Regulatory Recon: Uniqure to Abandon Gene Therapy in EU; Pfizer Subpoenaed Over Saline Shortages (20 April 2017)

Posted 20 April 2017 By Zachary Brennan

placeholder+image

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

In Focus: US

  • The High Cost of Prescription Drugs in the United States (JAMA)
  • HHS to Issue First Round of Opioid Grants from 21st Century Cures Act (Energy & Commerce) (HELP)
  • Trump advisers call for expanded access to treatment in war on opioid addiction (Stat)
  • Reevaluating Eligibility Criteria — Balancing Patient Protection and Participation in Oncology Trials (FDA Perspective in NEJM- $)
  • Meet the lawyer trying to pry drug pricing secrets out of Big Pharma (Stat)
  • Illumina’s Grail initiates study to advance development of blood tests to detect cancer (Press)
  • How to stop drug price gouging (NY Times-$)
  • Pfizer Hit With DOJ Subpoena Over Saline Shortages (Reuters) (Law360-$) (SEC)
  • Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2017 (FDA)
  • Top regulatory issues to watch in 2017 (Mass Device)
  • An FDA Perspective On Patient Diversity In Clinical Trials (Clinical Leader)
  • Senate Panel to Vote Next Week on FDA Commissioner (Morning Consult)
  • White House plans Obamacare showdown next week (Politico)
  • Some Republicans Think They May Have A Health Care Deal (Huffington Post)
  • Prepare for the Digital Health Revolution (Fortune)

In Focus: International

  • French regulator says up to 4,100 children victims of epilepsy drug (Reuters) (ANSM)
  • The world's most pricey drugs, from a $1.2M gene therapy to a $450K lymphoma med (FiercePharma)
  • EU crushes U.K. hopes of retaining EMA after Brexit (FierceBiotech) (BBC)
  • uniQure Announces It Will Not Seek Marketing Authorization Renewal for Glybera in Europe (Press) (Xconomy)
  • Brazil Patent Agreement Hopes To Increase Flow Of Generics To Market (Pink Sheet-$)

US: Pharmaceuticals and Biotechnology

  • New State Substitution Laws, and a Busy Spring for Biosimilars (National Law Review)
  • Medicare drug price debate puts Regeneron at risk (EP Vantage)
  • Two-horse race: Auris, Otonomy seek FDA nod for inner-ear therapies (Reuters)
  • Biosimilar Sponsors Took Delivery Device Shortcuts For Erelzi, Amjevita (Pink Sheet-$)
  • EMA-FDA QbD Pilot Program Led to Further Harmonization (Focus)

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

  • AbbVie’s PARP inhibitor fails in PhIII trials (PharmaTimes) (Press) (Endpoints)
  • Is Tesaro playing a pricing game with Zejula? Not at all, says the CEO. And here’s why (Endpoints)
  • Tesaro Resorts to PR Razzle Dazzle to Make Ovarian Cancer Drug Appear Cheaply Priced (TheStreet) (Fierce)
  • “Our Son’s Fate”: Parents Fighting for Kids’ Spine Drug Eye New Data (Xconomy)
  • CytRx Announces FDA Agreement on Regulatory Pathway to Approval for Aldoxorubicin in Soft Tissue Sarcomas (Press)
  • AbbVie's Investigational, Pan-Genotypic, Ribavirin-free Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved 99 Percent SVR(12) Rate in Chronic Hepatitis C Patients with Compensated Cirrhosis (Press)
  • Novartis v. Torrent Pharmaceuticals (Patent Docs)

Medical Devices                                

  • Medtronic Recalls StrataMR Adjustable Valves and Shunts Which May Cause Fluid Buildup in the Brain (FDA)
  • Transcript of ophthalmic devices advisory committee (FDA)
  • Diabetes Test Maker Eavesdropped In Abbott Suit, Attys Say (Law360-$)

US: Assorted and Government

  • Comment Request; Focus Groups as Used by the Food and Drug Administration (All Food and Drug Administration Regulated Products) (Federal Register)
  • Report: New FDA guidance release rate falls post-Trump election (Mass Device)
  • ImprimisRx Form 483 (FDA)
  • Trends in Use of the US Medicare Annual Wellness Visit, 2011-2014 (JAMA)
  • CDER Scheduling of WO51/1300 Conference Room (FDA)
  • FDA's Government Shutdown Plan Ready, Just In Case (Pink Sheet-$)

Upcoming Meetings and Events               

Europe

  • EudraVigilance information day (EMA)

Asia

  • Update – additional confirmed cases of anaplastic large cell lymphoma (TGA)
  • AusPAR: Nine trace elements including chromic chloride (TGA)
  • Celltrion files for approval to sell Herzuma in Japan (Big Molecule Watch)

General Health and Other Interesting Articles

  • Arkansas Court Rulings Put State’s Execution Schedule in Doubt (NY Times-$)
  • Creative Minds: Preparing for Future Pandemics (NIH Director’s Blog)
  • Cherokee Nation sues drug firms, retailers for flooding communities with opioids (Washington Post-$) (Stat-$)
  • With Drug Costs In Crosshairs, Health Firms Gave Generously To Trump’s Inauguration (Kaiser Health News)
  • 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? Send him an email at news@raps.org.

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

    Share this article:

    Categories: Biologics and biotechnology, Drugs, Medical Devices, News, US, Europe, Asia, FDA, EMA

    Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

    Regulatory Exchange: Latest Updates From the Community