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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A prostate cancer drug jointly developed by healthcare giant Bayer and Finland-based Orion can slow the spread of the disease, according to late-stage study results announced early Wednesday.
The FDA, as well as other government agencies, have expressed alarm at the rate of opioid-related overdoses in the United States – an issue that has become an epidemic across the heartland.
Abdul Rahman bin Mohammed Al Owais, UAE Minister of Health and Prevention, signed a partnership agreement with Leif Johansson, Chairman of leading global pharmaceutical company AstraZeneca, as part of its strategy to enhance the outcomes of national indicators in the field of respiratory diseases and cancer, to achieve the objectives of the National Agenda 2021.
Smart services to be showcased include electronic sick leave attestation, online permits for imported drugs, ‘Sanad &Rahma’ & electronic birth and death certificates
The American University Washington College of Law and the Food and Drug Law Institute hosted a conference late last week. One of the highlights was a plenary session that featured former commissioners of the U.S. Food and Drug Administration (FDA).
The FDA approved Sanofi and Regeneron’s Dupixent (dupilumab) as an add-on maintenance therapy for patients with moderate-to-severe asthma. The approved group is age 12 years and older with either an eosinophilic phenotype or with an oral corticosteroid-dependent asthma.
Regeneus Ltd is pleased to announce it has received a Notice of Intention to Grant a European patent covering the use of Progenza by the European Patent Office.
Anticipated Funding Opportunities for Fiscal Year 2019 (FY19)
Quark Venture Inc. has petitioned the British Columbia Supreme Court to overturn an unfavourable arbitration award concerning its decision to deny further investment to MSI Methylation Sciences, Inc. (“MSI”).
This week will have moderate activity by the U.S. Food and Drug Administration (FDA). Although they jumped the gun on Regeneron and Sanofi’s cancer drug, there are still plenty of other decisions being made this week. Here’s a look.