AzurRx BioPharma and Mayoly Spindler Announce MS1819-SD Investigational Medicinal Product Dossier…
This IMPD has been submitted through the EMA clinical trial portal for approval prior to opening of clinical centers in France. Source: BioSpace
$710M Gamble Fails as Celgene Terminates Two Phase III Trials
Celgene is scrapping a late-stage Crohn's disease drug it acquired in a $710M deal three years ago following an interim data analysis. Source: BioSpace
FDA Releases New MAPP on Reviewing Packaging Drug Master Files
The FDA updated its staff manual on Chemistry, Manufacturing and Controls reviews of drug master files for packaging materials. Source: Drug Industry Daily
Lawsuit Claims Drugmakers Paid Bribes That Funded Attacks on U.S. Troops in Iraq
A group of Iraq War veterans and their families filed a lawsuit this week accusing several drugmakers of contributing to servicemembers’ deaths by indirectly funding militias in Iraq. Source: Drug…
FDA Issues Draft Bioequivalence Guidances for 30 Drugs, Revises 17
The FDA published new product-specific draft guidances for 30 active ingredients — including cancer therapies, asthma treatments, epinephrine auto-injectors and anti-infectives — outlining the agency’s preferred methods for supporting ANDA…
FDA Posts Updated Inspection Manual Chapter
The FDA recently updated its Investigations Operations Manual chapter on inspections of domestic and international sites. Source: Drug Industry Daily
Weeks After Buying ReShape Medical for $38M, EnteroMedics Bags $61M
EnteroMedics recently filed with the SEC that it had raised $61M in a new equity financing round. There were 13 anonymous investors. Source: BioSpace
Arcturus Rockets on New Hep B RNA Deal With Johnson & Johnson
Shares of Arcturus are up nearly 15 percent in Thursday morning trading after the company inked a collaboration agreement with Janssen Pharma to develop a hepatitis B drug program. Source:…
Here is the One Biotech Billionaire Investors Love
WalletHub recently examined the quarterly filings of hedge funds to determine which stocks they’re buying the most. Source: BioSpace
Pfizer Quietly Takes Passive Stake in This Boston Pharma
Shortly after Rhythm made its public debut on the Nasdaq Exchange, Pfizer has snapped up a small percentage of the company focused on treating rare genetic disorders that lead to…
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