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Regulatory Focus™ > News Articles > 2019 > 8 > Recon: CMS Finalizes CAR-T Coverage Decision; Bayer Buys Remaining Stake in Cell Therapy Co. BlueRoc

Recon: CMS Finalizes CAR-T Coverage Decision; Bayer Buys Remaining Stake in Cell Therapy Co. BlueRock

Posted 08 August 2019 | By Michael Mezher 

Recon: CMS Finalizes CAR-T Coverage Decision; Bayer Buys Remaining Stake in Cell Therapy Co. BlueRock

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Bayer to buy rest of US biotech company in rare offensive move (Financial Times) (Endpoints) (Press)
  • CMS finalizes long-sought rules for Medicare CAR-T coverage (STAT) (WSJ) (Reuters) (CMS)
  • Better Birth Control Could Exist, But It Wouldn’t Pay for Big Pharma (Bloomberg)
  • Bausch Health CEO: Big Pharma will survive US drug regulations (CNBC)
  • FDA panel backs Gilead's HIV prevention drug Descovy, except in women (Reuters) (Endpoints) (Press)
  • Sarepta shares slammed after gene therapy Duchenne MD patient was hospitalized — 6 months ago (Endpoints)
  • Novartis CEO Defends Company’s Decision to Withhold False Data From FDA (NYTimes) (Endpoints)
  • Siemens to acquire Corindus in $1.1B deal (MassDevice) (CNBC)
  • Opioid Risk Smothers Drug Stocks (WSJ)
In Focus: International
  • More research is needed to justify use of 'medicinal' cannabis: UK agencies (Endpoints) (Pharmaceutical Journal)
  • U.K. commits £250M to AI lab, seeks industry partners (Fierce) (CNBC)
  • Keytruda now available for untreated metastatic lung cancer patients via CDF (PMLive)
  • New Korean Law On Cutting-Edge Biologics Raise Hopes And Concerns (Pink Sheet-$)
  • Canadian pot company Tilray ships CBD to US for clinical trials on alcohol and PTSD (CNBC)
  • Univar’s Cufence Approved In EU For Wilson’s Disease, But Loses Orphan Status (Pink Sheet-$)
  • South Africa puts initial universal healthcare cost at $17 billion (Reuters)
Pharmaceuticals & Biotechnology
  • GW Pharma CEO: More education needed on real health benefits of drugs derived from cannabis (CNBC)
  • Daiichi Must Follow Turalio Patients For 10 Years To Assess Liver Safety (Pink Sheet-$)
  • Mail-Order DNA Tests Can Be Fun, But They Aren’t Medical Advice (Bloomberg)
  • PTC Therapeutics gears up gene therapy capacity in lease deal with Bristol-Myers (Fierce)
  • Federal Experts’ Advice On HPV Vaccine Could Leave Adults Confused (KHN)
  • Scientists' Credibility Crucial To Biopharma's Reputation (Forbes)
  • Alexandria seals $143M deal in Seattle's 'heart of the heart,' grabbing coveted land to build its biotech cluster (Endpoints)
  • Why Competition Hasn't Brought Down The High Price Of Snakebite Treatment (NPR)
  • The world’s most expensive medicine could save toddlers’ lives. But getting it is complicated (STAT)
  • Health-tech startups dream of partnering with big drug makers. First comes an intense winnowing process (STAT)
  • New exec team, new money and a big syndicate — ORIC heads to PhII (Endpoints)
  • Acadia readies new round of Nuplazid DTC as federal marketing probe continues (Fierce)
  • McKesson Playing Pivotal Role in Phase II of Friends of Cancer Research Real-World Evidence Initiative (Press)
  • NIH researchers uncover role of repetitive DNA and protein sequences in tumor evolution (NIH)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • DBV refiles peanut allergy immunotherapy in the US (PMLive)
  • Dynacure Receives Orphan Drug Designation from the US FDA for DYN101, an Antisense Medicine to Treat Rare Disease 'Centronuclear Myopathies' (Press)
  • Arrowhead Pharmaceuticals Doses First Patient in SEQUOIA Phase 2/3 Study of ARO-AAT for Treatment of Alpha-1 Liver Disease (Press)
  • Provention Bio Initiates Phase 1b/2a PREVAIL Clinical Trial Evaluating PRV-3279 in Lupus (Press)
  • KEYTRUDA's Recent Success in Triple-Negative Breast Cancer Validates I-SPY 2 Adaptive Platform Approach to Phase II Clinical Trials (Press)
Medical Devices
  • NinePoint Medical wins FDA clearance for NvisionVLE (MassDevice)
  • FDA wants more study of paclitaxel-eluting devices’ long-term safety (MassDevice) (Press)
  • Perfuze lands breakthrough designation for Millipede clot ingestion system (MassDevice)
  • This Handy New Device Might Help KO Cholera (NPR)
US: Assorted & Government
  • San Francisco Fentanyl Deaths Up Almost 150% (KQED)
  • How U.S. Healthcare Spending Per Capita Compares With Other Countries [Infographic] (Forbes)
  • FDA tells four firms to stop selling flavored e-cigarette, hookah products (Reuters)
  • Boston Scientific Wins FTC Clearance For £3.3B BTG Deal (Law360-$)
  • Brief Updates on California and Colorado Drug Price Reporting Laws (FDA Law Blog)
  • 510k Clearance Equals No Punitive Damages In Arizona (Drug & Device Law)
  • IPO Releases List of Top 300 Patent Holders for 2018 (Patent Docs)
  • Top Ethicon Doctor Defends Mesh Warnings In Calif. Trial (Law360-$)
  • Whoops! Allergan's bid to shield Botox manufacturing secrets from competitors backfires (Fierce)
  • Trump cites brother's struggles with alcohol as driving force behind fight against opioids (The Hill)
  • 'Medicare for All' complicates Democrats' pitch to retake Senate (The Hill)
Upcoming Meetings & Events Europe
  • Skills shortages ‘severely impacting’ NHS (PharmaTimes)
  • EU Warns Of Birth Defect Risks With Anti-Nausea Drug Zofran (Pink Sheet-$)
  • High-Profile EU Regulators Join Forces In Consultancy Partnership (Pink Sheet-$)
  • Further guidance note on the regulation of medicines, medical devices and clinical trials in a no-deal Brexit (MHRA)
  • List of approved countries for authorised human medicines if there is a no-deal Brexit (MHRA)
  • Guidance on handling of Decentralised and Mutual Recognition Procedures in a no-deal Brexit (MHRA)
  • Guidance on Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) in a no-deal Brexit (MHRA)
  • Licensing of biological products: biosimilars, ATMPs and PMFs in a no-deal Brexit (MHRA)
  • Regulating medical devices in the event of a no-deal Brexit (MHRA)
  • Completed Paediatric Studies - submission, processing and assessment in a no-deal Brexit (MHRA)
  • Guidance note on new assessment routes in a no-deal Brexit (MHRA)
  • Japanese filing for subcutaneous Entyvio in UC (PharmaLetter-$)
  • Not withholding interim compensation from patients who want more: Johnson and Johnson to HC (Economic Times)
  • Cutbacks Rise As Indian Pharma Tightens Control On Costs (Scrip-$)
  • Indiscriminate use of antibiotics may kill 10 million people in 2050: Delhi IPA survey (Pharmabiz)
Other International
  • Three Congolese doctors arrested in connection with WHO official's death (Reuters)
General Health & Other Interesting Articles
  • 23andMe had devastating news about my health. I wish it hadn’t come by email (STAT)
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.
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