GSK plc is preparing filings for its respiratory syncytial virus (RSV) vaccine in older people following supportive late-stage trial results, a product which could play a vital role as it spins out its consumer business arm. The vaccine could be a potential blockbuster for GSK, worth as much as $7 billion in peak annual sales if approved in all its potential uses – although trials in pregnant women remain on hold because of safety concerns.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Palette, Zavation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algo, Anaveon, Astellas, Eledon, Immunicum, Ipsen Novartis, Resvita, Roche, Sinomab, Sinovac.
The cost of providing COVID-19 vaccines and therapies for a possible fall surge in the U.S. is coming at the expense of testing and personal protection equipment. While other countries are planning for the expected surge by placing their orders for vaccines and therapies, “we are starting to lose our place in line,” White House Coronavirus Response Coordinator Ashish Jha said during a June 9 media briefing.
India’s regulators have made more moves in recent times as part of its larger and ongoing movement to regulate medical devices in its country. The Ministry of Health and Family Welfare has just finalized its regulations over the licenses of medical device manufacturers and suppliers.
The U.S. House of Representatives voted June 8 to pass the legislation reauthorizing a number of user fee programs at the FDA, a welcome bit of good news for FDA-regulated industries. Nonetheless, there are several substantive differences between H.R. 7667 and the parallel Senate bill, differences that may take some doing to overcome before a final bill can be forwarded to the Oval Office.
The Cellular, Tissue and Gene Therapies Advisory Committee scrutinized Bluebird Bio Inc.’s gene therapy elivaldogene autotemcel (eli-cel) for early active cerebral adrenoleukodystrophy (CALD) in patients without a matched sibling donor.
More than two years into the COVID-19 pandemic and nearly 18 months since a vaccine was first available for adults, the U.S. is on the cusp of having vaccines available to the youngest Americans.
The issue of life science espionage continues to reverberate across the U.S., and a new report by the Office of Inspector General (OIG) suggests that vulnerabilities in the U.S. have not been adequately addressed. The OIG report said that more than two thirds of NIH grantees failed to meet at least one requirement for investigator disclosures about their activities related to foreign entities, including governments, a problem OIG says is in dire need of a fix.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Oncologica, Medicalgorithmics, Scopio, Thermo Fisher.
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