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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• Three Congolese doctors arrested in connection with WHO official's death (Reuters)

• 23andMe had devastating news about my health. I wish it hadn’t come by email (STAT)