Morphosys AG is to acquire Constellation Pharmaceuticals Inc., financed by gambling a huge chunk of its income on the U.S. firm’s BET inhibitor pipeline drug – an approach that has to date produced mixed results in cancer. Read More
Following a priority review, Scynexis Inc.'s oral antifungal, Brexafemme (ibrexafungerp), has won FDA approval for the treatment of vaginal yeast infections, also known as vulvovaginal candidiasis. The one-day oral treatment, which kills a broad range of Candida species, including azole-resistant strains, represents the first approved drug in a new antifungal class in more than 20 years as well as being Scynexis’ first commercial product. Read More
Protalix Biotherapeutics Inc. saw shares dip after releasing initial top-line data from an interim analysis of the phase III Balance clinical trial of pegunigalsidase alfa (PRX-102) to treat Fabry disease. The 24-month, randomized, double-blind, active control study is evaluating the safety and efficacy of 1 mg/kg of PRX-102 dosed every two weeks compared to agalsidase beta (Fabrazyme). Two of the study’s 78 patients dropped out because of treatment emergent adverse events and one left because of a related adverse event. Read More
Public biopharmaceutical companies did manage to attract some investors off the sidelines in May with medical conference season getting into full gear. However, it was generally another lackluster month, with the Nasdaq Biotech index dropping 2% in the period in contrast to the broader markets with the Dow Jones Industrial Average growing by 2%. The sector, however, could get a significant boost in the next few days if the FDA gives the green light to Biogen Inc. and Eisai Co. Ltd.’s experimental Alzheimer’s disease therapy, aducanumab, a recombinant chimeric human IgG1 monoclonal antibody targeting beta-amyloid, that could be the first disease-modifying therapy for an indication that has seen no novel therapies approved in more than 15 years. Read More
Kyowa Kirin Co. Ltd. has partnered with Amgen Inc. to jointly develop and commercialize KHK-4083, Kyowa Kirin’s phase III-ready anti-OX40 fully human monoclonal antibody for the potential treatment of atopic dermatitis. Kyowa Kirin will receive a $400 million up front, while milestone payments could add an additional $850 million. Significant royalty payments on future global sales could sweeten the blockbuster deal. Read More
LONDON – In a sizeable seed round for a U.K. biotech, Transine Therapeutics Ltd. has raised £9.1 million (US$12.9 million) to take forward a novel method for up-regulating endogenous protein production using a naturally occurring class of long noncoding RNAs. Read More
LONDON – Adding to the immediate and obvious toll of serious illness and death, COVID-19 seems likely to be fueling development of resistance to antibiotic drugs, according to the findings of the most comprehensive analysis to date. Read More
Borrowing a chapter from venture capitalists, the U.S.’ Biomedical Advanced Research and Development Authority (BARDA) is partnering with the nonprofit Global Health Investment Corp. (GHIC) to accelerate the development and commercialization of medical technologies and products needed to respond to or prevent future pandemics and other public health emergencies. Read More
A lawsuit filed last year challenging a federal rule and certification allowing certain drugs to be imported from Canada should be dismissed because no drug companies have been harmed yet, nor are they likely to be any time soon, the Biden administration said in a motion seeking dismissal of the suit. Read More
Novartis AG is closing in on a label expansion for its blockbuster inflammatory disease drug, Cosentyx (secukinumab), after announcing supportive phase III results in children with two subtypes of juvenile idiopathic arthritis (JIA). Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amryt, BMS, Boehringer, Inmune, Janssen, Kamada, Karyopharm, Kedrion, Novartis, RDIF, Roche, Scynexis, Sinovac, Soleno, Stealth, Tetra, Zealand. Read More
