Industry News
Biotechnology Industry News
The FDA has accepted Stealth…
The FDA has accepted Stealth BioTherapeutics’ third new drug application for its ultrarare disease candidate, providing a planned decision date of Sept. 26.
Gilead has become the latest…
Gilead has become the latest pharma to strengthen its in vivo cell therapy credentials this year, paying $350 million for CAR-T developer Interius BioTherapeutics.
Dynavax’s lofty ambition to…
Dynavax’s lofty ambition to snatch Shingrix’s crown got off to a promising start after the biopharma’s investigational shingles vaccine held its own against GSK’s mainstay in the first part of a phase 1/2 study.
The FDA has freed Rocket…
The FDA has freed Rocket Pharmaceuticals from a clinical hold, giving the gene therapy developer permission to take flight with its pivotal cardiomyopathy disease trial.
Xoma Royalty is ravenous for…
Xoma Royalty is ravenous for biotechs, and the Bay Area licensing aggregator has found its next meal in Mural Oncology. Xoma is set to acquire Mural for $2.035 per share, for a total value of
The first half of 2025 was brutal…
The first half of 2025 was brutal for biotech, but investors are still keen on therapeutics in several indications and silver linings exist, particularly for private companies.
Jazz Pharmaceuticals has struck a…
Jazz Pharmaceuticals has struck a deal to bolster its epilepsy ambitions, paying Saniona $42.5 million upfront for a preclinical asset designed to address problems faced by GSK’s withdrawn drug Potiga.
Celldex has stopped development of…
Celldex has stopped development of barzolvolimab in eosinophilic esophagitis (EoE) despite meeting its primary endpoint in a phase 2 study. The biotech showed the candidate depletes mast cells in the gastrointestinal tract, but that positive
Despite missing its primary…
Despite missing its primary endpoint in a phase 3 study, PTC had held out hope that another endpoint would help its candidate pass muster with the FDA.
Viking Therapeutics has reported…
Viking Therapeutics has reported phase 2 data on its oral obesity drug candidate, linking the peptide to weight loss of up to 12.2% after 13 weeks. But with 38% of patients discontinuing treatment at the
Delays from the Food and Drug…
Delays from the Food and Drug Administration continue to pile up, with Maryland-based Regenxbio the latest to report the review of one of its assets has been extended.
Halda Therapeutics has struck a…
Halda Therapeutics has struck a deal with VantAI, entering into a pact that could be worth more than $1 billion to secure a source of targets for its novel approach to oncology and immunology.
China’s RemeGen has sold certain…
China’s RemeGen has sold certain Asia rights to its phase 3-stage eye disease drug to Japan’s Santen Pharmaceutical for 250 million Chinese yuan ($34.8 million) upfront.
Opthea’s options may be…
Opthea’s options may be shrinking as the eye disease biotech comes to terms with a pair of phase 3 failures, but the company isn’t quite ready to give up.
CSL is laying off up to 15% of its…
CSL is laying off up to 15% of its workforce as the company looks to cut R&D costs and spin out its vaccine subsidiary.
Gene therapy biotech Kriya…
Gene therapy biotech Kriya Therapeutics has secured $313 million in a new series fundraise.
Genentech’s summer of downsizing…
Genentech’s summer of downsizing and cost-cutting continued this morning, with the Roche subsidiary announcing the termination of a cell therapy deal worth as much as $2 billion. The pact with Adaptive Biotechnologies, originally launched in
In the pharmaceutical quality…
In the pharmaceutical quality environment, change is often reactive, driven by unfavorable events like deviations, equipment failure, or health authority observations.
After an FDA rejection in May,…
After an FDA rejection in May, Stealth BioTherapeutics has resubmitted a new drug application for its investigational treatment designed to treat an ultra-rare genetic disease.
Yet another biotech is facing a…
Yet another biotech is facing a delay from the Food and Drug Administration as the agency reels from intense staffing cuts. Neurizon, an Australian biotech focusing on neurodegenerative diseases, will now have to wait until