FDA
The DC-based biopharma disputed the FDA’s conclusions regarding the data provided in its supplemental application for Hetlioz and promised to keep pushing for an approval.
FEATURED STORIES
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
There was a lot of news and research studies today related to the COVID-19 vaccines. Here’s a look.
Merck announced positive results from the late-stage KEYNOTE-522 study that should support its previous attempt that was stymied by a regulatory advisory committee in February and rejected by the U.S. FDA in March.
Clearance of the IND allows Samus to proceed with a Phase Ib trial to assess the safety, tolerability and pharmacokinetics of PU-AD in a small group of patients with recurrent malignant glioma.
The U.S. FDA expanded the Emergency Use Authorization for the Pfizer and BioNTech vaccine to include adolescents ages 12 to 15 after clinical data showed 100% efficacy response.
May is a busy month for the U.S. Food and Drug Administration (FDA)’s calendar for new drug reviews. Here’s a look.
A final analysis of AstraZeneca’s Phase III POSEIDON trial shows IMFINZI (durvalumab), offered improvements in overall survival (OS) when added to tremelimumab and chemotherapy versus chemotherapy alone in patients with Stage IV (metastatic) non-small cell lung cancer.
The FDA released a briefing document that expressed concerns over ChemoCentryx’s avacopan. Company shares plummeted 46.5% at the news.
Six months after receiving Emergency Use Authorization from the U.S. FDA for COVID-19 vaccines, Pfizer/BioNTech and Moderna are planning to seek full approval for the preventative medications.
Bluebird bio reported first-quarter earnings, the approval of Abecma, the first CAR-T therapy for relapsed or refractory multiple myeloma, and its spinout, 2seventy bio, and its leadership.
Less than two weeks after receiving the greenlight for Zynlonta under accelerated approval, ADC Therapeutics has launched its treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma.