BMO Capital Markets pointed to FDA leadership, and CBER Director Vinay Prasad in particular, as potential factors in the agency’s decision to issue a complete response letter for Replimmune’s viral treatment RP1 for advanced melanomas. Shares of the company tumbled 75% on Tuesday.
Replimmune Plummets Following FDA’s Surprise Rejection of Melanoma Treatment Read More »
Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, the Duchenne patient community fears losing access to Elevidys while the regulator considers more drastic action.
Lack of Transparency Tarnishes Sarepta’s Sheen as Patient Deaths Trigger FDA Battle Read More »
The announcement follows reports that the dental equipment company was considering a sale after receiving takeover offers.
ZimVie to sell to investment firm for about $730M Read More »
A new National Bureau of Economic Research analysis links hospital-physician consolidation to lower competition and higher costs down the line. The American Hospital Association slammed the study as flawed.
Hospitals are buying more doctor’s offices. That’s tied to higher costs, study finds Read More »
The acquisition, which will give Sanofi a combination vaccine for respiratory syncytial virus and human metapneumovirus, follows the pharma’s potential $1.4 billion COVID vaccine licensing deal with Novavax last year, plus a number of other big-ticket commitments outside of the vaccine space.
Sanofi Makes $1.6B Vaccine Bet With Vicebio Acquisition Read More »
The company is pushing inhaled versions of common oral drugs with the hope of avoiding severe side effects.
Avalyn Pharma Adds $100M Series D for Inhaled Pulmonary Fibrosis Drugs Read More »
After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, noting the need to maintain a good working relationship with the regulator.
Sarepta Concedes to FDA Request, Suspends US Shipments of Elevidys Read More »
In this episode presented by Eclipsebio, BioSpace’s head of insights Lori Ellis continues the discussion on mRNA and srRNA with Andy Geall of Replicate Bioscience and Alliance for mRNA Medicines, and Pad Chivukula of Arcturus Therapeutics.
In May, biotech iTeos Therapeutics decided to close down after being abandoned by GSK over the disappointing mid-stage performance of its anti-TIGIT antibody belrestotug.
Concentra Buys Beleaguered iTeos at Slight Discount Read More »
The money will focus on a manufacturing plant in Virginia that will make the company’s weight management and metabolic drugs like the hypertension drug baxdrostat and oral GLP-1 therapies.
With Potential Tariffs Weeks Away, AstraZeneca Makes $50B U.S. Manufacturing Push Read More »
