Policy
In a Cabinet meeting, Health Secretary Robert F. Kennedy Jr. said the website could go live “probably in the next 10 days,” but an exact launch date remains unclear.
FEATURED STORIES
An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
Acadia Pharma’s Catherine Owen Adams is one of the founders of a group of small- to mid-cap biotechs advocating against a ‘peanut butter blanket’ approach to drug pricing for small companies.
Former European Trade Commissioner Phil Hogan and former U.S. Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
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Cinfa Biotech today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for Pelmeg® (B12019)
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