Theranos Settles Investor Suit as Funds Run Low (WSJ)
Million-person genetic study finds gene patterns linked to how long people stay in school (MIT Tech Review)
Analysts Expect Drug Supplier Whiplash To Endure on Rebate Changes (Bloomberg)
In lawsuit, Human Longevity alleges that Craig Venter stole trade secrets (STAT)
In Focus: International
Sangamo Bags TxCell, and a Next-Gen Cell Therapy Tech, for $84M (Xconomy) (Fierce) (GEN)
Chinese authorities to carry out surprise checks on vaccine makers, as Premier Li Keqiang calls for severe punishment (The Straits Times) (Reuters) (The Guardian)
Cambrex to Acquire Halo Pharma, Adding Drug Development and Finished Dosage Capabilities to Global API Manufacturing Network (Press)
Bristol-Myers Squibb Announces Departure of Chief Commercial Officer (Press)
Isogenica Licenses CIS Display Technology to Aro Biotherapeutics for Centyrin-based Biopharmaceutical Development (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
Top Alzheimer’s researchers hope that near-100 dementia drugs in trials are moving closer to a breakthrough (CNBC)
Amneal Announces FDA Approval and Launch of Generic Potassium Chloride Oral Solution (Press)
Aerie Pharmaceuticals Announces Early Notification of FDA Acceptance of NDA Submission for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% with PDUFA Date Set for March 14, 2019 (Press)
Acceleron Announces Preliminary Results from Part 1 of the ACE-083 Phase 2 Trial in Patients with Charcot-Marie-Tooth Disease at the 2018 Annual Meeting of the Peripheral Nerve Society (Press)
Alnylam Presents New Analyses of Clinical Results from APOLLO Phase 3 Study of Patisiran at 2018 Peripheral Nerve Society Annual Meeting (Press)
Aura Biosciences Presents Interim Phase 1b/2 Data at the American Society of Retina Specialists (ASRS) Annual Meeting (Press)
Alzheon Presents New Findings in APOE4/4 Homozygous Patients with Mild Alzheimer’s Disease, Further Supporting Precision Medicine Approach and Planned Confirmatory Clinical Trial with ALZ-801 (Press)
Medical Devices
House panel to vote today on medical device tax repeal (MassDevice)
Repeal of medical device tax would support medical technology innovation (The Hill)
A tax on medical devices makes no sense. It’s time to eliminate it for good (STAT)
MITA urges Congress to permanently repeal the medical device tax (MITA)
MIT, Harvard Face New Challenge to Gene-Editing Patent (Bloomberg-$)
Medical Devices Are Going Mobile, but Makers Face Barriers (Bloomberg-$)
NIH Clinical Center releases dataset of 32,000 CT images (NIH)
Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency’s continued commitment to postmarket review of Essure and keeping women informed (FDA)
MEDICALgorithmics, Medi-Lynx Receive FDA 510(K) Clearance for PocketECG CRS Mobile Cardiac Rehabilitation System (Press)
US: Assorted & Government
A move to undermine women’s reproductive health (The Hill)
Senate set to confirm Wilkie for Veterans Affairs secretary (AP News)
Sniffles? Cancer? Under Medicare Plan, Payments for Office Visits Would Be Same for Both (NYT)
70 Democrats Sign On to New ‘Medicare for All’ House Caucus (The Daily Beast)
FDA’s Product Jurisdiction Proposal: More Changes are Needed (FDA Law Blog)
Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments (FDA)
Regulatory Perspectives on Otic and Vestibular Toxicity: Challenges in Translating Animal Studies to Human Risk Assessment; Public Workshop (FDA)
Anthem In Telehealth Deal With Samsung And American Well (Forbes)
One Man’s $50 Billion Vendetta Against Opioids (Bloomberg)
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.
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