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A new draft guidance from the FDA describes the benefit-risk principles the agency would apply when evaluating product quality for New Drug Applications (NDAs), Biologics License Applications (BLAs) or supplements to such applications. Read More
In a May 6 briefing before Congress, the director of the FDA’s Center of Biologics Evaluation and Research (CBER), Peter Marks, said the agency would not withhold authorization for a pediatric vaccine solely because it did not reach a 50 percent efficacy threshold at blocking symptomatic infection — a requirement that had been previously listed in FDA guidance. Read More
The FDA granted AstraZeneca a Priority Review for its blockbuster oncology drug, Imfinzi (durvalumab), combined with chemotherapy, for treatment of patients with locally advanced or metastatic biliary tract cancer (BTC), a rare cancer affecting the bile ducts and gallbladder. Read More
Novartis has paused production of two radioligand cancer therapies manufactured at its Ivrea, Italy, and Millburn, N.J., plants after potential quality issues surfaced. Read More
After resolving drug quality issues, Marinus Pharmaceuticals has resumed screening and recruitment for a phase 3 trial of its investigational drug ganaxolone in refractory status epilepticus (RSE). Read More
Almost 11 years after it granted Accelerated Approval, the FDA is withdrawing approval for Celgene’s (now Bristol Myers Squibb’s) peripheral T-cell lymphoma (PTCL) indication for Istodax (romidepsin) after the cancer drug didn’t achieve the primary endpoint in its confirmatory trial. Read More
AstraZeneca’s complement-5 inhibitor Ultomiris (ravulizumab-cwvz) has shown benefit in people living with a rare degenerative neuromuscular disorder called anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). Read More
The industry is speaking out about worries that must-pass legislation that reauthorizes FDA’s user fee programs might get bogged down with lawmakers’ projects and other effluvium that could alter the agreements FDA and industry have negotiated together. Read More