The latest news from the global pharmaceutical industry. Below you will find news and information to keep you up-to-date with what is happening in your industry. Coverage includes regulatory approvals, recall announcements, mergers and acquisitions, personnel news and appointments, new facility and facility expansion updates, collaborations and agreements, and financial updates.
FDA’s Clinical Methodologies Group (ClinMeth) received a $9.2 million grant through the HHS Office of the Assistant Secretary for Planning and ...
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Arecor Limited, a biopharmaceutical company, announced that it has signed a formulation study partnership with Eli Lilly and Company (“Lilly”), an ...
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The FDA published a new batch of product-specific guidelines (PSGs). PSGs provide recommendations for developing generic drugs and generating the ...
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Merck has announced that V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, met its primary immunogenicity and safety ...
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Takeda Pharmaceutical Company Limited announced that the U.S. Food & Drug Administration (FDA) has accepted a New Drug Application (NDA) for maribavir...
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The U.S. FDA approved Rybrevant as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic ...
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Janssen, the Pharmaceutical Companies of Johnson & Johnson, announced that the European Commission (EC) has approved PONVORY™ (ponesimod) for the ...
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Merck announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion ...
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Dicerna Pharmaceuticals, Inc. (the Company or Dicerna), a leading developer of investigational ribonucleic acid interference (RNAi) therapeutics, ...
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The U.S. FDA issued a final guidance on Bispecific Antibody Development Programs. This final guidance provides recommendations for industry and other ...
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Results of Early Trial Demonstrate 70% Overall Response Rate (ORR) in Patients with KRAS Mutant Tumors, 44% ORR in KRAS Wild-Type Tumors and 52% ORR ...
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Pfizer announced that the first enrolled subjects have received their immunizations as part of a new study in adults ages 65 or older exploring the ...
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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® ...
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The U.S. FDA is restricting the use of the liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis (PBC) with...
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Hoffmann-La Roche Limited (Roche Canada) announces a joint initiative with BC Cancer and the Canadian Personalized Healthcare Innovation Network (...
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