CNIPA Upholds Alynlam Pharmaceutical’s PCSK9 siRNA Patent Against Junshi Biosciences Challenge
The China National Intellectual Property Administration (CNIPA) has rejected a challenge filed by Junshi Biosciences...
Drug
Sanofi’s Dupixent Secures NMPA Approval for Pruritigo Nodosa Treatment in China
France-based pharmaceutical company Sanofi (NASDAQ: SNY) has announced that it has received another indication approval...
Suzhou Zelgen Biopharmaceuticals’ ZG005 Receives NMPA Approval for Solid Tumor Trial
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a China-based pharmaceutical company, has announced that it...
Antengene’s Anti-CD24 Antibody ATG-031 Gets Green Light for Phase I Study at MD Anderson
Antengene Corporation Ltd (HKG: 6996), a China-based biopharmaceutical company, has announced that the Institutional Review...
Mabwell Bioscience’s 9MW3011 Earns US FDA Fast Track Designation for Polycythemia Vera Treatment
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced that it...
Novartis’s Aimovig Approved by China’s NMPA for Preventive Migraines Treatment
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that it has received market approval from...
Organon’s Liptruzet Approved in China for Hypercholesterolemia Treatment
US-based Organon (NYSE: OGN) has announced that it has received market approval from the National...
Hainan Poly Pharm Submits DMF for Tecovirimat API to US FDA
China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced the filing of a Drug...
Tonghua Golden-Horse’s Octohydroaminoacridine Succinate Meets Phase III Endpoints in Alzheimer’s Disease
China-based Tonghua Golden-Horse Pharmaceutical Industry Co., Ltd. (SHE: 000766) has announced positive results from its...
AIM Vaccine’s Serum-Free Rabies Vaccine Completes Phase III Safety Observation
China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced the successful completion of the 7-day...
Jiangsu Yahong’s Cevira Meets Primary Endpoint in Phase III Cervical HSIL Study
Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer treatments, has...
Hybio Pharmaceutical Gets NMPA Approval for COVID-19 Nasal Spray HY3000
China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has received approval from the National Medical Products...
GSK’s Ojjaara Approved by FDA for Anemic Myelofibrosis Patients
The US Food and Drug Administration (FDA) has granted regulatory approval to GlaxoSmithKline (GSK; NYSE:...
BeiGene Regains Full Rights to Tislelizumab After Terminating Novartis Deal
China-based biotech company BeiGene (NASDAQ: BGNE) has reached a mutual agreement with Novartis (NYSE: NVS)...
Jiangsu Hengrui Pharmaceuticals Wins NMPA Approval for Two Novel Drug Candidates
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced receiving...
Pfizer’s Cibinqo and Everest Medicines’ Cefepime-Taniborbactam Selected for Priority Reviews by CDE
The Center for Drug Evaluation (CDE) has indicated on its website that Pfizer’s (NYSE: PFE)...
EMA’s CHMP Supports Gilead’s Veklury for COVID-19 Patients with Hepatic Impairment
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recently...
FDA Grants Priority Review to MSD’s Welireg for Advanced RCC Indication Extension
The US Food and Drug Administration (FDA) has granted priority review status to an indication...
Astellas Pharma’s Xtandi NDA for mHSPC Treatment Accepted by China’s CDE
Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the Center for Drug Evaluation (CDE)...
Pfizer’s Litfulo Earns EU Approval as First Treatment for Severe Alopecia Areata in Teens
Pfizer (NYSE: PFE) has been granted registration authorization by the European Commission (EC) for Litfulo...