Recon: Medicare Proposes Coverage for CAR-T Therapies; Bayer Options Full Rights to Loxo’s Vitrakvi

• The Instant, Custom, Connected Future of Medical Devices (NYTimes)
• Tropical Disease PRV Fix Didn’t Stop Novartis From Winning Another (Focus)
• Appropriations Bill Would Give FDA $269M Boost Over FY2018 Budget (Focus)
• Medicare would provide national coverage for CAR-T cancer therapies under new proposal (STAT) (Reuters)
• Former CEO said he was made the ‘fall guy’ for opioid maker Insys (Boston Globe) (Bloomberg)
• Flu Vaccine Doing a Relatively Good Job This Season (AP) (STAT)
• NAFTA 2.0’s impact on drug prices is more complicated than some Democrats are implying (STAT)
• Otsuka expects to shell out $120M to settle Avanir's Nuedexta marketing probe (Fierce)
• House committee to hold hearing on US measles outbreak (The Hill)
• The latest Instagram influencer frontier? Medical promotions. (Vox)
• Explainer: Low vaccination rates, global outbreaks fuel US measles spread (Reuters)
• Health-Care Investors Prosper When Markets Quiver (Bloomberg)
• ‘Bring back our #ChildHoodDiseases,’ White House official’s wife says as she criticizes vaccines (Washington Post)
• Facebook, Facing Lawmaker Questions, Says It May Remove Anti-Vaccine Recommendations (Bloomberg)

• World Health Organization Forms Committee To Guide Editing Of Human Genes (NPR)
• Bayer gains full Vitrakvi rights from Eli Lilly's Loxo (Reuters) (Press)
• Italy proposes the WHO set international standards for drug-pricing transparency (STAT)
• Canada Decides Against Suffix-Based Biologics Naming System (Pink Sheet-$)
• Indonesia to postpone halal label deadline amid industry concerns (Reuters)
• Role of big data for evaluation and supervision in the EU (EMA)
• EMA’S PRAC Recommends Suspending Fenspiride Drugs Over Heart Rhythm Concerns (EMA)
• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 February 2019 (EMA)
• J&J and Novartis back cancer geneticist’s immunotherapy start-up (Financial Times) (Press)
• India’s generic drug maker Glenmark draws up a US-based branded drugs unit (Endpoints) (Fierce)
• Wait For Benefits Of EudraVigilance Pilot Before Expanding To More EU Products, Says Pharma (Pink Sheet-$)
• EU Cross-Country Coalition Targets New Products For Joint Pricing Talks (Pink Sheet-$)
• Swayed by discounts, NICE finally backs Roche's Perjeta for post-surgery breast cancer (Fierce) (Pharmafile)
• Alunbrig recommended by NICE for non-small-cell lung cancer (PharmaTimes)
• Deal On European SPC Manufacturing Waiver Is An Acceptable Compromise (Pink Sheet-$)
• GW Pharma's cannabis-based medicine to be tested in dementia (PMLive)
• Teva set to shed 11 manufacturing sites in 2019 (BioPharmaDive)
• FT Health: Africa’s neglected poor (Financial Times)

• The top 10 pipeline blowups, setbacks and snafus for H2 2018 (Endpoints)
• Drugmakers Debate Whether Parts of FDA’s Biosimilar Guidance are Unconstitutional (Focus)
• CDER Plots Established Conditions Pilot (Focus)
• Racial Disparities In Cancer Incidence And Survival Rates Are Narrowing (NPR)
• Monthly Round-Up of What to Read on Pharma Law and Policy (Harvard Bill of Health)
• Hurricanes, droughts, and wildfires: How biopharma is girding for climate change (STAT)
• Passage Bio Gets $116M As Wilson, Yamada Team Up On Gene Therapy Again (Xconomy)
• Nimbus brings on Janssen discovery head as CSO with plans to expand its portfolio (Fierce)
• TCR2 IPO hits midpoint, setting stage for trials of CAR-T rivals (Fierce)
• Pharmacopoeia/Industry/Agency Global Dialogue on Compendial Compliance and Harmonization Continues, with Medicine Availability at Stake (IPQ)
• James Wilson turns to old mentor for gene therapy startup’s star-studded $115M launch round (Endpoints)
• Pricing Cures For Sickle Cell Disease: Sen. Cassidy Weighs In (Pink Sheet-$)
• Checkpoint Inhibitors: US FDA Wants Consistent Adverse Event Definitions (Pink Sheet-$)
• FDA doc reveals agency charged Immunomedics with data integrity breach after August plant inspection (Endpoints)
• Bayer Sees Room For Third-To-Market Darolutamide In Prostate Cancer (Scrip-$)
• Morningside spawned Stealth Bio’s IPO stumbles out of the gate, raising $78M (Endpoints)
• Axovant sends off its small molecule team with an epilepsy drug and $100M in funding commitments (Fierce)

• Bayer stresses drug's tolerability in bid for prostate cancer market (Reuters) (Endpoints) (Press)
• FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib) as First-Line Treatment for Advanced Renal Cell Carcinoma (Press)
• Trajenta meets primary endpoint in CAROLINA trial (PharmaTimes)
• Opdivo (nivolumab) Plus Yervoy (ipilimumab) Shows Response in Pre-Treated Patients with Metastatic Castration-Resistant Prostate Cancer (Press)
• Avapritinib receives Phase III clinical trial approval for GIST in China (Press)

• DITTA Pinpoints Cybersecurity Best Practices Amid IMDRF Work (Focus)
• FDA Warns Doctor Over Unapproved Device (Focus) (FDA)
• Tandem wins interoperable claim for insulin pump from FDA (MassDevice) (FDA) (Press)
• Why I Bought My First Hearing Aids Online (Forbes)
• Bipartisan Group of Lawmakers Urge Permanent Repeal of Device Tax (Focus) (MassDevice)
• When the human factors specialist becomes the patient (Emergo)
• Corindus asks FDA for expanded neurosurgery indication for CorPath GRX (MassDevice)
• FDA green-lights early feasibility trial for Foldax’s Tria biopolymer heart valve (MassDevice)
• Titan Medical hopeful for Q4 FDA IDE trial launch for Sport robotic platform (MassDevice)
• Medality Medical™ LLC Receives FDA Investigational Device Exemption Approval for Reversal of Type 2 Diabetes Clinical Trial (Press)
• Bio-Rad Releases First FDA-Cleared Digital PCR System and Test for Monitoring Chronic Myeloid Leukemia Treatment Response (Press)
• FDA Clears Next SIG Medical AdvantageRib System (Press)

• Title X funding announcement is imminent (Politico)
• FTC wants more details on $4B Boston Scientific-BTG tie-up (MassDevice)
• Why Men In Mississippi Are Still Dying Of AIDS, Despite Existing Treatments (NPR)
• Florida Compounding Pharmacy and Its Owners to Pay at Least $775,000 to Resolve False Claims Act Allegations (DoJ)
• ‘Dancing in the streets’: Health tech leaders emboldened by U.S. plan to free up patient data (STAT)
• Reasons To Limit Inventor Testimony In Hatch-Waxman Cases (Law360-$)
• Subsys-Prescribing Doc Cops To Kickback Conspiracy (Law360-$)
• FDA Announces Various Initiatives to Increase Oversight of the Dietary Supplement Industry (FDA Law Blog)
• Game-Changing Opinion on Venue from Missouri Supreme Court (Drug & Device Law)
• Mylan Pharmaceuticals Inc. v. Research Corporation Technologies, Inc. (Fed. Cir. 2019) (Patent Docs)
• Gene-Editing Co. Cibus Delays IPO, Citing Market Conditions (Law360-$)
• Nektar Hit With Derivative Suit Over Drug Trial Results (Law360-$)

• FDA Advisory Committee Calendar
• General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee – 25-26 March 2019
• Blood Products Advisory Committee – 20-21 March 2019

• Assets liquidated – an unhappy Valentine for Teesside crook (MHRA)
• Medicine mailing man sentenced for illicit supply (MHRA)
• Apply for a licence to market a medicine in the UK (MHRA)

• Takeda issues 500 billion yen bond (PharmaLetter-$)
• FiercePharmaAsia—AstraZeneca’s China business; Pfizer Japan valsartan recall; Xofluza resistance (Fierce)

• Latest Additions to India CDSCO List of Regulated Medical Devices Include Implantables, CT Scanners (Emergo)
• Union govt urged to take urgent measures to implement PPR 2015 just as D&C Act and Pharmacy Act (PharmaBiz)
• India flooded with copycat versions of patented cancer drugs from Bangladesh (PharmaBiz)

• Consultation: Whether the TGA should publish that a prescription medicine is under evaluation (TGA)
• Upcoming changes to permissible indications for listed medicines (TGA)
• Prepare Australia for disruptive medicine, campaigning parties told (PharmaLetter-$)

• Research reveals damage that depression inflicts on brain (Financial Times)
• We should gene-sequence cave paintings to find out more about who made them (MIT Technology Review)
• Breast-density notification letters may be too dense (Reuters)