Regulatory Focus™ > News Articles > Regulatory Recon: Novartis, Roche Back French Gene Therapy Startup; Pfizer to Give Patients Free Acc

Regulatory Recon: Novartis, Roche Back French Gene Therapy Startup Pfizer to Give Patients Free Access to Breast Cancer Drug as it Awaits NICE Decision (4 May 2017)

Posted 04 May 2017 | By Michael Mezher 

Regulatory Recon: Novartis, Roche Back French Gene Therapy Startup Pfizer to Give Patients Free Access to Breast Cancer Drug as it Awaits NICE Decision (4 May 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • US prescription drug spending as high as $610 billion by 2021: report (Reuters)
  • Don't hobble the FDA (Boston Globe)
  • CDRH Plots Path to New 'Progressive' Approvals for Some Devices (Focus)
  • FDA, NIH & Industry Advance Templates for Clinical Trial Protocols (Focus)
  • Senate Committee to Vote on FDA User Fee Reauthorizations (Focus)
  • Trump faces major test as vote looms on U.S. healthcare bill (Reuters 1, 2)
  • With $8 Billion Deal on Health Bill, House G.O.P. Leader Says 'We Have Enough Votes' (NYTimes) (Politico) (NYTimes) (Health Affairs Blog) (NYTimes) (Forbes)
  • Aetna CEO Predicts Obamacare Will Not Be Repealed (Forbes)
  • Bayer, J&J win first trial over Xarelto bleeding risks (Reuters)
  • Louisiana Proposes Tapping A Federal Law To Slash Hepatitis C Drug Prices (KHN)
  • The Failure of Solanezumab — How the FDA Saved Taxpayers Billions (NEJM)
  • Academic, Foundation, and Industry Collaboration in Finding New Therapies (NEJM)
  • Joe Biden and Dr. David Agus talk cancer initiative, impact of budget cuts (CBS)
  • 2017 establishes Eliquis as the blood-thinner to beat (EP Vantage)
  • Gilead's new deal scout faces tough task as investors clamor for M&A (Fierce)
  • With Pfizer's Xtandi sales slowing, analysts question $14B Medivation price (Fierce)
  • 'Right To Try' Won't Give Patients Access To Experimental Drugs. Here's What Will. (Health Affairs Blog)
  • Novartis exercises option with Conatus for NASH product (Reuters)
  • Generic-Drug Makers Want 40-State Price-Fix Suit Dropped (Law360-$)
  • How To Deter Pharma Conflict Of Interests: Have FDA, CMS Grade Cost-Effectiveness (Pink Sheet-$)

In Focus: International

  • Pfizer to give out breast cancer drug free while awaiting NHS decision (The Guardian)
  • An AI-Driven Genomics Company Is Turning to Drugs (MIT Technology Review)
  • Roche denies its acne treatment led to suicide of 21 year old (Pharmafile)
  • European Regulatory Roundup: UK Hurries Drug Pricing Bill Ahead of Election (Focus)
  • Poxel shares jump 40% after diabetes trial hits primary goal (Fierce) (Press)
  • Sosei's latest UK fishing trip hooks an RNA player (EP Vantage)
  • Novartis, Roche back French gene therapy start-up Vivet (Reuters) (Fierce)
  • EMA Launches Public Consultation on Evaluating Influenza Treatments (EMA)
  • EMA Consults on Pediatric Pharmacokinetics Concept Paper (EMA)

US: Pharmaceuticals & Biotechnology

  • Drug spending by Blue Cross Blue Shield members rose 73 percent since 2010, even as generic use rose (CNBC)
  • The Next Big Breakthrough in Drugs May Be How You Take Them (Fortune)
  • New tool calculates true cost of mobile apps for pharma and healthcare (Fierce)
  • Novo Updates 2017 Guidance, Launches Xultophy (BioCentury)
  • Clovis' Rubraca Tops Early Expectations (BioCentury)
  • Is a placebo better than nothing to treat insomnia? (Reuters)
  • Warning Letters 2016 – Data Governance & Data Integrity (FDAZilla)
  • Five Industry Trends for U.S. Drug Wholesalers in 2017 (rerun) (Drug Channels)
  • After failed phase 3, Accera appoints neuroscience vet to help revive fortunes (Fierce)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Phase 3 OCTAVE Studies of Oral Tofacitinib in Ulcerative Colitis Results Published in The New England Journal of Medicine (Press)
  • Pfizer Announces U.S. FDA Filing Acceptance of Supplemental New Drug Application for XELJANZ (tofacitinib citrate) for the Treatment of Adult Patients with Active Psoriatic Arthritis (Press)

US: Medical Devices

  • Defending against medical device hacker threat, MedCrypt CEO seizes an opportunity (MedCityNews)
  • Cybersecurity task force seeks new security framework, exemption to the Stark law (Modern Healthcare)
  • FDA, Medtronic Warn on Surgical Navigation Device (Focus)
  • Proposed Legislation Seeks to Further Address the Issue of Classifying Device Accessories (FDA Law Blog)
  • Baxter looks to combination device pathway for home peritoneal dialysis machine (MassDevice)
  • Acutus Medical wins FDA nod for AcQGuide steerable sheath (MassDevice)
  • Interscope wins FDA nod for EndoRotor resection tool (MassDevice)
  • ReFlow Medical Issues Recall of Specific Lots of Wingman35 Crossing Catheters (FDA)
  • Baxter Achieves Regulatory Milestone for New Peritoneal Dialysis Technology (Press)

US: Assorted & Government

  • Guest Post – Justice for Patriots' Fans (Drug & Device Law)
  • PTAB Life Sciences Report -- Part III (Patent Docs)
  • Aetna adds Virginia to list of Obamacare exits for 2018 (Reuters)
  • How Should We Prepare For The Wave Of Retiring Baby Boomer Nurses? (Health Affairs Blog)
  • Ex-Johnson & Johnson exec wins appeal in noncompete spat with Baxter (MassDevice)
  • Louisiana medical facility sues Philips over MRI scanner issues (MassDevice)
  • Medicaid Demonstrations: Federal Action Needed to Improve Oversight of Spending (GAO)

Upcoming Meetings & Events


  • UK's MHRA issues alert over SVD issues in select Mitroflow LX valves (MassDevice)
  • £50 blood test could predict prostate cancer drug response (PharmaTimes)


  • DIA in association with US FDA to hold multicentre workshop on GCP in Mumbai and Hyderabad (PharmaBiz)

General Health & Other Interesting Articles

  • More evidence ties childhood obesity to type 2 diabetes in kids (Reuters)
  • Understanding The History Behind Communities' Vaccine Fears (NPR)
  • Unfounded Autism Fears Are Fueling Minnesota's Measles Outbreak (NPR)

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? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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