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.
Fujifilm Holdings Corp. has bagged the Japanese Pharmaceuticals and Medical Devices Agency (PMDA)’s approval for CXR-AID, its artificial intelligence (AI) powered chest X-ray analysis system developed in collaboration with Lunit Inc.
The FDA said it has withdrawn the accreditation of Accelerated Device Approval Services LLC (ADAS), of Miami, for making false presentations about one of the company’s employees. Among the allegations are that the company named a reviewer who was never employed by ADAS, and that the company misled a client about the status of a regulatory filing.
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.
The FDA’s pre-IND response to Virpax Pharmaceuticals Inc.’s MMS-019, a molecular masking spray being developed as an over-the-counter product to limit transmission of SARS and influenza, has the company breathing easier and ready to chase an NDA. Virpax is in a crowded field of 43 COVID-19 intranasal therapeutics and vaccine programs.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neoteryx, Roche.
An update from China’s NMPA clarifying registration requirements and classification methods for drug-device combination products has been welcomed by industry as the regulator seeks to keep pace with fast-moving developments in the sector.
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