BioSpace News Archive

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 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.

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

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.

EpimAb Biotherapeutics and Almirall announced a license agreement on the development of bispecific antibodies for up to three undisclosed target pairs.

POXEL SA, a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis and rare metabolic disorders, announced that it will participate at two upcoming investor conferences.

Mestag Therapeutics announced the appointment of expert advisors Dr. Cassandra Choe-Juliak MD, formerly Chief Medical Officer at Flame Biosciences; Dr. Greg Elson, an expert in end-to-end development of novel antibody-based products with more than 30 years of industry experience; and Samantha Vieira MBA PMP, formerly Chief Operating Officer at Anjarium Biosciences.

Biovica International Biovica, active in cancer monitoring, announces the signing of an agreement providing access to DiviTum TKa to appropriate patients treated at a leading cancer center in Florida.