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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David Johnston, the former chief financial officer of AVEO Oncology, was found guilty of misleading investors about the company’s kidney cancer drug, Tivozanib. Under new leadership, AVEO aims to seek U.S. approval for its kidney cancer drug early next year.
Although the recent mid-term elections had a historic changeover of control in the House of Representatives from the GOP to the Democrats, at least one change in the U.S. Senate has the biopharma industry on edge. Sen. Chuck Grassley (R-Iowa) will take over as head of the Senate Finance Committee.
Ultragenyx Pharmaceutical Inc. today announced that it has completed a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) and plans to submit a New Drug Application (NDA) to the FDA for UX007 for the treatment of patients with long-chain fatty acid oxidation disorders (LC-FAOD) in mid-2019.
Lower-Profile Thoracic Endovascular Aortic Repair (TEVAR) Device Broadens Treatable Patient Population with Thoracic Aortic Disease
After announcing a potential snag with the European Commission last month, Takeda said this morning that it received clearance for its acquisition of Shire. The clearance is conditional on addressing overlaps in the companies’ inflammatory bowel disease businesses.
Seven African American seek unspecified damages over allegations of discrimination at Charleston, S.C. facility.
The Biotechnology Industry Organization (BIO) published the fifth edition of the Building the Bioeconomy report recently. The report studied 28 different indicators and provided analysis and insight into the biotech environment for 33 countries. The goal of the report is to determine how successful biotechnology sectors can be created and sustained.
Retrophin, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for a new formulation of Thiola (tiopronin) in the treatment of cystinuria.
People with asthma have more treatment choices than ever before and the FDA recently announced approval for the readmittance of Primatene Mist – an over-the-counter epinephrine inhaler.
“Yoga is the most popular complementary health approach in the United States - used by 14.3% of the adult population, or 35.2 million people”, according to a statement published on Centers for Disease Control and Prevention (CDC) website on November eight quoting National Health Interview Survey (NHIS).