Regulatory
Akari Therapeutics, Plc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for nomacopan for the treatment of hematopoietic stem cell transplant associated thrombotic microangiopathy (HSCT-TMA) in pediatric patients.
Company Outlines Roadmap to Develop Successful Therapies for Neurodegenerative Diseases Based on its Broad Anti-Tau Clinical Pipeline
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.
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.
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