Sanofi SA and Astrazeneca plc had a lot to celebrate July 17 when the FDA approved Beyfortus (nirsevimab) ahead of schedule, making it the first respiratory syncytial virus (RSV) prophylactic for infants in the U.S. “This is just really an historic day,” Michael Greenberg, a Sanofi vice president and medical head of the company’s North America vaccines unit, told BioWorld. The companies had been expecting the FDA decision later this quarter. The earlier approval suggests the FDA appreciated the urgency of having time for health systems and doctors to get the drug ahead of the next RSV season, Greenberg said. Read More
While the 12-month data from Bridgebio Pharma Inc.’s phase III ATTRibute-CM study testing acoramidis in transthyretin amyloid cardiomyopathy were deemed “puzzling” in late 2021, the 30-month results reported July 17 proved far more pleasing to investors. The trial hit all its endpoints and showed promising results on exploratory markers, sending company shares (NASDAQ:BBIO) up 76%, to close at $32.04, up $13.82. Read More
Dealmaking proved alive and well, with Sangamo Biosciences Inc. disclosing a tie-up worth as much as $1.19 billion with a subsidiary of Eli Lilly and Co., while Mirum Pharmaceuticals Inc. pledged to acquire for $445 million the bile-acid product portfolio owned by Travere Therapeutics Inc. Read More
Novartis AG just added muscle to its siRNA development effort by buying Dtx Pharma Inc. in an M&A deal that could total $1 billion. Novartis is getting a preclinical asset, DTx-1252, which just received the U.S. FDA’s orphan drug designation on June 8. Dtx is developing the siRNA candidate for treating the neuromuscular disease Charcot-Marie-Tooth disease type 1A (CMT1A). Basel, Switzerland-based Novartis will pay Dtx $500 million up front and make payments of up to $500 million in milestones completions. Read More
Newco Glycocore Pharma Srl is setting out to raise €10 million (US$11.2 million) in a series A round to take a novel approach to treating inflammatory respiratory diseases into the clinic, starting with a phase I/Ib trial in idiopathic pulmonary fibrosis. Read More
Camurus AB’s subcutaneous octreotide hydrochloride injection pen, CAM-2029, yielded statistically significant improvements in “multiple endpoints” in a 52-week phase III extension trial in patients with acromegaly, moving it closer to providing a more convenient treatment option for patients with the rare, chronic growth disorder than currently available therapies. Read More
GC Biopharma Corp., formerly Green Cross Corp., said July 17 that it refiled the BLA for its intravenous immune globulin agent Alyglo (GC-5107B; IVIG-SN 10%) to the U.S. FDA – nearly a year and a half after the regulator’s initial rejection. Read More
The biopharma industry experienced a notable decline in deal values and activity in June 2023, with a 48.51% decrease in deal values and a 43.62% decrease in the number of deals completed compared to the previous June. M&As, however, showed a remarkable 824.59% increase in value year over year in June, thanks to several billion-dollar transactions. Read More
Biopharmas raising money in public or private financings, including: 60 Degrees, Aatec, Brainstorm, Evogene, Janux, Neural, Petros, Turnstone. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Caeregen, Can-Fite, Eleven, Infinity, Ionis, Ligand, Medipacific, Mei, Novan, Novo Nordisk, Pardes, Pfizer, Seagen, Scipher. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Cel-Sci, Emmaus, Gilead, Scisparc. Read More
