Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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It should come as no surprise that not all information on the internet is reliable. It’s a largely unregulated wild, wild west that allows for anyone to put up any content they wish to. Which can be a particular problem when it comes to health-related content.
The proposed study is intended to support the global registration of balixafortide. Polyphor expects to enroll the first patient in the second quarter of 2019.
The year 2018 saw a number of significant triumphs in the biopharma industry – increased numbers of drug approvals and near record-shattering IPOs, but the industry also saw its share of blemishes and black eyes from various corners of the globe.
Novartis’ gene therapy treatment for spinal muscular atrophy could see approval as early as May of this year after the U.S. Food and Drug Administration granted AVXS-101, now dubbed Zolgensma, priority review.
Shareholders raise concern over the fairness of the reverse merger and question potential conflicts of interest of OvaScience’s co-founder.
A report from the Government Accountability Office said the FDA failed to live up to the legal requirements when approving drugs under a rare disease designation.
Many of these directors do not publicly disclose their affiliation with the pharma companies in their nonprofit biographies, report shows.
Francis Collins, director of the National Institutes of Health (NIH) and the scientist who led the Human Genome Project, weighed in on the recent case of He Jiankui.
Intellipharmaceutics International Inc. today announced that it has submitted an investigational new drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for its oxycodone hydrochloride immediate release (“IPCI006") tablets in the 5 mg, 10 mg, 15 mg, 20 mg and 30 mg strengths.
- FDA PDUFA goal date remains tomorrow, November 28, 2018