The report focuses on encompassing several factors such as global distribution, manufacturers, and various regions. The report has summed up industry analysis size, share, application, and statistics associated with the global Peptide Synthesis market. The report delivers an in-depth competitive landscape, Growth opportunities, market share coupled with product type and applications. The report also estimates comprehensive market revenue along with Growth patterns, and the overall volume of the market.

Crucial information and forecast statistics covered in the Animal Stem Cell Therapy Market report will arm both existing and emerging market players with necessary insights to craft long-term strategies as well as maintain business continuity during a crisis such as the ongoing COVID-19 pandemic.

Key players covered in the report include: MediVet Biologic, VETSTEM BIOPHARMA, 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

Request for Sample Report (Including COVID19 Impact Analysis, full TOC, Tables and Figures) of Animal Stem Cell Therapy Market @ https://www.reporthive.com/request_sample/2470743

NOTE: Due to the pandemic, we have included a special section on the Impact of COVID 19 on the Animal Stem Cell Therapy Market which would mention How the Covid-19 is affecting the Animal Stem Cell Therapy Industry, Market Trends and Potential Opportunities in the COVID-19 Landscape, Covid-19 Impact on Key Regions and Proposal for Animal Stem Cell Therapy Players to Combat Covid-19 Impact. Valuable information covered in the Animal Stem Cell Therapy Market report has been segregated into key segments and sub-segments.

By Service type Dogs Horses Others

By End use Veterinary Hospitals Research Organizations

This report can be dispatched within 24-48 Hours.

Animal Stem Cell Therapy Market: Competition Analysis

The Report Hive Research study presents a comprehensive analysis of global, regional, and country-level players active in the Animal Stem Cell Therapy Market. Competitive information detailed in the Animal Stem Cell Therapy Market report has been based on innovative product launches, distribution channels, local networks, industrial penetration, production methods, and revenue generation of each market player.

Important Questions Answered in the Animal Stem Cell Therapy Market Report

Key Offerings of the Report

>>>>Get Full Customize Report @ https://www.reporthive.com/request_customization/2470743

Animal stem cell therapy is a usage of animals stem cell to treat a disease or disorder. The ability of stem cell is to divide and differentiate into a cell with specialized function useful for repairing body tissues damaged by injury or disease. The animal stem cell therapy process involves three steps which include collection of stem cell sample from animals and preparing the sample to concentrate the stem cells. Finally, the therapy includes transferring the stem cells into the injured site for treatment. Animal stem cell therapy increases the expectancy of life in animals with no side effects. It is available for the treatment of arthritis, degenerative joint disorders, tendon, and ligaments injuries in animals. Stem cell therapy is most often used to treat dogs, cats, and horses. But recent developments made it possible to use animal stem cell therapy in tiger, pig, etc. Present animal stem cell therapy is studied in treatments of the inflammatory bowel, kidney, liver, heart and immune-mediated diseases respectively. The global Animal Stem Cell Therapy market is expected to reach xxx Million USD by 2025, with a CAGR of xx% from 2020 to 2025.

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Covid-19 Impact On Animal Stem Cell Therapy Market Analysis, Trends, Share, Size, Consumption 2020 2026 | MediVet Biologic, VETSTEM BIOPHARMA, J-ARM,...

Animal Stem Cell Therapy Market Size 2020-2026 Review, Key Findings, Growth Strategy, Developing Technologies, Trends And Global Forecast By Regions -…

The Animal Stem Cell Therapy market report provides a detailed analysis of the emerging trends, opportunities, and as well as the challenges in the market. This extensive report sheds light on the latest developments, market drivers, and competitive analysis to help the new entrants and emerging players to make crucial decisions.

Besides this, the market research report presents insights on consumer behavior, regulatory policies, and supply & demand scenario to provide a holistic view of the market. The primitive aim of the report is to represent the critical data and figures of the market concisely and layout top winning strategies to aid industry players to leverage their market position.

Get Free Sample Report + All Related Graphs & Charts: https://industrygrowthinsights.com/request-sample/?reportId=171131

The dedicated research team has included Porters Five Point Force analysis to tailor the Global Animal Stem Cell Therapy Market. They have conducted interviews with industry experts to provide accurate predictions and better insights in a detailed manner. The research report covers the latest advancements that have overhauled the market dynamics while examined the threats which has impacted the overall market.

Key Answers Captured in the Study are

Complete Purchase of Latest Version Global Animal Stem Cell Therapy Market Study with COVID-19 Impact Analysis: https://industrygrowthinsights.com/checkout/?reportId=171131

Important Features that are under offering & key highlights of the report:

Detailed overview of Animal Stem Cell Therapy

Changing market dynamics of the industry

In-depth market segmentation by Type, Application, etc.

Historical, current, and projected market size in terms of volume and value

Recent industry trends and developments

Competitive landscape of Animal Stem Cell Therapy

Strategies of key players and product offerings

Potential and niche segments/regions exhibiting promising growth

A neutral perspective towards Animal Stem Cell Therapy performance

Market players information to sustain and enhance their footprint

Ask for the discount @ https://industrygrowthinsights.com/ask-for-discount/?reportId=171131

Research Objectives

To analyze and forecast the Worldwide Animal Stem Cell Therapy, in terms of value and volume.

Which segment has the potential to gain the highest market share?

To help decision-makers from a new offer perspective and benchmark existing marketing strategy.

Correlate cost structure historical data with key business segments.

Analyze marketing contribution and customer acquisition by up-selling and cross-selling.

Identifying Influencing factors keeping Worldwide Animal Stem Cell Therapy Intense, factored with periodic analysis of CR4 & CR8 concentration ratio & HHI Index.

Important Features that are under offering & key highlights of the report:

1) Does the study cover COVID-19 Impact Analysis and its effect on Growth %?

Yes, the overall industry has seen quite a big impact due to slowdown and shutdown in the production line & supply chain. The study covers a separate qualitative chapter on COVID-19 Impact analysis. Additionally, it also provides before and after the scenario of COVID-19 on sales growth & market size estimation to better analyze the exact scenario of the industry.

2) How companies are selected or profiled in the report?

List of some players that are profiled in the report include:

Medivet Biologics LLC VETSTEM BIOPHARMA J-ARM U.S. Stem Cell, Inc VetCell Therapeutics Celavet Inc. Magellan Stem Cells Kintaro Cells Power Animal Stem Care Animal Cell Therapies Cell Therapy Sciences Animacel

Usually, we follow NAICS Industry standards and validate company profile with product mapping to filter relevant Industry players, furthermore the list is sorted to come up with a sample size of at least 50 to 100 companies having greater topline value to get their segment revenue for market estimation.

** List of companies mentioned may vary in the final report subject to Name Change / Merger etc.

3) Can we add or profiled a new company as per our needs?

Yes, we can add or profile a new company as per client need in the report, provided it is available in our coverage list as mentioned in answer to Question 1 and after feasibility run, final confirmation will be provided by the research team checking the constraints related to the difficulty of survey.

4) Can we narrow the available business segments?

Yes, depending upon the data availability and feasibility check by our Research Analyst, a further breakdown in business segments by end-use application or product type can be provided (If applicable) by Revenue Size or Volume*.

Animal Stem Cell Therapy market segmentation

The Study is segmented by following Product Type:

Dogs Horses Others

Major applications/end-users industry are as follows:

Veterinary Hospitals Research Organizations

5) Can a specific country of interest be added? What all regional segmentation covered?

Yes, Country-level splits can be modified in the study as per objectives. Currently, the research report gives special attention and focus on the following regions:

North America [United States, Canada, Mexico], Asia-Pacific [China, India, Japan, South Korea, Australia, Indonesia, Malaysia, Philippines, Thailand, Vietnam], Europe [Germany, France, UK, Italy, Russia, Rest of Europe], South America [Brazil, Argentina, Rest of South America], Middle East & Africa [GCC Countries, Turkey, Egypt, South Africa, Rest of the Middle East & Africa]

** One country of specific interest can be included at no added cost. For inclusion of more regional segment quotes will vary.

Get on the call with our research analyst if you have any particular doubts before buying the report @ https://industrygrowthinsights.com/enquiry-before-buying/?reportId=171131

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Animal Stem Cell Therapy Market Size 2020-2026 Review, Key Findings, Growth Strategy, Developing Technologies, Trends And Global Forecast By Regions -...

U.S. elections bring wins and losses for research community – Science Magazine

An election worker in Pennsylvania prepares ballots for counting during yesterdays elections.

By Jeffrey Mervis, David MalakoffNov. 4, 2020 , 2:35 PM

Its not yet clear who will be the next U.S. president and which party will control the Senate. And although Democrats in the House of Representatives will remain in the majority in the next Congress, there was no blue wave. That last takeaway from yesterdays electionswith many votes still to be countedis not good news for several candidates and incumbents with science backgrounds and those holding influential positions on the House science committee.

Voters around the country also weighed in on more than 100 state ballot items, a few of which had drawn interest from the research community.

Among House races,Democrat Nancy Goroff, a Stony Brook University chemistry professor, is trailing badly in her bid to become the first female House member with a science Ph.D. Representative Lee Zeldin (RNY) is leading the race with about 60% of the vote, although the tally doesnt include tens of thousands of votes cast before 3 November. We owe it to voters that every single one be counted, Goroffs campaign manager, Jacob Sarkozi, said early this morning about a process that could take weeks.

Democrat Kathleen Williams, a water resource management expert from Montana, has been defeated by Republican Matt Rosendale, now state auditor. It was her second attempt at the at-large seat, and her 12-point loss was much larger than in 2018.

Democrat Cameron Webb, a physician and health care advocate, lost to Republican Robert Good for an open seat in a rural Virginia district. But Democrat Hiral Tipirneni, an emergency room physician, was narrowly ahead of Representative David Schweikert (RAZ) in a district outside of Phoenix, although the race was too close to call this morning. She lost her bid for a House seat in 2018.

Representative Joe Cunningham (DSC), an environmental engineer who was a surprise victor in 2018, failed to retain his seat, losing to Republican challenger Nancy Mace. His campaign touted his ability to cross the aisleand defy Democratic leaders at timesin a district that is strongly Republican.

Representative Lauren Underwood (DIL) is narrowly trailing state Senator Jim Oberweis. A health policy analyst whose 2018 victory made her the youngest Black woman in Congress, Underwood has strongly criticized the Trump administrations handling of the COVID-19 pandemic. Shes counting on the large number of ballots not yet counted to win a second term.

In contrast, a few rookie legislators with technical backgrounds will be returning. Representative Sean Casten (DIL)defeated Republican Jeanne Ives by a five-point margin. A biochemical engineer, Casten has madesustainable energy a key element in his platform. Representative Elaine Luria (DVA), a nuclear engineer, is leading a former House member, Scott Taylor, by a similar margin that is expected to widen once the count is completed. Representative Kim Schrier (DWA), a pediatrician, also has a comfortable lead over Republican challenger Jesse Jensen.

Despite Democrats retaining control of the House, there is likely to be a reshuffling of leadership positions on the Committee on Science, Space, and Technology, which has the broadest mandate over the U.S. research enterprise. Representative Eddie Bernice Johnson (DTX) will remain chairwoman after another easy victory, and Representative Frank Lucas (ROK) is expected to continue as the top Republican. But freshman Representative Kendra Horn (DOK), who chairs the space subcommittee, lost her bid for reelection. And Representative Haley Stevens (DMI), who chairs the research panel, is trailing Republican challenger Eric Esshaki.

The only Ph.D. physicist in Congress, Representative Bill Foster (DIL), has won a fifth 2-year term by a comfortable margin. He now chairs the panels investigations subcommittee. Two other subcommittee chairs, both first-time legislators, will also be returning. Representative Lizzie Fletcher (DTX) now chairs the energy panel, and Representative Mikie Sherrill (DNJ) leads the environmental panel.

In the Senate, a leading advocate for research has been toppled, while another is struggling to retain his seat. Senator Cory Gardner (RCO) lost to Democrat John Hickenlooper, while Senator Gary Peters (DMI) had a narrow lead this morning against Republican challenger John James. In 2017, as members of the Senate Commerce, Science, and Transportation Commmittee, Gardner and Peters led a successful bipartisan effort to reauthorize a slew of research programs across several federal agencies. That committee is chaired by Senator Roger Wicker (RMS), who easily won reelection in 2018 for a third 6-year term.

In Wyoming, ecologist Merav Ben-David, a Democrat, lost her long-shot bid for a Senate seat. The state has not elected a Democrat to federal office since 1976. Former Representative Cynthia Lummis seized the Senate seat with 73% of the vote.

California voters appear to favor a proposition that would allow the state to sell $5.5 billion in bonds to provide a second round of funding for the California Institute for Regenerative Medicine, which conducts work with human embryonic stem cells. In partial returns, yes votes on Proposition 14 outweighed nos51.1% to 48.9%. Proponents of the measure raised nearly $17 million, but editorials in several major newspapers argued the state shouldnt take on new debt during a time of economic hardship.

In Colorado, the fate of a plan to allow the state to reintroduce gray wolves was unclear. With about 85% of ballots counted, supporters of Proposition 114 had a 50.2% to 49.8% lead.

Oregon voters appear to have approved Measure 109, which would legalize the clinical use of edible fungi that contain psilocybin, which causes people to experience euphoria and hallucinations. With more than 80% of ballots counted, supporters of the measure have a 55.8% to 44.2% lead. If that lead holds, Oregon will become the first state to allow the use of so-called magic mushrooms in clinical research settings. (Possession of the fungi, which is illegal under federal law, has already been decriminalized in several cities; Washington D.C., voted yesterday to make possession of such substances among the lowest law enforcement priorities.)

Nevada appears to have approved Question 6, which would require utilities to double, to 50%, the amount of energy they obtain from renewable sources by 2030. With nearly 80% of ballots counted, supporters led opponents by 56.4% to 43.6%. This is the second time Nevada voters have approved the constitutional mandate, which by statute must be approved in two even-numbered election years to become law. Many experts expect utilities to lean heavily on solar power to meet the mandate.

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U.S. elections bring wins and losses for research community - Science Magazine