FDA
The DC-based biopharma disputed the FDA’s conclusions regarding the data provided in its supplemental application for Hetlioz and promised to keep pushing for an approval.
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Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”
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This is the second IND to come out of the two companies’ collaboration. They will initiate a Phase I trial of the drug in cardiometabolic diseases.
When the pandemic hit, many companies diverted resources aimed at HIV to COVID-19, which ended up pausing some research efforts.
This is after Larimar reported deaths in the highest dose levels of a nonhuman primate toxicology study.
Emergent said the vaccine candidate against the mosquito-borne illness showed an increase in immune response as measured by anti-chikungunya virus SNA.
Ocugen submitted a “Master File” to the U.S. FDA for COVAXIN, the vaccine that has already received authorization in India for people ages 12 and above.
LION-101 is a novel recombinant AAV being developed as a one-time intravenous infusion for the treatment of adult and adolescent patients with Limb-Girdle Muscular Dystrophy Type 2I/R9.
The White House has also called for an independent investigation and more information from China about the pandemic’s origins.
AbbVie is aiming Skyrizi and Rinvoq at various indications to augment expected declines in the use of its $20-billion-generating-powerhouse Humira, which will lose patent protection in 2023.
NGM Bio’s aldafermin failed to hit its primary endpoint in its Phase IIB trial because of that, the company decides to shift resources to other programs.
It’s a busy week for the U.S. Food and Drug Administration, with a number of drug approvals on the calendar and an advisory committee meeting. Read on for more information.