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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Following Purdue Pharma’s Chapter 11 filing last month, other opioid makers are exploring ways to settle their own litigation problems by participating in the OxyContin drugmaker’s bankruptcy proceedings.
The U.S. Food and Drug Administration (FDA) rejected the company’s inhaled triple-combination therapy, PT010, now known as Breztri Aerosphere.
Janssen’s Invokana snagged another regulatory approval to reduce the risk of end-stage kidney disease, cardiovascular death and worsening of kidney function in adults with type 2 diabetes and diabetic kidney disease.
On Monday, the House Republican resigned his congressional seat ahead of the expected plea.
Synairgen plc, the respiratory drug discovery and development company, announces its unaudited interim results for the six months ended 30 June 2019.
The payment of USD 14.3 million corresponds to the USD 11.6 million in damages plus interest awarded to Adocia in August 2018 by an American Arbitration Association Panel presiding over Adocia’s arbitration claims against Eli Lilly
Oklahoma was the first state to file suit against opioid manufacturers. The success of their legal strategy will have a significant impact on the opioid–and pharmaceutical–industry going forward.
International precision medicine firm Lucence Diagnostics announced that it has received the Clinical Laboratory Improvement Amendments certification for its laboratory in Singapore from the U.S. Department of Health and Human Services’ Centers for Medicare & Medicaid Services.
Cygnus Technologies, a Maravai LifeSciences company, announced that it has achieved ISO 9001:2015 certification.
Studies on a novel protein that helps cancer cells to grow and spread may help in the development of more efficient therapies for liver cancer