News from Biogen Inc. and partner Eisai Co. Ltd. that U.S. regulators accepted the BLA related to aducanumab for Alzheimer’s disease (AD) – and assigned it priority review, no less – set Wall Street abuzz, especially as the companies noted in their press release that the FDA “if possible, plans to act early” on the anti-amyloid beta (a-beta) monoclonal antibody. Regulators’ decision came about 30 days after they took receipt of the submission; they could have waited 60. Read More
More than two weeks ahead of its expected PDUFA date, PTC Therapeutics Inc.’s spinal muscular atrophy (SM) drug, risdiplam, gained FDA approval, making it the first at-home, oral treatment intended for use in adults and children 2 months and older. Read More
Bayer AG’s Lampit (nifurtimox) to treat Chagas disease in pediatric patients, approved by the FDA on Friday, is an oral, antiprotozoal medication for newborns to patients under 18, who weigh at least 2.5 kg and are diagnosed with Chagas disease caused by Trypanosoma cruzi. Read More
HONG KONG – Osaka, Japan-based Ono Pharmaceutical Co. Ltd. has obtained positive top-line data in its phase III study of a combination of Opdivo (nivolumab, Bristol Myers Squibb Co.) and bevacizumab in lung cancer patients. Read More
KARACHI, Pakistan – Geopolitics and a fraught relationship with its neighbors are hurting Pakistan’s pharmaceutical industry and the ability of people to access active pharmaceutical ingredients (APIs) and modern drugs. Read More
BioWorld looks at translational medicine, including: PRC member affects blood formation during aging; Localized bile acid improves systemic blood glucose control; After injury, astrocytes can make interneurons; In AML, collapse prevents relapse; Starving out Chlamydia. Read More
As the money keeps rolling in, 2020 is certainly a year for the biopharma record books. With a total of $81.26 billion raised through Aug. 6, it is a standout year in every type of financing, hitting all kinds of record highs. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Altimmune, Cstone, Everest, Ligand, Oncolys, Oncopeptides, Roche, Satsuma. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Allergan, Cancer Targeted Technology, Conifer, Editas, Ensysce, Ev, Eversana, Gilead, Immvira, Lodo, Moderna, Mucokinetica, Novavax, Nura, Pfizer, Shanghai Pharmaceuticals, Takeda, Yulong, Zosano. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Biogen, Canbridge, Cytodyn, Eisai, Intellia, Kazia, PTC, Roche, Viiv. Read More
