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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Fitzgerald resigns four months after ex-HHS Secretary Price.
Here is a look at a few important regulatory events scheduled for the month of February.
Celltrion are down more than 5 percent after the company announced it received a warning letter from the FDA after the regulatory agency inspected a company drug manufacturing facility.
The bill would allow access to experimental treatments for patients with terminal conditions.
The company is now waiting for the FDA to determine a path forward in resuming clinical studies.
The SEC filed a suit against “one or more unknown traders” while it seeks to identify the perpetrators.
The FDA will establish a council to oversee all animal studies under the agency’s purview.
Despite some safety concerns such as severe diarrhea, the FDA approved Puma’s breast cancer drug Nerlynx in July 2017.
The negative trend vote from the CHMP will likely mean the EMA will not authorize neratanib for extended adjuvant treatment of early-stage HER2-positive breast cancer.
Significant risk remains for companies that cannot move quickly enough to positively impact R&D productivity and for those that encounter challenges in accessing technology and expertise that likely lie outside their organization.