Belief BioMed and Takeda’s Hemophilia B Gene Therapy BBM-H901 Accepted for NMPA Review
Belief BioMed Group (BBM), a Shanghai-based gene therapy specialist, and Takeda have announced that the...
Rare / orphan disease drugs
IASO Biotherapeutics’ CAR-T Therapy Fucaso Receives FDA IND Approval for Multiple Sclerosis
China-based IASO Biotherapeutics has announced that it has received Investigational New Drug (IND) approval from...
China’s NMPA Considers Breakthrough Designations for Xiangxue and Innostellar’s Therapies
Xiangxue Pharmaceutical Co., Ltd (SHE: 300147) and Innostellar Biotherapeutics Co., Ltd have both been noted...
AccurEdit Therapeutics Receives CDE Approval for Gene Editing Drug ART001 Targeting Amyloidosis
AccurEdit Therapeutics (Suzhou) Co., Ltd, a leading specialist in gene editing therapies based in China,...
Bain Capital-Backed Tenacia Wins NMPA Approval for Ganaxolone Oral Suspension for CDKL5 Deficiency
Tenacia, a central nervous system (CNS) specialist company incubated by Bain Capital, has announced that...
Mabwell Bioscience Lands Orphan Drug Status for B7-H3 Targeting ADC in Small Cell Lung Cancer
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has been granted Orphan Drug Designation (ODD) by...
Johnson & Johnson’s Opsumit Faces Generic Competition with Qilu Pharmaceutical’s Entry
Johnson & Johnson (J&J, NYSE: JNJ)’s pulmonary hypertension treatment, Opsumit (macitentan), is set to encounter...
Staidson Pharmaceutical Gets NMPA Green Light for Neurotrophic Keratitis Eye Drop Clinical Trial
Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a biopharmaceutical company based in China, has announced...
Novo Nordisk’s Esperoct Receives NMPA Approval, First Long-Acting Factor VIII for Hemophilia A in China
The National Medical Products Administration (NMPA) has granted approval to Novo Nordisk (NYSE: NVO), a...
CStone Pharmaceuticals Partners with Hengrui for Promotion of Ayvakit in China
CStone Pharmaceuticals (HKG: 2616), a biopharmaceutical company based in China, has announced a licensing agreement...
Staidson Pharmaceutical’s Bemiltenase Alfa Earns Orphan Drug Designation from US FDA for Hemophilia Treatment
Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a biopharmaceutical company based in China, has announced...
Johnson & Johnson Achieves Positive Phase III Results for Nipocalimab in Generalized Myasthenia Gravis
Johnson & Johnson (J&J, NYSE: JNJ), a leading US-based healthcare company, has announced positive results...
Harbour BioMed Resubmits Biological License Application for Batoclimab in China
Harbour BioMed (HKG: 2142), a biopharmaceutical company with operations in the United States, the Netherlands,...
Qilu Pharmaceutical’s Generic Version of Vyndaqel Receives NMPA Marketing Approval
The National Medical Products Administration (NMPA) has granted marketing approval to Qilu Pharmaceutical’s generic version...
Takeda’s Soticlestat Misses Primary Endpoints in Phase III Epilepsy Trials
Takeda Pharmaceutical Co., Ltd (TYO: 4502; NYSE: TAK), a leading Japanese pharmaceutical company, has announced...
AbbVie-Calico Partnership Advances with FDA Approval for Fosigotifator Trial in Rare Brain Disorder
The US Food and Drug Administration (FDA) has welcomed an experimental therapy, fosigotifator, developed by...
Wanbangde’s Huperzine A Earns Orphan Drug Status from FDA for Treating Neonatal Brain Injury
Wanbangde New Building Materials Co., Ltd (SHE: 002082), a company operating in China, has announced...
Amgen’s Bkemv Becomes First Biosimilar to Challenge AstraZeneca’s Soliris with FDA Approval
Amgen Inc. (NASDAQ: AMGN), a leading biopharmaceutical company, has been granted regulatory approval by the...
RareStone Group’s Pitolisant Secures NMPA Approval to Treat Narcolepsy in Children and Adolescents
RareStone Group, a China-based company specializing in rare diseases (formerly known as Citrine Medicine), has...
Novartis’ Fabhalta Shows Promise in Late-Stage C3 Glomerulopathy Trial
Novartis AG (NYSE: NVS), a leading Swiss pharmaceutical company, last week announced positive preliminary data...