FDA Issues Warning Letter to Sichuan Deebio for cGMP Violations in API Manufacturing
The U.S. Food and Drug Administration (FDA) has issued a warning letter to Sichuan Deebio...
Bayer Advances BAY3018250 into Phase II Trial Following Successful Phase I Completion
Germany’s Bayer (ETR: BAYN) has launched a double-blind, placebo-controlled mid-stage trial for its potential first-in-class...
BMS Seeks FDA Priority Review for Krazati in Advanced Colorectal Cancer
Bristol Myers Squibb (BMS; NYSE: BMY) has submitted a priority review application to the U.S....
WuXi ATU’s Philadelphia Facility Approved for Amtagvi Production Following FDA Nod
WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec (SHA: 603259, HKG:...
HitGen’s Vernalis Partners with Hox Therapeutics to Develop Novel Cancer Inhibitors
HitGen Inc. (SHA: 688222), based in China, announced that its wholly owned subsidiary Vernalis (R&D)...
Merck’s Keytruda Under Priority Review for New Indication in Endometrial Carcinoma
This week, the U.S. FDA granted priority review status to an indication extension filing from...
Immune-Onc Therapeutics Partners with Roche for Phase Ib/II Study of IO-108 in Liver Cancer
Immune-Onc Therapeutics Inc., based in the U.S., is entering into a collaboration with Roche (SWX:...
Innovent Biologics Partners with ImmVirX to Launch Clinical Study Combining Tyvyt and IVX037
Innovent Biologics Inc. (HKG: 1801), based in China, has announced the signing of a clinical...
Biogen Appoints Ding Weibo as Head of Asia-Pacific Region, Succeeding Francis Wan
Biogen (NASDAQ: BIIB) has announced the appointment of Ding Weibo as the new head of...
Shenzhen Eureka Biotechnology Secures RMB 300 Million in Series B+ Funding for CGT Expansion
Shenzhen Eureka Biotechnology Co., Ltd., a specialist in cell and gene therapy (CGT) based in...
Mabwell Bioscience Receives FDA Green Light for B7-H3 Targeting ADC 7MW3711
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced...
BMS and Sichuan Biokin Commence Joint Development of EGFR/HER3-Targeted ADC
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese pharmaceutical company, has announced that a...
Everest Medicines Terminates Agreement with Providence Therapeutics, Retains mRNA Rights
Everest Medicines (HKG: 1952), a biopharmaceutical company based in China, has announced the termination of...
Jacobio Pharma Gets CDE Green Light for Phase III Study Combining Gleevec Inhibitors in NSCLC
Jacobio Pharma (HKG: 1167), a China-based pharmaceutical company, has announced that it has received approval...
Neurophth Biotechnology Completes Enrollment and Dosing in US Clinical Study for ND4-LHON Gene Therapy
Neurophth Biotechnology Ltd, a leading gene therapy specialist based in China, has announced the completion...
Biocytogen Pharmaceuticals Inks Antibody Evaluation Deal with Gilead Sciences
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (HKG: 2315), a China-based biopharmaceutical company, has announced an antibody...
Evopoint Biosciences Secures USD 97.2 Million in Series E Financing to Boost Clinical Trials and Commercialization
Evopoint Biosciences Co., Ltd., a Suzhou-based biopharmaceutical company, has announced the successful completion of a...
Phanes Therapeutics’ PT886 Receives CDE Approval for Clinical Trials in Advanced Solid Tumors
Sino-US biotechnology company Phanes Therapeutics Inc. has announced that it has received clinical trial approval...
ImmunoTech Biopharm Gets NMPA Green Light for Clinical Study of aT19 Injection for B-ALL
ImmunoTech Biopharm Ltd (HKG: 6978), a specialist in chimeric antigen receptor T-cell (CAR-T) therapies based...
Beijing, Tianjin, and Hebei Release Draft Proposal for Updated Drug Clinical Trial Inspection Standards
The medical products administration bureaus of Beijing, Tianjin, and Hebei province have released a draft...