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Zhongsheng Pharmaceutical Initiates Phase II Trials for Polypeptide Drug RAY1225 in Diabetes and Obesity
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Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a Chinese pharmaceutical company, has announced the initiation of two Phase II clinical studies, SHINING and REBUILDING, for its Category 1 innovative polypeptide drug candidate RAY1225. These studies aim to assess the efficacy of RAY1225 as a treatment for type 2 diabetes and…
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AstraZeneca Secures Shareholder Approval for $1 Billion Acquisition of Gracell Biotechnologies
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The proposed acquisition of China-based Gracell Biotechnologies Inc. (Nasdaq: GRCL) by UK pharmaceuticals giant AstraZeneca (AZ, NASDAQ: AZN) has received approval from Gracell’s shareholders during an extraordinary general meeting held on February 19, 2024. An overwhelming 99.9% of shareholders voted in favor of AstraZeneca’s $1 billion acquisition, with potential total…
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FDA Issues Warning Letter to Sichuan Deebio for cGMP Violations in API Manufacturing
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The U.S. Food and Drug Administration (FDA) has issued a warning letter to Sichuan Deebio Pharmaceutical Co., Ltd., a China-based active pharmaceutical ingredient (API) manufacturer, following an on-site inspection that revealed significant deviations from current Good Manufacturing Practice (cGMP) standards. The FDA’s letter underscores Deebio’s shortcomings in properly documenting laboratory…
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Bayer Advances BAY3018250 into Phase II Trial Following Successful Phase I Completion
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Germany’s Bayer (ETR: BAYN) has launched a double-blind, placebo-controlled mid-stage trial for its potential first-in-class anti-alpha2 antiplasmin (anti-α2ap) drug, BAY3018250, aimed at treating symptomatic proximal deep vein thrombosis (DVT). This advancement comes on the heels of a successful Phase I study. The investigational antibody works by modulating the breakdown of…
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BMS Seeks FDA Priority Review for Krazati in Advanced Colorectal Cancer
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Bristol Myers Squibb (BMS; NYSE: BMY) has submitted a priority review application to the U.S. Food and Drug Administration (FDA) for an additional indication of its KRASG12C inhibitor, Krazati (adagrasib), in combination with cetuximab (Merck’s Erbitux) for pre-treated patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC). The FDA…
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WuXi ATU’s Philadelphia Facility Approved for Amtagvi Production Following FDA Nod
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WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec (SHA: 603259, HKG: 2359) based in China, has announced the U.S. FDA’s approval of its Philadelphia facility to commence analytical testing and manufacturing of Amtagvi (lifileucel) for Iovance. This novel therapy received accelerated approval for its Biologics License…
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HitGen’s Vernalis Partners with Hox Therapeutics to Develop Novel Cancer Inhibitors
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HitGen Inc. (SHA: 688222), based in China, announced that its wholly owned subsidiary Vernalis (R&D) Ltd will collaborate with Hox Therapeutics Ltd, a private biotech firm dedicated to developing highly targeted cancer therapies, to create inhibitors aimed at undisclosed targets. Vernalis will leverage its advanced protein science capabilities and Hit…
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Merck’s Keytruda Under Priority Review for New Indication in Endometrial Carcinoma
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This week, the U.S. FDA granted priority review status to an indication extension filing from Merck, Sharp & Dohme (MSD; NYSE: MRK) for its blockbuster drug Keytruda (pembrolizumab), seeking approval as a treatment for primary advanced or recurrent endometrial carcinoma, the most prevalent gynecological cancer. The FDA anticipates reaching a…
