FDA
With a greenlight for ibogaine to enter clinical testing and three unnamed products set to receive Commissioner’s National Priority Vouchers this week, it’s full speed ahead for psychedelics. But will sidestepping normal regulatory protocols actually be a net negative for the field?
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BioSpace looks back at 2025 and where the FDA is going in 2026.
The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more forthcoming about the details of agency decisions in their own disclosures, according to biopharma and regulatory analysts.
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The EUA was granted base on interim data from the Phase III COMET-ICE trial in high-risk adult outpatients.
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.