Food and Drug Administration (FDA)
NEWS
If the road to success is paved with failures, then the road to an effective, approved drug is paved with flops. Merck and Enanta are adding some painful pavers to their own roads this week.
The extension will give the FDA sufficient time to look into the drug for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
Iterum Therapeutics will head back into the clinic to meet regulatory requirements to refile a New Drug Application for oral sulopenem.
The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a negative trend vote on the company’s Marketing Authorization Application for Aduhelm.
The research showed that 61% of patients with PV experienced a complete hematological response after 7.5 years of treatment with BESREMi. Here’s more about it.
If bentracimab continues to yield the desired results through the rest of the Phase III study, PhaseBio will be on track to file a Biologics License Application in mid-2022.
Between January 4, 2020 and October 30, 2021, COVID-19 accounted for 576 deaths among children 17 and younger, compared to 189 from influenza, according to the CDC.
The study was momentous in that it was the first head-to-head comparison of two modalities. The Aimovig showed significantly good results and aced primary endpoints.
Regeneron Pharmaceuticals announced more positive findings from its ongoing Phase III trial on the use of REGEN-COV to prevent COVID-19 in uninfected persons who have been exposed to the virus.
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