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FDA Grants Priority Review to Takeda Narcolepsy Drug
Takeda has taken a major step toward introducing a novel treatment for narcolepsy type 1 after the U.S. Food and Drug Administration accepted its New Drug Application and granted…
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Eisai, Henlius Partner to Bring Serplulimab to Japan
Eisai Co., Ltd. and Shanghai Henlius Biotech have signed an exclusive commercialization and co-exclusive development and manufacturing licensing agreement for the anti-PD-1 antibody…
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Genentech Licenses SanegeneBio RNAi Therapy in $1.5B Deal
SanegeneBio has entered a global licensing agreement with Genentech, part of the Roche Group, granting the pharmaceutical company exclusive worldwide rights to develop and commercialize…
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AstraZeneca, CSPC Partner on Next-Generation Obesity Therapies
AstraZeneca has strengthened its weight management and metabolic disease pipeline through a new strategic collaboration with CSPC Pharmaceuticals, targeting the development of multiple…
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AstraZeneca Pledges $15bn to Expand China R&D, Manufacturing
AstraZeneca has announced a landmark $15 billion investment in China through 2030, significantly expanding its research, development, and manufacturing capabilities as part of its…
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EMA Panel Backs Rezurock for Hard-to-Treat Chronic GVHD
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending conditional marketing authorisation for Rezurock…
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Simcere, Boehringer Partner on Bispecific Antibody for IBD Treatment
Simcere Pharmaceutical Group Ltd. and Boehringer Ingelheim have entered into a global license and collaboration agreement to develop SIM0709, a pre-clinical bispecific antibody designed…
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FDA Reviews Weekly Subcutaneous Dosing Option for Eisai’s Alzheimer’s Drug
Eisai Co., Ltd. and Biogen Inc. have announced a key regulatory milestone for their Alzheimer’s disease therapy lecanemab-irmb, marketed in the United States as LEQEMBI®. The U.S. Food…
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China Approves ENHERTU for Second-Line HER2-Positive Gastric Cancer
China’s National Medical Products Administration (NMPA) has approved ENHERTU® (trastuzumab deruxtecan) for the treatment of adult patients with locally advanced or metastatic…
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Charles River and Gazi University Partner on Gene Therapy Development
Charles River Laboratories International and Gazi University Faculty of Medicine have entered into a strategic collaboration aimed at advancing gene therapy research for rare genetic…
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Novo Nordisk and Aspect Deepen Cell Therapy Alliance in Diabetes
Novo Nordisk and Aspect Biosystems have announced the expansion of their strategic partnership, entering a new phase focused on developing advanced cellular medicines for diabetes that…
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BMS and Microsoft Partner to Advance AI-Based Lung Cancer Detection
Bristol Myers Squibb (BMS) has entered into a strategic collaboration with Microsoft to accelerate the early detection of lung cancer by integrating advanced artificial intelligence…
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Novartis Licenses SciNeuro’s Brain-Targeting Alzheimer’s Antibody Program
SciNeuro Pharmaceuticals has entered into a worldwide licensing and collaboration agreement with Novartis Pharma AG to advance a novel antibody program for the treatment of Alzheimer’s…
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AbbVie to Acquire West’s Arizona Device Manufacturing Facility
AbbVie and West Pharmaceutical Services have announced a definitive agreement under which AbbVie will acquire a device manufacturing facility and associated intellectual property from…
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Solid Biosciences Advances Gene Therapy for Friedreich’s Ataxia
Solid Biosciences Inc., a life sciences company focused on developing precision genetic medicines for neuromuscular and cardiac diseases, has reached two important milestones in the…
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GSK Phase III Trials Show Promise for Chronic Hepatitis B Therapy
GSK plc has reported positive results from two pivotal phase III clinical trials evaluating bepirovirsen, an investigational antisense oligonucleotide therapy for chronic hepatitis B…
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Takeda Expands Entyvio Options Through Halozyme Technology Partnership
Takeda Pharmaceutical Company has entered into a global collaboration and license agreement with Halozyme Therapeutics to use Halozyme’s proprietary ENHANZE® drug delivery technology…
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FDA Grants Priority Review for Tzield Pediatric Indication Expansion
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental biologic license application (sBLA) for Tzield (teplizumab-mzwv), a therapy designed to delay…
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Takeda, Protagonist File NDA for Rusfertide in Polycythemia Vera
Takeda and Protagonist Therapeutics have submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of rusfertide for the treatment of adults…
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FDA Approves GSK’s Twice-Yearly Biologic for Severe Eosinophilic Asthma
GSK has received U.S. Food and Drug Administration approval for Exdensur (depemokimab-ulaa), a new add-on maintenance treatment for patients aged 12 years and older with severe asthma…
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