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
HOOKIPA Pharma Inc. reported recent clinical progress highlights and financial results for the second quarter ended June 30, 2019.
The new designation granted to Calquence marks the 10th such designation the company has earned since 2014, AstraZeneca said.
Pharming Group N.V. announced it has entered into a development collaboration and license agreement with Novartis to develop and commercialize CDZ173, a small molecule phosphoinositide 3-kinase delta (PI3Kẟ) inhibitor being developed by Novartis to treat patients with Activated Phosphoinositide 3-kinase Delta Syndrome.
Microbix Biosystems Inc. reports results for its third quarter and nine months of fiscal 2019, the three-month and nine-month periods ending June 30, 2019 (“Q3" & “YTD”), with record YTD sales, strong YTD sales growth, improving percentage gross margin, and progress on its strategic goals.
The Democratic senators called it “unconscionable” that AveXis and its parent company Novartis would include manipulated data in order to rush a product to market.
Sandoz’ biosimilar to Enbrel was approved in 2016 by the FDA but has remained off the market due to the patent protection surrounding Amgen’s blockbuster rheumatoid arthritis treatment.
Recce Pharmaceuticals Limited announced the European Patent Office has granted its patent applications for wholly owned RECCE® antibiotics, including lead compound RECCE® 327 furthering marketing/manufacturing monopolies and expanding clinical indications.
BioCardia®, Inc. announced that the European Patent Office has issued the Company Patent No: 3063172 for “Methods of Measuring Potential for Therapeutic Potency and Defining Dosages for Autologous Cell Therapies.”
Now that July has come and gone, the U.S. Food and Drug Administration is back to work approving drugs. This week marks three PDUFA target action dates, although one has already been rejected and another hit a snag that doesn’t appear to affect the decision date.
Before it finalizes the guidance, the FDA is seeking comment from drugmakers about the proposed plans.