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Roche’s Giredestrant Shows Significant Progression-Free Survival Benefit in Phase III ER-Positive…
Roche has announced positive results from the Phase III evERA study evaluating giredestrant combined with everolimus in patients with estrogen receptor (ER)-positive, HER2-negative,…
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Roche to Acquire 89bio in Merger Deal, Gaining Phase 3 MASH Therapy Candidate
Roche announced that it has entered into a definitive agreement to acquire 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company developing innovative therapies for…
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GSK to Invest $30 Billion in U.S. R&D and Manufacturing Over Next 5 Years
GSK plc announced plans to invest $30 billion in the United States over the next five years, focusing on research and development and supply chain infrastructure. This major investment…
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FDA Grants Breakthrough Therapy Designation to Raludotatug Deruxtecan for CDH6-Positive…
Raludotatug deruxtecan (R-DXd), a novel CDH6-targeted antibody-drug conjugate developed by Daiichi Sankyo and Merck, has received Breakthrough Therapy Designation (BTD) from the U.S.…
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EU Approves Novo Nordisk’s Oral Semaglutide as First GLP-1 Pill to Cut Heart Risks
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved an update to the label of Novo Nordisk’s oral diabetes drug Rybelsus (oral…
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Tzield Approved in China as First Disease-Modifying Therapy for Stage 2 Type 1 Diabetes
The Chinese National Medical Products Administration (NMPA) has approved Tzield (teplizumab) as the country’s first disease-modifying therapy for autoimmune type 1 diabetes (T1D). The…
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CAPVAXIVE Shows Strong Immune Response in At-Risk Children and Teens
Merck, known as MSD outside the U.S. and Canada, announced positive results from its Phase 3 STRIDE-13 trial evaluating CAPVAXIVE, its 21-valent pneumococcal conjugate vaccine, in…
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Novartis to Acquire Tourmaline Bio, Boosting Cardiovascular Pipeline with Pacibekitug for ASCVD…
Novartis announced it has agreed to acquire Tourmaline Bio, a clinical-stage biopharmaceutical company focused on developing pacibekitug, an anti-IL-6 monoclonal antibody designed to…
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Health Canada Approves ELAHERE for Platinum-Resistant Ovarian Cancer
AbbVie announced that Health Canada has approved ELAHERE® (mirvetuximab soravtansine for injection) under the Priority Review process. ELAHERE is an antibody-drug conjugate (ADC)…
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Gilead Partners with PEPFAR to Provide Twice-Yearly HIV Prevention to 2 Million People in Low-Income…
Gilead Sciences, Inc. announced a partnership with the U.S. State Department and the United States President’s Emergency Plan for AIDS Relief (PEPFAR) to deliver lenacapavir—Gilead's…
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Amgen to Invest Over $600 Million in New Science and Innovation Center at U.S. Headquarters
Amgen has announced plans to invest more than $600 million in a cutting-edge center for science and innovation at its global headquarters in Thousand Oaks, California. The new facility…
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Boehringer’s HERNEXEOS Approved in China as First Oral Targeted Therapy for HER2-Mutant Advanced…
Boehringer Ingelheim announced that its drug HERNEXEOS (zongertinib tablets) has received approval from China’s National Medical Products Administration (NMPA) as a monotherapy…
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Novartis’ Leqvio Achieves Early LDL-C Goals with Less Muscle Pain
Novartis has announced encouraging results from its Phase IV V-DIFFERENCE study, which evaluated Leqvio (inclisiran) in patients with high cholesterol who had not met…
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RINVOQ Receives Health Canada Approval for Giant Cell Arteritis in Adults
AbbVie announced that Health Canada has granted a Notice of Compliance (NOC) for RINVOQ (upadacitinib) for the treatment of adults with giant cell arteritis (GCA). The approval includes…
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DATROWAY Approved in China for Previously Treated HR+/HER2- Metastatic Breast Cancer
China’s National Medical Products Administration (NMPA) has approved DATROWAY (datopotamab deruxtecan) for the treatment of adults with unresectable or metastatic hormone receptor (HR)…
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Genentech and Roche Break Ground on New Manufacturing Facility in North Carolina
Genentech, a member of the Roche Group, officially broke ground on its newest U.S. manufacturing site in Holly Springs, North Carolina, marking a major milestone as the biotech giant…
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AbbVie to Acquire Gilgamesh’s Bretisilocin, Boosting Psychiatry Pipeline for Depression
AbbVie and Gilgamesh Pharmaceuticals have entered into a definitive agreement under which AbbVie will acquire Gilgamesh’s lead investigational candidate, bretisilocin, a next-generation…
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Lilly’s Oral GLP-1, Orforglipron, Succeeds in Third Phase 3 Trial, Paving Way for Global Obesity…
Eli Lilly and Company announced that its investigational oral GLP-1 receptor agonist, orforglipron, delivered significant weight loss and blood sugar control in a Phase 3 clinical trial…
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Kite to Acquire Interius BioTherapeutics to Expand In Vivo Cell Therapy Capabilities
Kite, a Gilead Company, announced it will acquire Interius BioTherapeutics, a privately held biotech firm pioneering in vivo CAR therapies, in a $350 million deal aimed at advancing…
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Johnson & Johnson Invests $2B in New State-of-the-Art Manufacturing Facility in North Carolina
Johnson & Johnson has announced a major expansion of its U.S. manufacturing capabilities with a $2 billion, 10-year investment in a new 160,000+ square foot facility at FUJIFILM’s…
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