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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An international team of scientists have confirmed that both rare and common mutations of our genes are linked to the development of breast cancer, including tumour characteristics and corresponding deadliness.
Abu Dhabi National Exhibitions Company (ADNEC) is set to host a series of leading international events in its venues in Abu Dhabi and Al Ain during November 2018, covering key economic sectors such as Oil & Gas, real-estate, Investment and healthcare.
Unique technology set to play a key role in the rapidly emerging gene therapy market
Eight initiatives shortlisted from 33 initiatives presented by 24 government entities
Texas-based Pain Therapeutics is urging the FDA to reconsider the Complete Response Letter it issued in August for the company’s opioid-treatment, Remoxy. Representatives from Pain Therapeutics will meet with the FDA on Jan. 31. 2019 to discuss the request, the company announced late Monday.
On Friday, the FDA approved Merck’s Keytruda, an anti-PD-1 therapy, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with the chemotherapy drug sorafenib.
Clinical data for a fish-oil-based drug from Amarin Corporation PLC confirmed the drug’s ability to reduce the relative risk reduction of adverse cardiovascular events by 25 percent, including a 20 percent reduction in cardiovascular death.
Move part of effort to increase awareness and educate about preventive measures
The U.S. Environmental Protection Agency (EPA) has settled with two California companies for failing to provide required notifications for the handling of toxic chemicals.
The Food and Drug Administration is taking care of a few approvals and committee meetings ahead of the Thanksgiving holiday week. They include drugs for COPD, a pain drug, and a sublingual film formulation of a well-known drug for erectile dysfunction. Here’s a look.