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Clene’s gold nanocrystal asset CNM-Au8 failed to hit the primary endpoint in the HEALEY ALS trial, but strong survival signals at six months warrant additional exploration in treating ALS.
Intercept Pharmaceuticals’ Ocaliva failed to treat patients with compensated cirrhosis due to nonalcoholic steatohepatitis better than a placebo in a Phase III trial, the company announced Friday.
The third quarter of 2022 saw continued job cuts, a shift in focus away from COVID-19, an unexpected boost in the Alzheimer’s research space and increased scrutiny of accelerated approvals.
Gene therapies developed by Janssen, Atsena, REGENXBIO and AbbVie showed promise against eye diseases this weekend at the American Academy of Ophthalmology 2022 meeting.
Myovant Sciences formed a special committee of independent directors to assess Sumitovant Biopharma’s offer after Sumitovant announced plans to acquire the company.
AstraZeneca is acquiring LogicBio Therapeutics in a deal worth $68 million. The deal bolsters AstraZeneca’s efforts to braoden its portfolio in genomics and rare diseases.
The FDA’s approval of Amylyx’s Relyvrio has ignited the growing momentum in the ALS space. BioSpace spoke with Amylyx co-CEOs Justin Klee and Josh Cohen and leading ALS researcher Dr. Merit Cudkowicz.
Theratechnologies’ Trogarzo for HIV, Alnylam’s Lumasiran for advanced primary hyperoxaluria, scPharmaceuticals’ Furoscix for heart failure and more. Here’s a look at the FDA’s October calendar.
Biopharma companies are expanding beyond the traditional confines of Massachusetts and California with hubs forming – most notably – in the South and Southeast.
The FDA had a busy week, approving drugs, greenlighting clinical trials and other regulatory activities for Immuneering, Amylyx, Sarepta, Sanofi, and Regeneron and more.
Shares of Rocket Pharmaceuticals jumped Friday morning after the company announced positive clinical updates from a Phase I study of patients diagnosed with Danon disease.
In its ongoing battle against counterfeit drug rings, Gilead Sciences announced it has identified two “kingpins” behind the scheme to sell illegitimate HIV medications.
