BioSpace News Archive

In a Phase Ib/II study, Tempest Therapeutics’ investigational PPAR⍺ antagonist—combined with Roche’s Avastin and Tecentriq—showed strong signs of survival benefits in liver cancer patients.

Shares of Akero Therapeutics took a hit after the company missed the primary endpoint in a Phase IIb study of efruxifermin in nonalcoholic steatohepatitis.

The layoffs, set to take effect in late November, will impact about a third of Reata’s headcount. The workforce reduction comes just weeks after Biogen completed its $7.3 billion Reata buy.

The regulator issued a Complete Response Letter citing “deficiencies” at the company’s Reykjavik plant, this time for its Stelara biosimilar AVT04. It’s the fourth FDA rejection for Alvotech since last year.

More than 54% of patients treated with mirikizumab achieved clinical remission at 52 weeks versus 19.6% of those on placebo. Eli Lilly will submit a marketing application in Crohn’s disease to the FDA in 2024.

The FDA is gearing up for six decisions in the next two weeks, two of which involve highly anticipated medicines for rare diseases.

Avenge Bio, Inc. today announced participation in the upcoming investor conference.

Insmed Incorporated today announced that it will release its third-quarter 2023 financial results on Thursday, October 26, 2023.

Seagen Inc. (Nasdaq: SGEN) announced today that it will report third quarter 2023 financial results on Wednesday, November 1, 2023.

Former BMS, Pfizer leader to help AI-driven company accelerate its development of novel medicines discovered via its proprietary RNA foundation model Atomic AI, a biotechnology company fusing cutting-edge machine learning with state-of-the-art structural biology to unlock RNA drug discovery, announced the addition of Manjunath “Manju” Ramarao, Ph.D., as Chief Scientific Officer.