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J&J Reaches Opioid Settlement Agreement with New York State Consistent with Terms of Previously…
Johnson & Johnson and its U.S.-based Janssen Pharmaceutical Companies announced a settlement agreement with the State of New York and its participating subdivisions, including…
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FDA accepts application for Roche’s Port Delivery System with ranibizumab (PDS) for treatment of…
Roche announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for Port Delivery System with…
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FDA Approves StrataGraft for the Treatment of Adults with Thermal Burns
Today, the U.S. Food and Drug Administration approved StrataGraft for the treatment of adult patients with thermal burns containing intact dermal elements (remaining deep skin layers)…
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GSK and iTeos Therapeutics announce development and commercialisation collaboration for EOS-448, an…
GlaxoSmithKline plc and iTeos Therapeutics announced an agreement to co-develop and co-commercialise EOS-448, an anti-TIGIT monoclonal antibody currently in phase I development as a…
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Merck Announces Supply Agreement with U.S. Government for Molnupiravir, an Investigational Oral…
Merck, known as MSD outside the United States and Canada, today announced it has entered into a procurement agreement with the United States government for molnupiravir (MK-4482).…
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Merck Announces Completion of Organon & Co. Spinoff
Merck known as MSD outside the United States and Canada, announced it has completed the spinoff of Organon & Co. (Organon).
“Today marks a significant milestone for both Merck…
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Samsung Biologics to add mRNA vaccine drug substance manufacturing suite to expand portfolio of…
Samsung Biologics announced its plans to add mRNA vaccine drug substance (DS) manufacturing capability to the current facility in Songdo, ready for cGMP operations within the earlier…
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Novartis and Molecular Partners announce start of EMPATHY clinical trial for ensovibep for the…
Novartis and Molecular Partners announced the start of the clinical trial EMPATHY, a Phase 2 and 3 study, to explore the use of its novel DARPin therapeutic candidate ensovibep (MP0420)…
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Thermo Fisher Scientific and University of California, San Francisco to Open Cell Therapy cGMP…
Thermo Fisher Scientific Inc. the world leader in serving science, and the University of California, San Francisco (UCSF) announced they have formed a strategic alliance to accelerate…
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Pfizer Acquires Amplyx Pharmaceuticals
Pfizer Inc. announced that it has acquired Amplyx Pharmaceuticals, Inc., a privately-held company dedicated to the development of therapies for debilitating and life-threatening…
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Sanofi to help manufacture Moderna COVID-19 vaccine, supporting global supply demands
Sanofi has entered into an agreement with Moderna, under which Sanofi will help manufacture Moderna´s COVID-19 vaccine, supporting the COVID-19 pandemic and vaccine supply needs.…
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GSK and Vir Biotechnology announce EMA review of dual-action monoclonal antibody VIR-7831 for the…
GSK and Vir continue discussions with global regulators to make VIR-7831 available to patients with COVID-19.
GlaxoSmithKline plc and Vir Biotechnology, Inc. announced that the…
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FDA Grants Accelerated Approval to Trodelvy for the Treatment of Metastatic Urothelial Cancer
Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Trodelvy (sacituzumab govitecan-hziy) for use in adult patients with…
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Sanofi acquires Tidal Therapeutics
Sanofi acquired Tidal Therapeutics, a privately owned, pre-clinical stage biotech company with a novel mRNA-based approach for in vivo reprogramming of immune cells. The new technology…
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AstraZeneca to supply the US with up to half a million additional doses of the potential COVID-19…
AstraZeneca has modified an existing agreement with the US Government to supply up to 500,000 additional doses of AZD7442, a long-acting antibody (LAAB) combination which is in…
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UCB and Microsoft Expand Collaboration to Accelerate Drug Discovery and Development
UCB and Microsoft have announced a new multi-year, strategic collaboration to combine Microsoft's computational services, cloud, and artificial intelligence (AI) with UCB's drug…
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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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