Policy
The $1.2 trillion budget package will now move to the Senate, which is expected to hold a vote next week.
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 US 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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
The jury found the company failed to warn patients of a side effect causing young men who used the drug to grow breasts (gynecomastia).
Successful review of HEMOBLAST Bellows’ performance and safety profile as well as Biom’up’s Quality Management System by the Australian Therapeutic Goods Administration (TGA)
Acorda Therapeutics’ attempt to preserve its patent protection for multiple sclerosis drug Ampyra hit the proverbial wall Monday when the U.S. Supreme Court refused to hear the company’s appeal of a lower court ruling.
The approval of Beovu was based on findings from the Phase III HAWK and HARRIER clinical trials, in which Novartis’ drug demonstrated non-inferiority versus Eylea in mean change in best-corrected visual acuity at 48 weeks.
The proposal, which is similar to a prescription drug plan put forth by House Speaker Nancy Pelosi last month, also aims to boost new federal investments in drug development and manufacturing.
On Friday, Holmes’ attorneys from the firm Cooley LLP, who are representing her in a civil lawsuit brought against Theranos and Walgreens, filed a motion with the courts to withdraw from the case over Holmes’ failure to pay them for their work.
There are several scheduled PDFUA dates for the U.S. Food and Drug Administration over the next two weeks. Here’s a look.
The approval was based on data from the Phase III GRECO clinical trial and the Phase I AMES trial.
The only other drug currently approved in the U.S. for HIV PrEP is Gilead’s Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg).
Trump said that the pharma industry was looking for payback due to his administration’s efforts to lower the costs of prescription drugs.