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Solid Biosciences Earns FDA Fast Track for SGT-501 Gene Therapy in CPVT
Solid Biosciences Inc., a clinical-stage company focused on genetic medicines for neuromuscular and cardiac diseases, announced it has received Fast Track designation from the U.S. Food…
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Gefurulimab Shows Significant Improvement in Daily Function for gMG Patients in Phase III PREVAIL…
A new potential treatment for generalised myasthenia gravis (gMG), a rare and debilitating autoimmune neuromuscular disease, has shown promising results in a large international…
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Sanofi to Acquire Vicebio, Boosting Respiratory Vaccine Portfolio
Sanofi has announced an agreement to acquire London-based biotechnology company Vicebio Ltd, expanding its presence in the respiratory vaccine space. The deal brings with it a promising…
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AstraZeneca to Invest $50 Billion in U.S. for Drug Manufacturing and R&D
AstraZeneca announces $50 billion of investment in the United States by 2030, building on America’s global leadership in medicines manufacturing and R&D. This investment is expected…
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Astellas Partners with Korea’s KISED to Support Drug-Discovery Startups
Astellas Pharma Inc. announced the signing of a memorandum of understanding (MoU) with the Korea Institute of Startup and Entrepreneurship Development (KISED), a government-backed…
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ENHERTU Plus Pertuzumab Granted U.S. Breakthrough Therapy Status for HER2+ Metastatic Breast Cancer
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to ENHERTU (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab for the…
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Sanofi’s SAR446597 Granted FDA Fast Track for Geographic Atrophy in AMD
The U.S. Food and Drug Administration (FDA) has granted fast track designation to SAR446597, a one-time intravitreal gene therapy developed by Sanofi for the treatment of geographic…
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FDA Approves GSK’s Shingrix in Prefilled Syringe Format
GSK announced that the U.S. Food and Drug Administration (FDA) has approved a new prefilled syringe presentation of Shingrix, the company’s vaccine for the prevention of shingles…
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Boehringer Ingelheim and LEO Pharma Partner to Commercialize and Develop SPEVIGO
Boehringer Ingelheim and LEO Pharma have entered an exclusive global license and transfer agreement to commercialize and further develop SPEVIGO (spesolimab), a monoclonal antibody…
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Merck to Acquire Verona Pharma, Adding First-in-Class COPD Drug Ohtuvayre to Pipeline
Merck, known as MSD outside the U.S. and Canada, announced that it will acquire Verona Pharma plc in a $10 billion deal, strengthening its presence in the respiratory disease space. The…
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AbbVie and IGI Ink Global Deal for First-in-Class Trispecific Antibody ISB 2001
AbbVie and IGI Therapeutics SA, a wholly owned subsidiary of New York-based Ichnos Glenmark Innovation, Inc. (IGI),announced an exclusive licensing agreement for IGI's lead…
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GSK Completes Acquisition of Efimosfermin to Combat Steatotic Liver Disease
GSK plc has finalized its acquisition of efimosfermin alfa from Boston Pharmaceuticals, a promising investigational therapy targeting steatotic liver disease (SLD). Efimosfermin is a…
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FDA Grants Priority Review for WINREVAIR Label Update Following ZENITH Trial Results
Merck, known as MSD outside the U.S. and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to a supplemental Biologics License…
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Lynozyfic (linvoseltamab-gcpt) Granted FDA Accelerated Approval for Relapsed/Refractory Multiple…
Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic (linvoseltamab-gcpt) to treat adult patients…
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Vetter Breaks Ground on New Clinical Site
Vetter, a leading, globally operating Contract Development and Manufacturing Organization (CDMO), celebrated the start of construction for its new clinical manufacturing site in Des…
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AbbVie to Acquire Capstan Therapeutics, Advancing Immunology Innovation
AbbVie and Capstan Therapeutics, Inc. announced a definitive agreement under which AbbVie will acquire Capstan, including CPTX2309, a potential first-in-class in vivo tLNP anti-CD19…
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Novartis Completes Acquisition of Regulus Therapeutics
Novartis has officially completed its acquisition of Regulus Therapeutics Inc., solidifying its strategic focus on advancing treatments for renal diseases. With the closing of the deal,…
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Gilead and Kymera Partner on Novel Oral CDK2 Degraders in Exclusive License Deal
Gilead Sciences, Inc. and Kymera Therapeutics, Inc. have announced an exclusive option and license agreement aimed at advancing a novel class of cancer treatments: molecular glue…
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FDA Approves Updated Label for Lilly’s Amyvid to Aid Alzheimer’s Diagnosis
Eli Lilly and Company announced that the U.S. FDA has approved a label update for Amyvid (florbetapir F 18 injection) for intravenous use. Amyvid is used for brain imaging to estimate…
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Novo Nordisk’s Ozempic Recommended by EU for Peripheral Arterial Disease in Type 2 Diabetes
Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion to update the label of Ozempic…
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