BioSpace News Archive

Drug Development

Tempest’s Stock Skyrockets 4,000% on Early Data for Hepatocellular Carcinoma

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.

October 12, 2023
·
2 min read
·
Tristan Manalac
Drug Development

Opinion: Akero’s Three-Step Plan to Win Back Investors

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

October 12, 2023
·
3 min read
·
Jia Jie Chen
Drug Development

FDA Action Alert: Merck, Ardelyx, BioMarin and More

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

October 12, 2023
·
6 min read
·
Tristan Manalac
Business

Biogen Lays Off 113 Reata Employees Weeks After Completing $7B Acquisition

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.

October 12, 2023
·
2 min read
·
Tristan Manalac
Policy

FDA Rejects Alvotech’s Stelara Biosimilar as Manufacturing Problems Continue

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.

October 12, 2023
·
2 min read
·
Tristan Manalac
Drug Development

Lilly’s Mirikizumab Shows Long-Term Remission in Phase III Crohn’s Trial

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.

October 12, 2023
·
1 min read
·
Kate Goodwin
EpimAb Biotherapeutics and Almirall Announce Bispecific Antibody License Agreement

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

October 12, 2023
·
3 min read
Biotech Bay

New Data for Genentech’s Ocrevus Show That After 10 Years of Treatment 77% of People With Relapsing Multiple Sclerosis Were Free From Disability Progression and 92% Continue to Walk Unaided

Genentech, a member of the Roche Group, announced new clinical and real-world data for Ocrevus® demonstrating its role in continuing to transform care for people living with relapsing or primary progressive multiple sclerosis presented at the 9th Joint ECTRIMS-ACTRIMS Meeting.

October 12, 2023
·
15 min read
BIOCAPTIVA to conduct ex-vivo study to evaluate the potential of the BioCaptis device to capture cell free DNA to improve pleural disease diagnosis

BIOCAPTIVA Ltd announces initiation of an ex-vivo study to establish if, using its BioCaptis device, pleural fluid cfDNA can be isolated from exudative pleural fluid samples in sufficient quantities for downstream DNA analysis to improve pleural disease diagnosis.

October 12, 2023
·
4 min read
Drug Development

AlzeCure Presents Clinical Phase II-Data with ACD440 for Neuropathic Ppain at Pain Conference

AlzeCure Pharma AB announced that the company’s presentation at the pain conference held by the Swedish Pain Society is now available in its entirety on the company’s website.

October 12, 2023
·
5 min read