Policy
Maintaining America’s momentum demands that policymakers resist policies that undermine research and development incentives.
FEATURED STORIES
The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
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.
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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.
Both Bayer and J&J claim the lawsuits are without merit but believe that the $775 million settlement will allow the companies to move on from costly litigation.
A U.S. Food and Drug Administration (FDA) advisory panel voted 14 to 0 against recommending Neuronix’s NeuroAD system for the treatment of mild to moderate Alzheimer’s disease.