FDA
Vinay Prasad, the FDA’s Center for Biologics Evaluation and Research head, is accused of interpersonal impropriety as pushback builds against his decision to reject Moderna’s influenza vaccine candidate.
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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AstraZeneca and Daiichi Sankyo’s breast cancer therapeutic Enhertu received supplemental approval for an earlier form of breast cancer from the U.S. Food and Drug Administration.
Two biologic therapeutic candidates have met their primary endpoints in phase III trials, including AstraZeneca’s Champion-NMOSD trial and Argenx’s Advance trial.
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
The FDA has approved two of Phathom Pharmaceuticals’ products for bacterial illnesses in adults: Voquezna Triple Pak and Voquezna Dual Pak.
The FDA accepted Bayer’s supplemental New Drug Application for its proposed oral treatment for metastatic hormone-sensitive prostate cancer.
Orphalan announced the FDA has granted full approval to Cuvrior (trientine tetrahydrochloride) for the treatment of Wilson’s Disease, a rare genetic disorder.
Hutchmed failed to secure FDA approval for its proposed drug for pancreatic cancer. The company will have to go through another trial if they want U.S. approval.
Notably, Qelbree is the first novel FDA approval of a novel non-stimulant treatment for ADHD in adults in 20 years.
Shares of Praxis Precision Medicines are falling after the company announced the FDA has placed a clinical hold on the company’s IND Application for its experimental epilepsy drug, Prax-222.
AbbVie is off to a strong start for 2022 driven by success from Skyrizi and Rinvoq, as well as the company’s neuroscience platform. Abbvie also won FDA approval for a new indication for Rinvoq.