Government
The U.S. Food and Drug Administration approved Eli Lilly’s Reyvow (lasmiditan) for the acute treatment of migraines.
In September, House Speaker Nancy Pelosi unveiled a plan to lower prescription drug prices covered by government-funded plans that include tying those medications to an International Pricing Index – a move the pharmaceutical industry opposes wholeheartedly.
The U.K. government is working to ensure adequate quantities of medications and medical devices are on hand for the transition period that will follow any form of Brexit. As for the life sciences and biotech industries – it’s become increasingly clear they face acute disruption as a result of this period of uncertainty.
Peter Embí, M.D., M.S., president and chief executive officer of Regenstrief Institute, has been named to the National Advisory Council for the Agency for Healthcare Research and Quality .
The grants were awarded through the FDA’s Orphan Products Clinical Trials Grants Program that was provided by Congress to specifically encourage the development of treatments for rare diseases.
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.
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.
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