Regulatory Focus™ > News Articles > 2019 > 2 > Recon: Medicare Proposes Coverage for CAR-T Therapies; Bayer Options Full Rights to Loxo’s Vitrakvi

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

Posted 15 February 2019 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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 $120M to settle Avanir's Nuedexta marketing probe (Fierce)
  • House committee to hold hearing on US measles outbreak (The Hill)
  • The latest Instagram influencer frontier? Medical promotions. (Vox)
  • Explainer: Low vaccination rates, global outbreaks fuel US measles spread (Reuters)
  • Health-Care Investors Prosper When Markets Quiver (Bloomberg)
  • ‘Bring back our #ChildHoodDiseases,’ White House official’s wife says as she criticizes vaccines (Washington Post)
  • Facebook, Facing Lawmaker Questions, Says It May Remove Anti-Vaccine Recommendations (Bloomberg)
In Focus: International
  • World Health Organization Forms Committee To Guide Editing Of Human Genes (NPR)
  • Bayer gains full Vitrakvi rights from Eli Lilly's Loxo (Reuters) (Press)
  • Italy proposes the WHO set international standards for drug-pricing transparency (STAT)
  • Canada Decides Against Suffix-Based Biologics Naming System (Pink Sheet-$)
  • 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)
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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-$)
Upcoming Meetings & Events Europe
  • Assets liquidated – an unhappy Valentine for Teesside crook (MHRA)
  • Medicine mailing man sentenced for illicit supply (MHRA)
  • Apply for a licence to market a medicine in the UK (MHRA)
  • Takeda issues 500 billion yen bond (PharmaLetter-$)
  • 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-$)
General Health & Other Interesting Articles
  • 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)
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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