Opioid-related hazards with Alkermes plc’s combo drug ALKS-3831 – specifically, with the samidorphan element – and the significance of weight-gain reduction brought about by the tablet, which also includes olanzapine, became key topics in the joint meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. Read More
A phase III failure of Swedish Orphan Biovitrum AB's oral thrombopoietin receptor agonist avatrombopag to effectively outperform a placebo in treating chemotherapy-induced thrombocytopenia, or low platelet counts, sent company shares down 17.9% on Oct. 9. Read More
As clinical trials, halted due to the COVID-19 pandemic, begin to resume and biopharma companies find workarounds to keep the research going, activity in phase I, II and III studies picked up by more than 40% in September. Read More
The regulatory path for Saniona AB’s Tesomet for treating two rare eating disorders, Prader-Willi syndrome (PWS) and hypothalamic obesity, continues to be a winding one with surprises along the way. The newest twist is pre-IND feedback from the FDA that knocked the stock down 10.5% on Oct. 9. Read More
BEIJING – Three-year-old startup Everest Medicines Ltd. (1952.HK) sold 63 million shares at HK$55 apiece to raise HK$3.49 billion (US$451 million) on the Hong Kong Stock Exchange on Oct 9. Shares were oversubscribed by 654 times in Hong Kong. Read More
Investigators at the University of Heidelberg have identified a previously unknown mechanism for excitotoxicity and used their insight to identify “unconventional neuroprotectant” compounds that could prevent cell death and reduce brain damage in a mouse model of stroke. Read More
HONG KONG – Galmed Pharmaceuticals Ltd. has struck an agreement with Ascletis Pharma Inc.’s Gannex arm to develop a combination therapy comprising Ascletis’ ASC-41 and Galmed’s Aramchol (arachidyl amido cholanoic acid) for nonalcoholic steatohepatitis (NASH). Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apellis, Bold, Caladrius, CSL, Emergent, Gilead, Grifols, Pfizer, Rigel, Sobi, Sumitomo Dainippon, Takeda, University of Oxford. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allarity, Inspyr, Kymera, Lilly, Oncology Venture, Precigen, Selecta, Merck KGaA, Ridgeway, Vir. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Axovant, Foresee, Innovent, Italfarmaco, Saniona. Read More
