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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
Although that is good news, cancer is the second-most common cause of death in the U.S., with more than 1.7 million new cancer cases each year and more than 600,000 cancer deaths. The report notes that one of the biggest factors in decreased cancer rates are lower tobacco smoking rates.
On Jan. 11, President Donald Trump announced via Twitter that 2018 was marked by a decline in prescription drug prices – the first time that had happened in 50 years. Also, the president said that Americans saved $26 billion on drug prices in the first 19 months of his presidency.
The notorious legacy of OxyContin continues to be a major black mark against Purdue Pharmaceuticals. And that mark is only getting worse as a court case against the opioid manufacturer has revealed company officials used deceptive marketing practices to boost sales of the drug.
Noting that the U.S. Food and Drug Administration (FDA) expects more than 200 investigational new drug applications (INDs) by 2020 per year, many of them cell and gene therapies, the agency issued an outline of new procedures it plans to implement this year.
Office Covering the Use of MANF or CDNF as a Treatment for Glaucoma, Macular Degeneration and Retinitis Pigmentosa
CarTher today announces it has secured approval from the French National Agency for Medicines and Health Products Safety (ANSM) to start a Phase I-II clinical trial of its SonoCloud-9 device in the treatment of recurrent glioblastoma.
Eisai Co., Ltd. and Purdue Pharma L.P. today announced that a new drug application has been submitted to the U.S. Food and Drug Administration (FDA) for lemborexant, an investigational agent for sleep-wake regulation, seeking approval for the treatment of insomnia, a sleep-wake disorder.
In 2018, the FDA approved 59 novel drugs, meaning approved new molecular entities. BioSpace analyzed new drug approvals from 2014 to 2018 to determine which companies were responsible for the most drug approvals in that period. Here’s a look.
The FDA approved Cabometyx based on the Phase III CELESTIAL trial that showed the drug provided a statistically significant and clinically meaningful improvement in median overall survival.
Wave Life Sciences is working to get its nucleic acid treatment, suvodirsen, for Duchenne muscular dystrophy (DMD) approved. DMD is a rare muscle-wasting disease that affects mostly boys, about 15,000 in the U.S.