Policy
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.
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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The U.S. Food and Drug Administration (FDA) has a few target action dates scheduled for this week, including one for Sunday, September 23, which was approved in late August.
Following AbbVie Lawsuit, Government Scrutinizes Industry-Provided Drug Educational Support Services
A federal investigation is underway into whether or not the nursing and other medical services provided by some pharmaceutical companies to doctor’s offices actually violate the law due to serving an illegal commercial service.
Incidence of Alzheimer’s disease is projected to double in the next 40 years unless a cure or preventive measures are found. The U.S. Centers for Disease Control and Prevention published a new report in the journal Alzheimer’s & Dementia projecting the disease’s likely expansion, and for the first time, forecasted the disease by race and ethnicity.
As federal lawmakers continue to wrangle over legislation to help curb the opioid crisis in the United States, the House of Representatives is showing some division over the costs that some pharmaceutical companies may have to pay for Medicare coverage.
Shares of Acadia Pharmaceuticals soared more than 26 percent in trading on Thursday and continue to climb this morning in premarket trading after the U.S. Food and Drug Administration affirmed the safety profile of the company’s lead drug, Nuplazid.
In September 2016, the U.S. FDA approved Sarepta Therapeutics’ eteplirsen, now marketed as Exondys 51, for Duchenne muscular dystrophy (DMD). And now, two years later, the European Medicines Agency (EMA) has rejected Sarepta’s application for Exondys 51.
License with Nationwide Children’s Hospital (NCH) through the Acquisition of Celenex (NCH Spinout)
Clinical data generated for submission process to be presented at international scientific congress in 2018
Additional clinical trial data for prophylaxis of HAE requested
The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL), basically a rejection, to Netherlands-based Pharming Group for its supplemental Biologics License Application (sBLA) for Ruconest.