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.
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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.
David Loew, head of Sanofi Pasteur, said U.S. approval of the vaccine is an important milestone in the fight against meningococcal meningitis, a serious global health challenge that can be fatal within 24 hours.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 24, 2020.