Best Practices in Drug and Biological Product Postmarket Safety Surveillance for Food and Drug Administration Staff; Draft Document; Reopening of Comment Period (FDA)
Training Program for Regulatory Project Managers; Information Available to Industry (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
FDA Accepts Mylan’s Bevacizumab Biosimilar Application (Big Molecule Watch)
Urovant Sciences Announces U.S. FDA Acceptance of New Drug Application for Vibegron for the Treatment of Overactive Bladder (Press)
Can-Fite Updates on Clinical Milestone for its Phase III Rheumatoid Arthritis Study with Piclidenoson; Drugs Combating Rheumatoid Arthritis are Currently Introduced for the Treatment of the Coronavirus (Press)
PsiOxus Therapeutics Announces Clinical Trial with Third Cancer Gene Therapy Treatment and Appointment of New Chief Medical Officer (Press)
Medical Devices
Axonics execs bullish on breaking Medtronic market stranglehold (MedtechDive)
Exact Sciences closes takeovers of 2 cancer testing businesses (MedtechDive)
Boston Scientific settles Canadian pelvic mesh case for $21.5m (MassDevice)
Could Altair Medical’s wearable reduce opioid deaths? (MassDevice)
Aerin Medical Announces FDA Clearance and U.S. Launch of Innovative Nonsurgical Procedure for Chronic Rhinitis (Press)
Biogennix Receives FDA Clearance for Expanded Use of Agilon Moldable Bone Grafting Solution in Spine Procedures (Press)
Reflow Medical Announces 510(k) Clearance for an Expanded Indication for the Wingman Catheter to Cross Chronic Total Occlusions (CTOs) in Peripheral Artery Disease (Press)
US: Assorted & Government
Schneider, Hice, Schakowsky Introduce Bipartisan Bill To Address Medical Device Shortages (Press)
Federal Circuit Hears Argument Regarding the Denial of Genentech’s Motion to Preliminarily Enjoin Amgen’s Sales of Trastuzumab (Big Molecule Watch)
Amgen Responds to Hospira’s Motion For Rehearing En Banc of the Safe Harbor Ruling in the Epoetin Biosimilar Dispute (Big Molecule Watch)
Loeb & Loeb Picks Up DLA Piper FDA Team Head In DC (Law360-$)
Vaccine IP Under Microscope With Coronavirus Outbreak (Law360-$)
9th Circ. Says Judge Wrongly Put Warning In FDA Complaint (Law360-$)
Gilead Can't Duck Sweeping Competition Suit Over HIV Drugs (Law360-$)
Celgene Tells Justices Retroactive IPRs Are Unconstitutional (Law360-$)
Advancing Animal Models for Antibacterial Drug Development – 5 March 2020
Europe
EU Committee Gets Tough On Environmental Pharma Pollution (Pink Sheet-$)
UK looks to use Brexit to make device industry more transparent (MedtechDive)
Stada Arz now biggest foreign pharma investor in Russia (PharmaLetter-$)
‘Last Chance To Save European Innovation' (Pink Sheet-$)
Alnylam Pursues Value Framework To Accelerate Givlaari Access In EU (Scrip-$)
Janssen files for EMA approval of ponesimod in multiple sclerosis (PharmaLetter-$)
Illegal imports of medicinal products: simplified procedure proves its worth (Swissmedic)
Asia
Special Report: Before coronavirus, China bungled swine epidemic with secrecy (Reuters)
India
Industry seeks exemption for drugs manufactured for only export purposes from export restrictions (Pharmabiz)
Australia
International work-sharing initiative - Baloxavir marboxil (Xofluza) (TGA)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
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