Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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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.”