FDA
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
FEATURED STORIES
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
The FDA’s decision is based on positive results from several Phase III studies, including the TENAYA and LUCERNE clinical trials.
The FDA approved Kimmtrak for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma (mUM).
The FDA cited data demonstrating that both treatments are not likely to be potent against omicron and should not be authorized for use in any U.S. state, territory, and jurisdiction for the time being.
It’s a landmark no one expected or wanted — more than 70 million confirmed COVID-19 cases in the U.S. with 866,000 deaths. For that and more COVID-19 news, continue reading.
The U.S. Food and Drug Administration has approved SKYRIZI (risankizumab-rzaa), AbbVie’s proposed treatment for adults diagnosed with active psoriatic arthritis (PsA).
After receiving daily doses of the therapeutic, 71% of the children could tolerate the equivalent of 16 peanuts and six months later, 21% of them still could.
The FDA has lifted the partial hold on Kura Oncology’s KOMET-001 Phase IB trial on a potential treatment for acute myeloid leukemia.
Expanded approval for Rinvoq was based on three Phase III studies that included more than 2,500 patients. The studies met all primary and secondary endpoints.
The approval of Cibinqo was based on data from five clinical trials of more than 1,600 people. Safety and efficacy were studied in three Phase III trials.
Researchers from the Medical University of Bialystok in Poland identified a gene that appears to double the risk of severe COVID-19.