Bluebird Bio Inc., of Cambridge, Mass., said it has begun an underwritten public offering of $400 million of its common stock and intends to grant the underwriters a 30-day option to purchase up to an additional 15 percent of the shares offered in the public offering. Read More
The FDA Tuesday launched a public campaign focused on recruiting employees with the skills to help the agency to meet the challenges of rapid advances in science, medicine and technology. The campaign, which includes social media and print ads in the Washington Metropolitan Area Transit Authority system, is designed to appeal to people who "want to make a difference." The campaign is part of broader efforts to help the FDA attract the best and brightest candidates using new human resources' authorities provided through the 21st Century Cures Act. Read More
C4X Discovery Holdings plc, of Manchester, U.K., said that its C4X-3256 program has been awarded a grant from the National Institute on Drug Abuse of about $480,000 that will support preclinical development of the candidate in cocaine use disorder. The oral orexin-1 receptor antagonist was recently licensed to Indivior UK Ltd. Read More
Eight years after opening its doors, 60 Degrees Pharmaceuticals LLC is preparing for its FDA advisory committee debut Thursday with an antimalarial drug developed through a licensing and research agreement with the U.S. Army Medical Materiel Development Activity. Read More
HONG KONG – A University of Hong Kong (HKU) study has shown that a new small-molecule non-antibiotic compound has potent efficacy against methicillin-resistant Staphylococcus aureus (MRSA), making it a promising lead compound for developing anti-virulence drugs against S. aureus. Read More
Hoping to repeat its phase II success, Aldeyra Therapeutics Inc. enrolled the first patient in its pivotal phase III trial testing a topical version of its aldehyde trap, reproxalap, in ichthyosis associated with Sjögren-Larsson syndrome (SLS), a rare disease for which there are no approved therapies. Read More
Sutro Biopharma Inc.'s deal with Merck & Co. Inc. puts $60 million in the bank immediately and could garner as much as $1.6 billion more in milestone payments as the companies put Sutro's cell-free protein synthesis and site-specific conjugation platforms to work in a bid for immune-modulating cytokine derivatives targeting oncology and autoimmune indications. Read More
A strong second quarter at Biogen Inc., buoyed by increasing demand for the spinal muscular atrophy drug Spinraza (nusinersen) and a better-than-expected quarterly profit, helped the company beat consensus earnings estimates and raise its 2018 financial guidance. Appreciation for completed enrollment in the company's two phase III studies of the Alzheimer's disease (AD) candidate aducanumab and interest in a newly announced acquisition of a muscle enhancement program from Alivegen Inc. also helped. Read More
Orilissa (elagolix) became the latest potential blockbuster to pass FDA scrutiny and the first drug in more than a decade approved to treat moderate to severe pain associated with endometriosis. Read More
