FDA
The antibody-drug conjugate, withdrawn from the market by GSK in 2022 after failing a confirmatory study, was approved Thursday by the FDA for previously treated patients with multiple myeloma. This is despite a negative advisory committee vote in July.
FEATURED STORIES
Heading into the final quarter of a year that has seen dramatic upheaval at the FDA—from the exodus of numerous senior leaders to unclear policy changes and a safety saga that engulfed the gene therapy space—drug approvals appear roughly on par with recent years.
New analysis from Jefferies shows that rare disease and cancer drugs granted the status are especially likely to be approved.
Following up on previous, dimly received issuances, a new set of ideas published by the FDA to streamline regulatory pathways for cell and gene therapies ‘for small populations’ is receiving a warmer welcome—but experts warn it will take more to turn the tide for the fraught therapeutic space.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
Elecsys’ approval could help boost the uptake of currently approved Alzheimer’s disease therapies, including Biogen’s Eisai-partnered Leqembi, with CEO Chris Viehbacher recently noting that such biomarker-based tests could “remove some of the bottlenecks” in uptake.
While a new facility setup program aimed at encouraging onshoring received a positive reception at a recent meeting, industry representatives said the current rules on existing production plants are the main regulatory issues facing manufacturing teams.
In the Phase III FIBRONEER-IPF study, Jascayd demonstrated significant lung capacity improvements over placebo.
Six months after his controversial departure from the top spot at the FDA’s biologics division, Peter Marks has landed at Eli Lilly, joining former colleague Rachael Anatol, who was ousted from the agency not long after Marks.
The hold was placed earlier this year when the FDA asked for more preclinical data, but the agency was slow to respond due to ‘strain’ on its capacity, according to Neurizon.
This latest FDA program aims to provide speedier reviews for generic drugmakers who produce their products in the U.S.
Rocket Pharmaceuticals’ strategic realignment initiative in July pulled funding from fanca-cel, which the biotech was developing for Fanconi anemia.
As with recent rejections for Biogen and Scholar Rock, manufacturing issues stymied a regulatory bid from Fortress Biotech and Sentynl Therapeutics. Fortress said the FDA did not flag problems with the drug’s safety or efficacy.
Due to policies regarding industry user fees, the FDA will not be able to accept any new drug applications for the duration of the government shutdown, according to Leerink Partners.
The first oral BTK blocker for chronic spontaneous urticaria, Rhapsido offers a more convenient treatment option for patients who still show symptoms after antihistamine treatment.