The whopper deal between Biogen Inc. and Sage Therapeutics Inc. – a global collaboration and licensing deal involving the latter’s zuranolone (also known as SAGE-217) for major depressive disorder (MDD), postpartum depression (PPD) and other psychiatric disorders, as well as SAGE-324 for essential tremor (ET) and neurological disorders – drew mixed reviews from Wall Street. And, for Biogen investors, the would-be Alzheimer’s disease (AD) therapy aducanumab remains front of mind. Read More
Rhythm Pharmaceuticals Inc., a company developing medicines for rare genetic disorders of obesity, has won FDA approval for its first product, Imcivree (setmelanotide), following a priority review. The drug is designed to restore a biological pathway that, when disrupted, can lead to constant hunger. The approval covers the treatment of three types of ultrarare early onset obesity tied to pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) and leptin receptor (LEPR) deficiencies, when confirmed by genetic testing. Read More
LONDON – The Google artificial intelligence company Deepmind has developed an algorithm that can predict the 3D structure of a protein from its amino acid sequence, making it possible to solve the structures of proteins, such as G-protein coupled receptors (GPCRs), which are a mainstay of drug targeting but whose structure is challenging to determine with current methods. Read More
Just ahead of the U.S. celebration of Thanksgiving, the FDA granted an accelerated approval for Danyelza (naxitamab), a new therapy for certain adults and children with relapsed or refractory high-risk neuroblastoma. The antibody, which Y-mabs Therapeutics Inc. initially sublicensed via a deal with Mabvax Therapeutics Inc. in 2018, is approved for use in combination with granulocyte macrophage colony-stimulating factor. The regulator had assigned the BLA a Nov. 30 PDUFA date.<
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Moderna Inc., late on Nov. 30, said it has asked the FDA to bless emergency use of its COVID-19 vaccine mRNA-1273 after phase III data confirmed it to be 94.1% effective in preventing symptomatic cases of the disease and 100% effective in preventing severe cases. The Cambridge, Mass.-based company said efficacy was "consistent across age, race and ethnicity and gender demographics." Read More
If there are three takeaways from this year’s dealmaking efforts, they appear to be record-setting partnerships, lackluster M&As, and massive amounts of research funding via the U.S. government. Read More
New York-based Hookipa Pharma Inc.’s positive interim data from a phase II study with what could become the first approved cytomegalovirus (CMV) vaccine, HB-101, lifted shares (NASDAQ:HOOK) to a high of $13.25 early in the day but the price leveled off later to close Nov. 30 at $11.60. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Pandemic not the time for trade restrictions; Longer-term vaccine follow-up crucial; Labeling update advised for chloroquines; FDA stands up new DDT path; FDA drafts DDI guidance; MHRA continues Brexit updates; FDA debars three. Read More
Biopharmas raising money in public or private financings, including: Acerus, Achieve, Adrenomed, Advaxis, Eluminex, Kinaset, Sigilon, Silverback, Spotlight. Read More
