Regulatory Recon: Vertex Three Drug Cystic Fibrosis Combos Beat Expectations FDA Approves Gilead's Vosevi for 2nd Line HCV Treatment (19 July 2017)

Posted 19 July 2017 | By Michael Mezher 

Regulatory Recon: Vertex Three Drug Cystic Fibrosis Combos Beat Expectations FDA Approves Gilead's Vosevi for 2nd Line HCV Treatment (19 July 2017)

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

In Focus: US

  • New Vertex drugs show dramatic gains for tough-to-treat cystic fibrosis patients (STAT) (Forbes) (Fierce) (Financial Times) (Endpoints) (WSJ) (Boston Globe) (Reuters) (Press)
  • FDA approves Gilead's drug for chronic hep C patients (Reuters) (Endpoints) (Medpage) (FDA)
  • How the Senate Health Care Bill Failed: GOP Divisions and a Fed-Up President (NYTimes)
  • Gottlieb: FDA to Issue new Policies to Streamline Generic Reviews in 2017 (Focus) (FDA Law Blog)
  • Drug pricing spotlight shifts to generics with no rivals (EP Vantage)
  • Generics Advocates Suggest Improvements To Hatch-Waxman At Public Hearing (BioCentury)
  • Brands Push Back Against REMS Reform, Call Problem Small With Burdensome Fixes (Pink Sheet-$)
  • FDA Exploring Whether Public Shaming Can Stop REMS Abuses (Pink Sheet-$)
  • Senate Appropriations Bill Maintains FDA Funding for 2018 (Focus)
  • Me-too drugs with limited benefits — the tale of regorafenib for HCC (Nature)
  • Biotech M&A? Novartis chief Jimenez says he's sticking to the under-$1B aisle for now (Endpoints)
  • BIO lobbies lawmakers for new rules that expose biotech short sellers (Endpoints)
  • What are you taking? Most-prescribed drugs across the nation last year (STAT)
  • Poor test results for Roche cloud growth prospects (Reuters)
  • Latinos Left Out Of Clinical Trials … And Possible Cures (KHN)
  • Safeway to pay $3 million to resolve U.S. drug probe (Reuters)
  • Congress Squares Off Over Drug Pricing And A Controversial Drug Discount Program (KHN) (Pink Sheet-$)

Sponsored Content: IVDR/MDR Challenges Top Roadshow Agenda

In Focus: International

  • China Adds Blockbuster Drugs to Insurance List After Price Cuts (Reuters)
  • EU nod for Gedeon's novel antipsychotic Reagila (PharmaTimes)
  • Speedy EU Assessment On Cards For AZ's Durvalumab (SCRIP-$)
  • China FDA Clears Cstone To Start Trials Of Anti-PD-L1 mAb (BioCentury)
  • Asia Regulatory Roundup: Pfizer, Sanofi Raise Concerns on TGA Complementary Medicine Proposal (Focus)
  • UK underperforming in cancer care compared to Europe, according to ABPI report (Pharmafile)
  • £325 Million Invested in NHS Transformation Projects (UK DoH)
  • Gaza health care suffers as Palestinian factions play blame game (Reuters)
  • Mosquitoes less likely than people to spread disease via air travel (Reuters)
  • Canadian pharmaceuticals market set for steady growth to $25 billion by 2021 (PharmaLetter-$) (Report)
  • Russian chamber of commerce warns of drug shortages due to low pricing (PharmaLetter-$)
  • Merck's new health charity strikes partnership deal with Tanzania (PMLive)

Pharmaceuticals & Biotechnology

  • CAR-T Cell Therapy Is Here To Stay (Forbes)
  • Novartis Mulls Outcome-Based Price For Car T Therapy (BioCentury)
  • FDA Names Wood Chief Counsel (BioCentury)
  • More Than CAR-T: Hematologic Oncology Pipeline Offers Rich Menu Of Possible Approvals (Pink Sheet-$)
  • When The Drug You Need Doesn't Make Money (Forbes)
  • Report: Biopharmaceutical Therapies in Clinical Development (PhRMA)
  • When It Comes To Abusive Drug Pricing, Don't Confuse Shkreli With Hep C Drugs (Forbes)
  • Remicade is ready to fend off biosim No. 2, Johnson & Johnson executives say amid Q2 revenue miss (Fierce)
  • Pfizer hires Catalent to make smaller format Advil using Optigel tech (InPharmaTechnologist)
  • Lupin recalls 12,480 bottles of anti-depressant drug from US (Economic Times)
  • USPSTF Stays Course on Ovarian Cancer Screening (Medpage)
  • Sharing Data for 21st Century Cures – Two Steps Forward… (Harvard Bill of Health)
  • Shire pens bispecific hemophilia R&D deal with Novimmune (Fierce) (PharmaTimes)
  • Kleo taps PeptiDream for help with immuno-oncology programs (Fierce)
  • Lilly firms up Adimab R&D alliance, bringing its Ab platform in-house (Fierce)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Researchers plot a course into PhIII after another Alzheimer's drug flunks a key test (Endpoints) (Fierce)
  • StratGraft's Skin Treatment Gets New FDA Regenerative Med Status (Xconomy)

Medical Devices

  • Virtual Reality Will Change Medtech—Once It Clears These 5 Hurdles (MDDI)
  • Guided Therapeutics re-opens FDA discussions seeking LuViva PMA (MassDevice)
  • EDAP pulls FDA bid for Focal One, plans to resubmit with new data (MassDevice)
  • Voluntis wins regulatory nod to integrate Toujeo insulin with Insulia mobile app (Drug Delivery)

US: Assorted & Government

  • Senate Republicans reluctantly consider bipartisan healthcare talks (Reuters)
  • The 3 Republicans Who Doomed a Senate Repeal of the Health Law (NYTimes)
  • GOP Failure To Replace The Health Law Was Years In The Making (KHN)
  • McConnell says Senate to vote early next week on Obamacare repeal (CNBC)
  • Hurt by a drug? You can file suit in California if a clinical trial took place there (STAT)
  • Leveraging FDA Resources to Encourage Students to Pursue STEM Careers (FDA)
  • Ex-FDA Head's Comments May Put Meningitis Cases In Peril (Law360-$)
  • Latest testimony in Shkreli trial centers on a Retrophin stock deal gone sour (Endpoints)
  • As Obamacare repeal falters, insurers start to press on subsidies (Reuters)
  • Illinois law requires coverage of pediatric autoimmune disorders (Reuters)
  • Employee alleges Teva hid DOJ antitrust probe in lawsuit (Drug Delivery)
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on the Funding Awards to States for FDA Food Safety Modernization Act (FSMA) Produce Safety Implementation (FDA)
  • Amounts Billed Do Not Indicate Fair Market Value In FCA Case (Drug & Device Law)
  • Millennium Pharmaceuticals, Inc. v. Sandoz Inc. (Fed. Cir. 2017) (Patent Docs)

Upcoming Meetings & Events


  • Life expectancy increases in Britain beginning to stall: report (Reuters)
  • GSK to sell Horlicks as part of strategic review (Financial Times)


  • Zydus Cadila launches anti-ulcer drug in US (Economic Times)
  • Hetero Set To Join Indian Humira Biosimilar Line-Up (SCRIP-$)
  • India Mulls Contentious Move To All 'Vegetarian' Pharma Capsules (Pink Sheet-$)
  • Aurobindo Pharma gets USFDA nod to market kidney ailment drug (Economic Times)
  • Cadila's new MD Sharvil Patel aims to double revenues in 5 years (Economic Times)
  • MtaI appeals to govt to bring medical devices under 5% GST slab (PharmaBiz)
  • ICMR releases revised draft National Guidelines for Stem Cell Research, 2017 (PharmaBiz)


  • Japanese firms pair up for development of regenerative medical product using DPCs (PharmaLetter-$)

Other International

  • Flagship Russia/Nicaragua vaccines project runs into trouble (PharmaLetter-$)

General Health

  • Lost Mothers: Maternal Mortality in the US (ProPublica)

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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