Regulatory Recon: Ohio Drug Pricing Ballot Initiative Fails; NICE Rejects Bayer's Stivarga for Liver Cancer (8 November 2017)

Posted 08 November 2017 By Michael Mezher

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

In Focus: US

  • FDA Commissioner Talks About His Tenure, Recruiting And LDTs (Medtech Insight-$)
  • Ohio's Drug Pricing Ballot Initiative Fails (Cleveland) (STAT) (NYTimes)
  • Trump wants to cut Pharma's tax bill, but what are drugmakers actually paying? (STAT)
  • House punts med device tax until after tax reform is finished (MassDevice) (Washington Examiner)
  • FDA chief: Keep defense medical approvals in our sphere (The Hill) (Fierce)
  • What's Driving Health Care Costs Up In The US (Forbes) (JAMA)
  • Regeneron profit, revenue beat on Eylea, Dupixent sales (Reuters)
  • Advances in Sequencing Likely to Shift Paradigm in Cancer Drug Approvals, FDA Experts Say (Focus)
  • You Can Get Your DNA Tested At An NFL Game. Should You? (NPR)
  • US senators press Allergan for details on patent deal with tribe (Reuters) (CNBC)
  • Did Allergan lose its $2.1B Kythera bet, or can chin-fat drug Kybella make its mark? (Fierce)
  • New cancer therapies come with big risks. Drugmakers must be prepared (STAT)
  • DEA Wants Feds To Grow Almost 1,000 Pounds Of Marijuana Next Year (Forbes) (DEA)
  • Who are the top 10 players that dominate the cancer drug market? And who's growing fastest? (Endpoints)

In Focus: International

  • Novartis takes fight to Pfizer's Ibrance with new Kisqali data (Reuters)
  • NICE turns down Bayer's Stivarga for liver cancer (PharmaTimes)
  • WHO seeks new director for cancer agency facing US scrutiny (Reuters)
  • Struggling GSK recruits cancer drug guru Hal Barron as its new R&D chief (Endpoints)
  • Lupin aims to resolve quality issues highlighted by FDA in 12-15 months (Nikkei Asian Review)
  • Amid US Challenges, Will Glenmark's R&D Pipeline Deliver? (SCRIP-$)
  • Valeant's Turnaround Is Still a Work in Progress (Bloomberg) (Financial Times)
  • Why Mallinckrodt's Woes Matter to All Drug Makers (WSJ)
  • German biotech InflaRx raises $100M in IPO (Endpoints)
  • Asia Regulatory Roundup: China Strengthens Supervision of Online Drug, Device Sales (Focus)
  • Abbott's Generic Pharmaceutical Business To Continue Growth Led By Emerging Markets (Forbes)
  • MDMA or MDNR: Which Saudi Arabian Registration Route is Better for Low-risk Medical Devices? (Emergo)
  • Reaching global HIV/AIDS goals: What got us here, won't get us there (PLOS)
  • CHMP Recommends One Generic, Extends Indications of 6 Drugs (EMA)
  • 17,000 English patients are surviving Stage 4 cancer for two years or more, new data shows (Pharmafile)
  • Emerging generic API hubs unlikely to challenge India and China, says analyst (InPharma)

Pharmaceuticals & Biotechnology

  • Spark Hints At Price For Luxturna (BioCentury) (Endpoints)
  • Boehringer gets deeper into NASH, RNA with MiNA pact (Fierce) (Press)
  • Should 'Female Viagra' Have Ever Been Approved? (Fortune)
  • Pazdur Skeptical Of Separate Geriatric Oncology Trials (Pink Sheet-$)
  • FDA Finalizes Guidance on Antiviral Drugs for Cold Sores (Focus)
  • FDA Seeks Input on Analysis Data Reviewer's Guide for Drug Submissions (Focus)
  • Five Prime Shares Dive on Latest Hiccup For Cancer Immunotherapy Combos (Xconomy) (Endpoints)
  • With $40M for Exonics, Duchenne's Gene Therapy, CRISPR Race Heats Up (Xconomy)
  • Amgen bets on stem cell company Fortuna Fix in $25M round (Endpoints) (Fierce)
  • Pfizer Staph Vaccine Trial May Support Claim For Some, But Not All, Orthopedic Surgeries (Pink Sheet-$)
  • Kerrisdale predicts failure for Prothena rare disease medication in short attack (Fierce) (Endpoints)
  • OTC painkillers treated painful injuries just as well as opioids in new study (LA Times)
  • Record haul of drugs collected at DEA event, officials say (CBS)
  • Clinical trials still have a problem with ethnic minorities (Pharmafile)
  • HIV-1 persistence following extremely early initiation of antiretroviral therapy (ART) during acute HIV-1 infection: An observational study (PLOS)
  • Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • GSK files Nucala for COPD (PharmaTimes)
  • OncoSec shares turn hot as microcap reports promising PhII data for an I/O one-two punch (Endpoints)
  • Sanofi And Regeneron To Present New Analyses From The Praluent® (Alirocumab) Injection Odyssey Clinical Trial Program At The AHA Scientific Sessions 2017 (Press)
  • iVeena Delivery Systems Receives FDA Orphan Drug Designation for IVMED-80 for the Treatment of Keratoconus (Press)
  • Cinfa Biotech presents additional data for pegfilgrastim biosimilar candidate B12019 (Biosimilar News)
  • Millendo Therapeutics Announces Positive Topline Phase 2 Results of ATR-101 in Classic Congenital Adrenal Hyperplasia (Press)
  • Seattle Genetics and Astellas Initiate Phase 1b Trial of Enfortumab Vedotin in Combination with Immune Checkpoint Inhibitor Therapies in Locally Advanced or Metastatic Urothelial Cancer (Press)
  • Synlogic Reports Positive Top-Line Phase 1 Data Demonstrating Safety and Tolerability and Proof of Mechanism in Healthy Volunteers for SYNB1020, a Synthetic BioticTM Medicine for the Treatment of Hyperammonemia (Press)

Medical Devices

  • Journal Editors Should Encourage Disclosures of CDRH's Role in Trial Designs: JAMA Viewpoint (Focus)
  • Roche ALK Test Gains FDA Approval as CDx for Alecensa (GenomeWeb) (Press)
  • Second Sight Receives FDA Expedited Access Pathway Designation for the Orion Cortical Visual Prosthesis System (Press)
  • Report: Q3 medical device recalls down 39% (MassDevice)
  • FDA approves Axonics IDE trial for r-SNM neuromod (MassDevice)
  • Q&A: How to Prepare for an AI-Driven Future (MDDI)
  • Penumbra's Q3 results top estimates (MassDevice)
  • Nevro shares fall as Q3 losses rise (MassDevice)

US: Assorted & Government

  • FDA Warns Night Clubs on Laserworld, Ray Technologies Laser Risks (FDA)
  • Voters in Maine approve expansion of Medicaid under Obamacare (Reuters)
  • Wisconsin lawsuit blames drug makers for opioid crisis (Chicago Tribune)
  • Scope of opioid lawsuits widens to include hospital accreditor (STAT)
  • Allergan executives named in investor suit over alleged generics price fixing (Fierce)
  • Chuck Norris Lawsuit Claims MRI Agent Poisoned His Wife (Forbes)
  • USPTO Issues Final Rule Establishing Patent Agent Privilege (Patent Docs)
  • A Second Look at Eye-Drop Litigation (Drug & Device Law)
  • Philips, Zoll Medical close in on settling AED patent spat (MassDevice)
  • Price Transparency And Physician Quality Report Card 2017 (Altarum)
  • Medicaid Chief Says Feds Are Willing To Approve Work Requirements (KHN) (NYTimes)
  • Gottlieb Statement on a practical approach to ensuring timely implementation of FDA's menu labeling rule (FDA)

Upcoming Meetings & Events

Europe

  • Transcatheter aortic valve implantation (TAVI) in patients at intermediate surgical risk (EUnetHTA)
  •  Overseas recruitment essential to NHS, say trust chiefs (PharmaTimes)
  • Legionnaires' disease in Lisbon hospital kills two, 32 infected (Reuters)

Asia

  • FDA Warns Chinese Firm for Confusing API in OTC Drug (Focus)
  • China FDA to review application for Lenvima in liver cancer (PharmaLetter)

India

  • FDA approves Sun Pharma's Coreg CR generic (DSN)
  • Gujarat FDCA to train drug inspectors on cGMP, GLP in collaboration with UL (PharmaBiz)
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General Health & Other Interesting Articles

  • Drug Hunters: Meet the Scientists Building a Library of Designer Drugs
  • With online medical marijuana, it's buyer beware (Reuters)
  • Cutting back on alcohol can prevent cancers: experts (Reuters)
  • Parental exposure to hazardous agents tied to eye tumors in offspring (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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

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

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