FDA Rejects Push for New Regulatory Action on Medical Device Service (AAMI) (Focus) (Medtech Insight-$)
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Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine (JAMA)
Bioverativ and Sangamo Announce FDA Acceptance of IND Application for Gene-Edited Cell Therapy BIVV003 to Treat Sickle Cell Disease (Press)
Fate Therapeutics and Memorial Sloan Kettering Cancer Center Expand Scope of License Agreement to include Gene-edited T-cell Immunotherapies (Press)
Insmed Announces FDA Acceptance for Filing of New Drug Application for ALIS in NTM Lung Disease Caused by MAC (Press)
Albireo Enrolls First Patient in Phase 3 PFIC Trial of A4250 (Press)
Audentes Announces Continuing Positive Data from First Dose Cohort of ASPIRO, a Phase 1/2 Clinical Trial of AT132 in Patients With X-Linked Myotubular Myopathy (Press)
Stryker’s Howmedica owes $13m in fees in Zimmer Biomet patent spat (MassDevice)
'Program Alignment' Turns 1: FDA Wants To Train Investigators On Innovative Tech As Part Of Its Inspection Scheme – But Will It Be A Cakewalk? (Medtech Insight-$)
iSTAR's Glaucoma Micro Device Shines In Early Follow-Up (Medtech Insight-$)
Sivantos and Widex in $8 billion merger to create No.3 in hearing aids (Reuters)
Sivantos-Widex allows EQT to reset the clock (EP Vantage)
Keys To FDA Advisory Panel Prep For Device Makers (Law360-$)
MC10 Receives FDA 510(k) Clearance for the BioStamp nPoint System (Press)
FDA Clears CASMED’s FORE-SIGHT Tissue Oximetry OEM Module (Press)
Medtronic Begins U.S. Study of Drug-Eluting Stents to Evaluate Treatment of Bifurcation Lesions in Patients with Coronary Artery Disease (Press)
DePuy Synthes Signs Definitive Agreement to Acquire Assets of Medical Enterprises Distribution, LLC to Strengthen its Portfolio and Amplify the Surgeon's Capabilities Via Automation (Press)
US: Assorted & Government
Verily submitted patent application for smart diaper able to detect, differentiate between waste (MobiHealthNews)
Pennsylvania Appeals Court Affirms Preemption of State Law Claims Based on Off-Label Marketing (FDA Law Blog)
Blue states can defend ACA in latest lawsuit, judge says (Axios)
Which drug makers’ medicines are racking up bigger and bigger bills for Medicare and Medicaid? (STAT-$)
Johnson & Johnson to relaunch baby-care line after its 20% sales decline (CNBC)
A bid to save $300 million at HCR ManorCare, and disrupt U.S. healthcare (Reuters)
Pennsylvania To Lead Nation In Medical Marijuana Research (Forbes)
Elliott Says Athenahealth Isn't Engaging in Takeover Talks (Bloomberg)
International Mail Facilities: ORA Letter to the USPS (FDA)
Fixing Healthcare: Driving Value Through Smart Purchasing and Policy (HHS Secretary Alex Azar)
Amgen Receives European Commission Approval For Repatha (Evolocumab) To Prevent Heart Attack And Stroke In Adults With Established Cardiovascular Disease (Press)
GE increases cell culture media production capacity by tenfold (Press)
Philips and Dutch Rijnstate hospital sign 10-year agreement to build a virtual hospital for large-scale connected care (Press)
Suicide Became the Second Leading Cause of Death for Young People in 2016. We Don't Know Why (Fortune)
Survey: Nine out of ten doctors worry about negative online reviews (MobiHealthNews)
Why EHR data interoperability is such a mess in 3 charts (HealthcareITNews)
Trump’s Plan for Cheaper Health Insurance Could Have Hidden Costs (NYT)
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].
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