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.
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There were two issues the agency had. First, the FDA wanted the inclusion of two animal studies to evaluate whether the drug caused thickening of the heart valve. The second was more of a goof—the contract research organization Zogenix employed uploaded the wrong data set for the application.
A recent study conducted by the Milbank Quarterly found that the FDA followed the guidelines of the scientific advisory committees 78% of the time. To come to that conclusion, researchers examined public documents from FDA advisory committee meetings and medical product databases for all FDA advisory committee meetings from 2008 through 2015.
MorphoSys AG will publish its first six months’ 2019 results on August 6, 2019 at 10:00pm CEST.
Galapagos NV announces its unaudited first half-year results, which are further detailed in its H1 2019 report available on the Galapagos website, www.glpg.com.
sterna biologicals selected as one of a group of top-tier European biotech companies to present at the European Biotech Investor Day on August 1, 2019 in New York City
Net sales increased 10 per cent compared to Q2 2018, corresponding to the net of acquisitions and discontinuing operations.
Delivered 31% increase in revenue, 51% increase in operating profit and 60% increase in net profit year-on-year Delivered 21% increase in revenue, with increases in operating profit and net profit compared to Q1 2019 Increased investment in pipeline to support long-term growth
FGFR inhibitor gains FDA approval based on 40% response rate in MD Anderson-led Phase II trial
It is the first and only nasally-dosed glucagon, which is indicated for diabetic patients undergoing a severe drop in blood sugar. Previously it was only administered by a complicated injection system.
Horizon Discovery Group plc, a global leader in the application of gene editing and gene modulation technologies, provides a trading update for the six month period ended 30 June 2019.