Regulatory

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.
Sareum Holdings PLC, the specialist small molecule drug development business notes that Sierra Oncology, the licence holder advancing clinical cancer candidate SRA737, has announced its financial and operational results for the second quarter 2019 ended 30 June 2019.
Esperion provided bempedoic acid franchise development program updates and financial results for the second quarter ended June 30, 2019.
Neos Therapeutics, Inc. reported financial results for the second quarter ended June 30, 2019 and provided a business update.
Catalyst Pharmaceuticals, Inc. reported financial results for the second quarter ended June 30, 2019 and provided a corporate update.
Global Blood Therapeutics, Inc. reported recent business progress and financial results for the second quarter ended June 30, 2019.
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