China’s CDE Issues Guiding Principles for ADC Research and Evaluation
China’s Center for Drug Evaluation (CDE) has issued a notification outlining the “Guiding Principles for...
GSK and Peers Respond to FTC Criticism, Withdraw Patent Listings from US Orange Book
Three pharmaceutical companies, including the UK’s GSK (NYSE: GSK), have responded to the Federal Trade...
Astellas Pharma Partners with Kelonia Therapeutics to Advance CAR-T Cell Therapies
Astellas Pharma Inc. (TYO: 4503) has announced a strategic research collaboration and licensing agreement with...
Denali Therapeutics Faces Setback as ALS Trial Fails to Meet Primary Endpoint
Denali Therapeutics (NASDAQ: DNLI) has announced disappointing results from a Phase II trial of its...
China’s NMPA Releases 77th Batch of Reference Drugs for Generic Quality Evaluation
The National Medical Products Administration (NMPA) has released the 77th batch of reference drugs for...
GSK’s Avodart Receives NMPA Approval to Resume Sales in China from September
The National Medical Products Administration (NMPA) has released a notification announcing that GlaxoSmithKline’s (GSK) Avodart...
National Health Commission Notification Signals New Poliovirus Containment Measures
The National Health Commission (NHC) has issued a notification announcing the establishment of the National...
China’s NHC Approves 2023 Large Medical Equipment Configuration Licenses, Targets Cancer Treatment
The National Health Commission (NHC) has granted approval for the Class A large medical equipment...
Hainan Poly Pharm Wins FDA Nod for Generic Version of UCB’s Vimpat
Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it...
US Lawmakers Call for Sanctions Against WuXi AppTec and WuXi Biologics Over National Security Concerns
US politicians have intensified their opposition to China’s biotech industry, with Congressmen and Senators sending...
Novartis Begins Review of 70% Stake in Indian Unit, Strategic Options Under Consideration
Novartis (NYSE: NVS) has initiated a review process concerning its 70.68% stake in Novartis India...
Boao Yiling Life Care Center Launches Innovative Dental Technologies Under Pilot Medical Policy
Boao Yiling Life Care Center has successfully completed the inaugural use of a dental comprehensive...
Brii Biosciences Acquires VBI Vaccines’ Intellectual Property and Manufacturing Rights in Strategic Deal
Brii Biosciences Ltd (HKG: 2137), based in China, has reached an agreement with US-based VBI...
LianBio to Wind Down Operations Amid Market Challenges, Announces Special Dividend
LianBio (OTCMKTS: LIANY), one of China’s prominent biotechnology firms, has announced plans to wind down...
NMPA Launches Pilot Program to Streamline Supplementary Drug Approval Process
The National Medical Products Administration (NMPA) has unveiled the “Pilot Work Plan for Optimizing the...
Organon Reports Q4 2023 Revenue Growth Driven by Women’s Health and Biosimilars
Organon (NYSE: OGN), the U.S.-based pharmaceutical company, has reported its fourth-quarter 2023 financial results, revealing...
Roche’s Xolair Gains FDA Approval to Combat IgE-Mediated Food Allergies in Patients Aged 1 and Up
Roche (SWX: ROG) has announced that the U.S. Food and Drug Administration (FDA) has granted...
Ipsen Secures FDA Approval for Onivyde Regimen as First-Line Treatment for Metastatic Pancreatic Adenocarcinoma
Ipsen (EPA: IPN, OTCMKTS: IPSEY), the France-based biopharmaceutical company, has announced that the U.S. Food...
FDA Approves Takeda’s Eohilia as First Oral Therapy for Eosinophilic Esophagitis in Patients Aged 11 and Up
The U.S. Food and Drug Administration (FDA) has granted approval to Takeda Pharmaceutical Company (TYO:...
Roche’s Piasky (Crovalimab) Secures NMPA Approval for Untreated Paroxysmal Nocturnal Hemoglobinuria
The National Medical Products Administration (NMPA) has granted marketing approval to Swiss pharmaceutical giant Roche...