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 Chinese scientist living abroad who has been accused of accepting stolen intellectual property to benefit a pharma startup in China has been extradited to the United States.
This is a list of new molecular entities and new therapeutic biological products approved by the agency’s Center for Biologics Evaluation and Research in 2019.
Three months after it won approval in type 2 diabetes, AstraZeneca’s Farxiga is eying potential regulatory win as a treatment in heart failure patients.
“We are pleased that the FDA recognized Molgradex as a breakthrough therapy for the treatment of aPAP, a debilitating rare lung disease with no approved pharmacologic treatment options,” said Rob Neville, Savara’s chief executive officer.
Company will present at Biotech Showcase™ 2020 on Monday, 01/13/20 at 11:15am PST in San Francisco, CA
AstraZeneca and Merck are closing out 2019 on a high note with another approval for its PARP inhibitor Lynparza.
Over the course of 2019, there have been numerous reports that show the increasing price of the medication is keeping it out of reach of patients. Some lawmakers are placing the blame squarely on the shoulders of drugmakers.
The Shenzhen Nanshan District People’s Court sentenced He today to three years in prison and a fine of 3 million yuan ($430,000 U.S.). Two other medical researchers, Zhang Renli and Qin Jinzhou, worked with He and were also sentenced.
The clinical trials the approval is based on suggested the drug was effective for treating primary insomnia but may also be effective for insomnia associated with other diseases, such as depression.
Specifically, it was approved for adults with unresectable or metastatic HER2-positive breast cancer who have had two or more previous anti-HER2-based treatments in the metastatic setting.