News
In coordination with the United States President’s Emergency Plan for AIDS Relief, Gilead will make its twice-yearly HIV prophylactic Yeztugo available to resource-limited countries “at no profit.”
FEATURED STORIES
Analysts have had to throw out their assumptions for the biopharma industry’s recovery heading into the first quarter earnings period given the ongoing tariff drama.
Johnson & Johnson’s Joaquin Duato is no longer the highest paid CEO in pharma. Meanwhile, just two women make the top 10.
AI is enabling the development of a next generation of drugs that can more precisely target cancer cells while sparing healthy tissues.
Job Trends
Gilead Sciences, Inc. and Arcus Biosciences, Inc. announced an amendment to their collaboration agreement and a separate equity investment by Gilead of $320 million in Arcus common stock at $21.00 per share.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
THE LATEST
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.
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.
The company is pushing inhaled versions of common oral drugs with the hope of avoiding severe side effects.
What will Boston Pharmaceuticals CEO Sophie Kornowski do now that the company is selling off its pipeline and winding down operations? Whatever it is, data will take her there.
The biotech is planning to expand antisense oligonucleotide capabilities and infrastructure on campuses that already produce drugs such as the ALS therapy Qalsody.
Tidmarsh, an adjunct professor at Stanford’s medical school, brings decades of industry experience to the table. Serving as director of the Center for Drug Evaluation and Research will be his first government position.
The path to market for Roche’s astegolimab became more uncertain after the investigational antibody failed to significantly lower disease exacerbation rates versus placebo in patients with chronic obstructive pulmonary disease.
Otsuka and Lundbeck’s data are insufficient to establish significant efficacy of Rexulti plus sertraline in PTSD, according to the FDA’s outside experts.
In light of recent patient deaths, the FDA has also revoked its platform designation for Sarepta’s AAVrh74 technology. The designation, granted last month, was the first of its kind to be announced publicly.
Roche and Genentech were unable to sufficiently demonstrate the benefit of using Columvi in an earlier treatment setting for DLBCL in a U.S. population, according to the FDA.