FDA
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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.
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Keytruda (pembrolizumab) won another regulatory victory, making it the first checkpoint inhibitor approved by the U.S. FDA for first line treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction carcinomas regardless of PD-L1 expression.
This morning, Janssen announced Ponvory has been greenlit as the only oral disease-modifying therapy studied against an established oral comparator for this indication.
The approval was for Arcalyst (rilonacept), a weekly, subcutaneously-injected, recombinant fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling.
The drug is a lipoglycopeptide antibiotic. It is given in a single, one-hour infusion.
EmpowerDX, a Eurofins subsidiary, just launched its direct-to-consumer COVID-19 Home Collection Kit in the U.S. through Amazon, making it one of a miniscule number of at-home and over-the-counter kits that are putting detection of the SARS-CoV-2 virus in the hands of patients.
The second half of March is a busy month for the U.S. Food and Drug Administration (FDA), with quite a few PDUFA dates scheduled. Here’s a look at this week’s target action dates.
The U.S. FDA approved AVEO Oncology’s Fotivda (tivozanib) for adults with relapsed or refractory advanced renal cell carcinoma (RCC) in people who have had two or more previous systemic therapies.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 9, 2021.
The U.S. FDA approved Gilead and Kite’s Yescarta (axicabtagene ciloleucel) for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
Roche announced it was voluntarily withdrawing the U.S. indication Tecentriq for in prior-platinum treated metastatic urothelial carcinoma (mUC) after failing to meet endpoints in confirmatory trials.