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Forxiga approved in China for heart failure
AstraZeneca’s Forxiga (dapagliflozin) has been approved in China to reduce the risk of cardiovascular (CV) death and hospitalisation for heart failure (hHF) in adults with heart failure…
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Novartis ligelizumab (QGE031) receives FDA Breakthrough Therapy designation for patients with…
Novartis announced that the U.S. Food and Drug Administration (FDA) has granted ligelizumab (QGE031) Breakthrough Therapy designation for the treatment of chronic spontaneous urticaria…
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Rocket Pharmaceuticals Announces Buildout of R&D and Manufacturing Facility to Support…
Rocket Pharmaceuticals, Inc. a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, today announces the Company’s…
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Merck Acquires AmpTec to Expand mRNA Capabilities for Vaccines, Treatments and Diagnostics
Merck, a leading science and technology company, today announced the acquisition of AmpTec, a leading Hamburg, Germany-based, mRNA contract development and manufacturing organization…
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FDA approves GSK’s BENLYSTA as the first medicine for adult patients with active lupus nephritis in…
GlaxoSmithKline plc announced the US Food and Drug Administration (FDA) has approved BENLYSTA (belimumab) for the treatment of adult patients with active lupus nephritis (LN) who are…
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Lilly Announces Agreement to Acquire Prevail Therapeutics
Eli Lilly and Company and Prevail Therapeutics Inc. announced a definitive agreement for Lilly to acquire Prevail for $22.50 per share in cash (or an aggregate of approximately $880…
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Pfizer and BioNTech Receive FDA Advisory Committee Vote Supporting Potential First Emergency Use…
Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 4 in support of…
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Boehringer Ingelheim to Acquire Labor Dr. Merk & Kollegen to Strengthen its Next Generation…
Boehringer Ingelheim announced the execution of the agreement on the acquisition of Labor Dr. Merk & Kollegen. The acquisition will enable Boehringer Ingelheim to further expand and…
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Bayer and Atara Biotherapeutics Enter Strategic Collaboration for Mesothelin-Targeted CAR T-cell…
Bayer and Atara Biotherapeutics, Inc. announced an exclusive worldwide license agreement and research, development and manufacturing collaboration for mesothelin-directed CAR T-cell…
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Baricitinib Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized…
Eli Lilly and Company and Incyte announced that the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the distribution and emergency use of…
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Pfizer and BioNTech Reach an Agreement to Supply the EU With 200 Million Doses of Their BNT162b2…
Pfizer and BioNTech SE announced that they have reached an agreement with the European Commission to supply 200 million doses of their investigational BNT162b2 mRNA-based vaccine…
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FDA Authorizes Monoclonal Antibody for Treatment of COVID-19
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of…
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Merck to Acquire VelosBio
Merck, known as MSD outside the United States and Canada, and VelosBio Inc. announced that the companies have entered into a definitive agreement pursuant to which Merck, through a…
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Bayer acquires Asklepios BioPharmaceutical to broaden innovation base in cell and gene therapy
Bayer AG announced the acquisition of Asklepios BioPharmaceutical, Inc. (AskBio), a US-headquartered biopharmaceutical company specialized in the research, development and manufacturing…
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Roche And Prothena Will Advance Prasinezumab Into Late-Stage Clinical Development Study In…
Prothena Corporation plc a late-stage clinical company with expertise in protein dysregulation and a diverse pipeline of investigational therapeutics for neurodegenerative and rare…
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BioNTech and Pfizer Initiate Rolling Submission to European Medicines Agency for SARS-CoV-2 Vaccine…
Pfizer Inc. and BioNTech SE announced the initiation of a rolling submission to the European Medicines Agency (EMA) for BNT162b2, the lead candidate from the companies’ vaccine…
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Bristol Myers Squibb to Acquire MyoKardia for $13.1 Billion in Cash
Bristol Myers Squibb and MyoKardia, Inc. announced a definitive merger agreement under which Bristol Myers Squibb will acquire MyoKardia for $13.1 billion, or $225.00 per share in cash.…
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Pfizer Receives FDA Fast Track Designation for Duchenne Muscular Dystrophy Investigational Gene…
Pfizer Inc. announced that its investigational gene therapy candidate (PF-06939926) being developed to treat Duchenne muscular dystrophy (DMD) received Fast Track designation from the…
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FDA approves Nucala as the first and only biologic treatment for Hypereosinophilic Syndrome (HES)
GlaxoSmithKline plc (GSK) announced the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) for the treatment of adult and paediatric patients aged 12 years and…
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Jyseleca (Filgotinib) Approved in Japan for Rheumatoid Arthritis
Gilead Sciences, Inc. and Eisai Co., Ltd. announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted Gilead K.K. (Tokyo, Japan) regulatory approval of…
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