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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Assertio Therapeutics, Inc. announced that the United States Court of Appeals for the Federal Circuit has ruled in favor of Assertio with respect to the company’s patent litigation against three filers of Abbreviated New Drug Applications for the NUCYNTA® franchise.
Cystic fibrosis drugmaker Vertex was forced to destroy nearly 8,000 packs of its drug Orkambi after the medication had expired before they could be shipped to the United Kingdom due to a contentious pricing fight.
BioSpace takes a quick look at some of the news coming from biotech and pharma companies from across Europe and Asia.
On March 26, AbbVie announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved its Skyrizi (risankizumab) for plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adults who haven’t responded to conventional therapies.
First Latin American Approval of Crysvita, the only Treatment that Targets the Underlying Cause of this Rare, Hereditary, Lifelong Disease
Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business, announced that it has acquired marketing approval for Revcovi 2.4 mg for intramuscular injection [Elapegademase] from the Ministry of Health, Labor and Welfare .
Embattled Purdue Pharma has agreed to pay $270 million to settle a lawsuit brought against the company over the marketing of its opioid painkiller OxyContin, according to reports.
Numerous top biopharma executives met recently in Manalapan, Florida for the R&D Leadership Summit. Although a wide range of topics were discussed, certain areas rose to the top as being of particular concern to industry leadership. Here’s a look at a few of those concerns.
Today, Celgene submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its ozanimod for adults with relapsing forms of multiple sclerosis (RMS).
Falsified Data Forces Duke to Pay $112 Million Settlement, Other Universities Under Scrutiny as Well
Duke University has agreed to pay the U.S. government more than $112 million to settle allegations that a university-associated researcher falsified claims in order to obtain funding from the National Institutes of Health and other federal agencies.