Cancer
Pfizer-backed cancer company CellCentric will use the cash to support the launch of a pivotal myeloma trial testing its potentially first-in-class oral treatment this year.
The action affects BioNTech sites in Germany and Singapore, where the company expects to have excess capacity.
The advisory committee meeting—the FDA’s first drug-related adcomm in nine months—could have been a “more conceptual discussion” about the design of AstraZeneca’s Phase 3 trial of camizestrant in HER2-negative advanced breast cancer, former cancer regulator Harpreet Singh told BioSpace.
Summit Therapeutics planned an early interim progression-free survival readout for HARMONi-3 in the hope of enabling earlier regulatory engagement—but the early analysis delivered disappointment for the company and shareholders.
Veppanu, the first PROTAC therapy approved by the FDA, improved progression free survival by 43% versus AstraZeneca’s Faslodex but showed no such significant benefit in the intention-to-treat analysis.
The FDA is looking at a slew of label expansions this month, including one that could open up home-based treatments for Alzheimer’s disease.
Members of the FDA’s Oncologic Drugs Advisory Committee questioned the design of AstraZeneca’s Phase 3 trial of camizestrant, which involved switching treatments at the point of mutation detection, as opposed to the current practice of changing regimens upon disease progression.
While AstraZeneca has discontinued work on four assets—including one in asthma and another in acromegaly—the pharma has also elected to take forward a bispecific antibody that destroys the EGFR protein.
We must treat drug resistance as a central scientific priority rather than an unavoidable complication.
Strong growth in immunology and neurology prompted AbbVie to raise its 2026 outlook and consider future M&A from a position of “ample financial capacity.”
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