Advancing efforts from PDUFA VI, the seventh iteration of the user fee agreement negotiated between the U.S. FDA and drugmakers is intended to take patient involvement in drug development to the next level, support a new wave of biologics, and provide more tools for developing therapies and cures for rare and ultra-rare diseases.
After years of transitioning in the requirement for drug and biologics sponsors to submit applications to the U.S. FDA in the electrical common technical document format (eCTD), the agency is getting serious about the proper use of eCTD.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axsome, Beigene, BMS, GSK, Jupiter, Kalvista, Pfizer, RDIF, Ultragenyx, Valneva, Vir, Xeris, Zydus.
The FDA has approved Korsuva (difelikefalin) from Cara Therapeutics Inc. for pruritis in patients undergoing hemodialysis, following a fast review. Korsuva is the first therapy approved by the FDA in the indication and is the first ever approval for the Stamford, Conn.-based company.
The quiet cancellation of an Aug. 24 meeting in which the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) was supposed to discuss COVID-19 vaccine boosters is raising more questions about whether the Biden administration got ahead of the data with its Aug. 18 announcement that it planned to roll out mRNA booster shots to adults beginning next month.
As the U.S. House of Representatives resumes work Aug. 23 on a budget reconciliation proposal to get a $3.5 trillion fiscal 2022 budget across the finish line, many lawmakers are looking to provisions to reduce prescription drug prices as a way to pay for increased spending in other health care sectors.
Cadila Healthcare Ltd. (also known as Zydus Cadila) has received emergency use authorization (EUA) in India for Zycov-D, making it the world’s first plasmid DNA vaccine for COVID-19. Besides the adult population, the Drug Controller General of India’s nod has also given the South Asian country its first COVID-19 vaccine for adolescents ages 12 to 18.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Biontech, Covis, Fibrogen, Gilead, Hebabiz, Ortho, Pfizer, Regeneron.
The FDA has granted full approval to Pfizer Inc.’s COVID-19 vaccine in a move that is hoped will convince unvaccinated citizens that the shot is safe and effective. The mRNA vaccine, which will be branded as Comirnaty and was first developed by Germany’s Biontech SE, has been available since Dec. 11 last year under an emergency use authorization (EUA) and is the first to receive the FDA’s full endorsement.
Astrazeneca plc, en route to potentially delivering a new protection against COVID-19 for people inadequately protected by or unable to be vaccinated, has cleared a crucial hurdle with its long-acting combination therapy, AZD-7442, which met the goals of a phase III pre-exposure prophylaxis trial. The U.K.-based pharma’s readout arrived just as Regeneron Pharmaceuticals Inc. announced the MHRA’s conditional marketing authorization for its Roche Holding AG-partnered COVID-19 antibody therapy Ronapreve (casirivimab + imdevimab), also known as REGEN-COV.
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