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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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 4, 2020.
The U.S. Food and Drug Administration green-lit Roche’s new Elecsys Anti-SARS-CoV-2 antibody test that will help determine whether or not people have been infected by the novel coronavirus and developed antibodies to the disease.
The U.S. Food and Drug Administration (FDA) approved Gilead’s remdesivir under Emergency Use Authorization as a treatment for COVID-19 following reports the drug met its primary endpoint in a U.S. National Institute of Allergy and Infectious Diseases (NIAID) clinical trial.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 1, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 30, 2020.
Zejula, GlaxoSmithKline’s once-daily PARP inhibitor, won regulatory approval as a monotherapy maintenance treatment for women with advanced ovarian cancer whose disease is responsive to first-line platinum-based chemotherapy, regardless of biomarker status.
The U.S. Food and Drug Administration approved an additional recommended dosage of 400 mg every six weeks for the anti-PD-1 therapy across all adult indications, including as a monotherapy and in combination treatments.
Neurocrine Biosciences announced on Monday that it has received approval from the U.S. Food and Drug Administration for its once-daily oral drug, Ongentys, as an add-on treatment to levodopa/carbidopa for the treatment of Parkinson’s disease.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 28, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 27, 2020.