Opioid Makers, Blamed for Overdose Epidemic, Cut Back on Marketing Payments to Doctors (ProPublica)
Jaguar Health (NASDAQ: JAGX) Subsidiary Napo Pharmaceuticals and RedHill Biopharma Enter U.S. Co-Promotion Agreement for Mytesi, Napo's FDA-Approved Drug Product (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
Newly discovered protein could boost hunt for drugs to treat sepsis and other inflammatory diseases (Fierce)
Sarcoma expert George Demetri grades the latest statement on Nanobiotix’s late-stage drug NBTXR3 (Endpoints)
Little Arsanis steers its only clinical-stage therapy to the scrap heap after a PhII implosion (Endpoints)
ReWalk Announces Progress in Clinical Study of ReStore Powered Exo-Suit (Press)
InflaRx Receives IND Approval from the FDA to Start its Phase II Clinical Trial of IFX-1 in ANCA-Associated Vasculitis (Press)
BRACAnalysis CDx Identifies Patients Who Respond to Lynparza in SOLO-1 Study (Press)
Medical Devices
Consumer DNA Testing Poses Risk for Life Insurers, Moody’s Says (Bloomberg)
Philips inks 11-year deal for patient monitoring as a service (Fierce)
Fresca Medical lands de novo authorization for Curve positive airway pressure system (MobiHealthNews)
Medtronic wins $472m cardio device DoD contract (MassDevice)
Study: Leadless pacers lead to less complications (MassDevice)
Kent Imaging inks wound care imaging deal with SerenaGroup (MassDevice)
Medtronic Launches the MiniMed(TM) 670G System Performance Guarantee for Payers and Employers (Press)
LabCorp and Philips collaborate on digital pathology to enhance the efficiency of pathology diagnostics (Press)
US: Assorted & Government
U.S. jury orders DaVita to pay $383.5 million in wrongful death lawsuits (Reuters)
Alexion Submits Application for Approval of ALXN1210 as a Treatment for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) in the European Union (EU) (Press)
Asia
AI ambulances and robot doctors: China seeks digital salve to ease hospital strain (Reuters)
C-Bridge hands Nuance Biotech $35M, opening doors to more China licensing deals (Endpoints)
Australia wins landmark WTO ruling on plain tobacco packaging (Reuters)
MA welcomes medicines shortages legislation in Australia (The Pharma Letter)
How Australia’s largest pharmacy group protects customer medical record and data (OpenGov)
Novaliq’s NovaTears Treatment for Evaporative Dry Eye Disease is Now Available across Australia and New Zealand (Press)
Canada
Drug Pricing in Canada • Aging and HIV • A Biotech Beats Goliath (Bloomberg)
Google sister-company Sidewalk has a secret 'yellow book' with its plans to reinvent cities, plus possible sites beyond Toronto (CNBC)
Drug makers in Canada disclose doctor payments as transparency debate heats up (The Globe and Mail)
General Health & Other Interesting Articles
Feeling poorly? The app will see you now (Reuters)
Health care start-up says A.I. can diagnose patients better than humans can, doctors call that 'dubious' (CNBC)
AI can make health care smarter, more cost-effective (Politico)
Subscribing to Your Patients — Reimagining the Future of Electronic Health Records (NEJM)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work. Need to contact the editor of Regulatory Reconnaissance? Email us at [email protected].
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
We have completed our migration to a new platform and are pleased to introduce the updated site.
What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.
We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.