Regulatory Recon: Trump Labels Opioid Crisis a National Emergency; FDA Warns of Deaths With Intragastric Balloons (11 August 2017)

Posted 11 August 2017 By Michael Mezher

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

In Focus: US

  • Trump labels opioid crisis a 'national emergency' (Politico) (NYTimes) (Reuters)
  • Q&A: FDA wants to (computer) model the way to better, data-driven clinical trials (STAT)
  • The cost of treating opioid overdose victims is skyrocketing (STAT)
  • FDA Warns of Gastric Balloon Deaths (Medpage) (FDA) (Apollo)
  • GSK abandons Ionis' FDA-ready inotersen as new CEO sweeps out rare disease efforts (Endpoints)
  • NantHealth cuts staff, offloads assets as Q2 losses hit $70M (Fierce) (Endpoints)
  • A New Heart Disease Test Flings Color Genomics Into A Battle About Genetics In Medicine (Forbes)
  • Stealthy Viruses Take Center Stage In Efforts To Transplant Pig Organs Into People (Forbes) (MIT Technology Review)
  • Federal Circuit Dismisses Amgen Appeal on Pfizer's Epogen Biosimilar (Focus) (Patent Docs)
  • FDA Planning For Possible Doubling Of HQ-Based Staff In 15 Years (Pink Sheet-$)
  • ICER's Ambitious 2018 Review Agenda Takes On Groundbreaking Treatments (Pink Sheet-$)
  • Here's why Sucampo paid $200M for its PhIII Niemann-Pick drug (Endpoints) (NIH)
  • Gilead circles February 12 on its calendar as D-day for its HIV franchise (Endpoints)
  • Ohio AG: This is why I'm suing five opioid manufacturers in my state (Washington Post)
  • Feds pull Mylan, a small-time opioid drugmaker, into industrywide marketing probe (Fierce)
  • The 2017 report card so far: Big Biotech largely trading up as pharma posts mixed results (Fierce)
  • Pharma's giants, new and old, tell more tales than their numbers show (Fierce)
  • By the Numbers: The Real Opioid Death Rate (Medpage)
  • A 'Vaccine For Addiction' Is No Simple Fix (NPR)
  • To Speed Access To Compassionate Use, Look Beyond The FDA (Health Affairs Blog)
  • The generic drug market 'is at risk now' from deflation, trade group says (CNBC)

Sponsored Content: FDA Recommendations for Cybersecurity in Life Sciences

In Focus: International

  • New Research Compares Drug Regulators Around the Globe (Focus)
  • Speech given by Lord O'Shaughnessy on Brexit and medicines regulation (MHRA)
  • Canadian court OKs Stryker's $700m Novadaq buy (MassDevice)
  • £2m UK consortium to tackle gene therapy (PharmaTimes)
  • German Regulators Slam Dr. Reddy's Plant for Critical, Major Deficiencies (Focus)
  • European Regulatory Roundup: EMA Revises Pharmacovigilance Guideline After Danish Agency Spots 'Big Problem' (Focus)
  • Advanced therapy medicinal products fastest growing area of biopharma, says report (Pharmaceutical Journal)
  • CFDA Proposal Would Require Chinese Translations of Foreign Medical Device Applicants' Company Information (Emergo)
  • Mexico Introduces New Pharmacovigilance Guidelines (Pink Sheet-$)
  • Italy Opens Up ADR Database To The Public (Pink Sheet-$)
  • The 'New' Vifor Pharma: Focused On Specialty Pharma (SCRIP-$)
  • Intas eyes Teva's oncology, women's health divisions in Europe (Economic Times)

Pharmaceuticals & Biotechnology

  • Novartis veteran David Epstein takes leadership role at Rubius (Endpoints)
  • Orchard Therapeutics hires ex-PTC executive Mark Rothera as new CEO (Fierce)
  • RNA-targeting CRISPR could yield treatments for Huntington's, ALS (Fierce)
  • FDA Updates on PharmaTech Recall (FDA)
  • Dicerna escalates war with Alnylam over RNAi secrets, claiming its rival wants a monopoly (Endpoints)
  • How much is living a pain-free life worth? Economists say up to $145 per day. (CNBC)
  • Ending the era of $100,000 cancer drugs (Pharmafile)
  • Takeda taps Texas startup for 'double whammy' cancer immunotherapies (Fierce)
  • Could a Trump-mandated cash repatriation spur pharma M&A, or just share buybacks? (Fierce)
  • The Future Of Value-Based Payment—Time To Reexamine And Refocus Our Efforts (Health Affairs Blog)
  • Another Study Ties Pioglitazone to Bladder Cancer Risk (Medpage)
  • Lupus Market Snapshot: There's No Debate It's A Blockbuster Opportunity (SCRIP-$)
  • CAR T cells in glioblastoma (Nature)
  • Searching in the immune checkpoint black box (Nature)
  • Inhibiting ROCK in neuroblastoma (Nature)
  • FDA Warns on Lack of Sterility Assurance for Vital Rx Drugs (FDA)
  • ICER Backs Survival Assessment Of Novartis, Kite CAR TS (BioCentury)
  • How Can You Take Part in Clinical Research? Looking Beyond "First in Human" (NIH)
  • NIH to host workshop on advances, future needs in human microbiome research (NIH)
  • Breakthrough method yields trove of neuron subtypes, gene regulators (NIH)
  • International Laboratories, LLC Issues Voluntary Nationwide Recall of One (1) Lot of Pravastatin Sodium Tablets USP, 40mg Packaged in Bottles of 30 Tablets Due to Mislabeling NDC # 54458-925-16; Lot # 115698A (FDA)
  • Pravastatin Sodium Tablets by International Laboratories: Recall – Mislabeling (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Gilead Announces U.S. FDA Priority Review Designation for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV (Press)
  • Galapagos to take IPF drug into late-stage trial after phase 2 win (Fierce)
  • Heron's post-surgery painkiller swoops into Phase 3 (BioPharmaDive)
  • TherapeuticsMD Provides TX-004HR Regulatory Update (Press)
  • Phase 2b Results of Viamet's Oral VT-1161 for the Treatment of Recurrent Vulvovaginal Candidiasis Presented at IDSOG Annual Meeting (Press)

Medical Devices

  • How to Navigate the Changing Device Manufacturing Landscape Through Financing (MDDI)
  • MIT researchers developing device to pump drugs to the brain (Drug Delivery)
  • Philips closes $2B Spectranetics acquisition (MassDevice)
  • AdvaMed goes social with anti-medtech tax ad (MassDevice)
  • Conservative groups jump on medical device tax repeal bandwagon (MassDevice)
  • FDA Clears iCubate System, Bloodstream Infection Assay (GenomeWeb)
  • Class 1 Device Recall Zenith Alpha Thoracic Endovascular Graft (FDA)
  • Renovis Surgical Receives FDA Clearance for 3D-Printed Posterior Lumbar Interbody Fusion Systems (Press)

US: Assorted & Government

  • Trump taunts Senate over repeal failure (Politico)
  • Suggestions For A Bipartisan Approach On Health Care (Health Affairs Blog)
  • On Health Care, Who Needs Congress? (NYTimes)
  • Making America Healthy Again: Analyzing Trump's Take On The Social Determinants Of Health (Health Affairs Blog)
  • CVS and Walgreens are sued over 'clawbacks' on prescription co-pays (STAT)
  • Allergan Again Pressures FDA On Restasis Generics (Law360-$)
  • Acorda Asks Fed. Circ. To Undo Nix Of Ampyra Drug Patents (Law360-$)
  • OCR's 'wall of shame' just cracked 2,000 data breaches. Here's how reporting has changed since 2009 (Fierce)
  • Compensatory Damages Allowed to Stand in Depakote Trial, Despite Adequate Warnings and Lack of Warnings Causation (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • Marketing authorisations granted in July 2017 (MHRA)
  • Parallel import licences granted in July 2017 (MHRA)

    India

    • Third Time Lucky? Sun's Ampyra Generic Appears On Course To Indian Debut (SCRIP-$)
    • Indian pharma explores Artificial Intelligence to reduce costs & speed up drug to market (PharmaBiz)
    • Cipla to supply swine flu drug to Gujarat govt based on product license clearance from Goa FDA (PharmaBiz)

    Australia

    • Heparin and Lignocaine ampoules (Pfizer) (TGA)

    Canada

    • Notice - The Regulatory Enrolment Process (REP) Functional Pilot for eCTD Format - Stage III (Health Canada)

    General Health & Other Interesting Articles

    • How Machine Learning Is Helping Neuroscientists Crack Our Neural Code (MIT Technology Review)
    • Scientists create the first mutant ants (Washington Post)
    • Widowed Early, A Cancer Doctor Writes About The Harm Of Medical Debt (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 news@raps.org.

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

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