Regulatory Focus™ > News Articles > Regulatory Recon: Trump Taps Lobbyist for FDA Role During Transition; Global Coalition Aims to Preve

Regulatory Recon: Trump Taps Lobbyist for FDA Role During Transition Global Coalition Aims to Prevent Future Epidemics (19 January 2017)

Posted 19 January 2017 | By Michael Mezher 

Regulatory Recon: Trump Taps Lobbyist for FDA Role During Transition Global Coalition Aims to Prevent Future Epidemics (19 January 2017)

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

In Focus: US

  • Trump taps longtime pharma lobbyist to help run FDA during transition (STAT-$)
  • Truthful and Non-Misleading: FDA Looks to Clarify Policies on Medical Product Communications (Focus) (Drug & Device Law) (FDA) (Pink Sheet-$)
  • California voters were promised cures. But the state stem cell agency has funded just a trickle of clinical trials (STAT-$)
  • Do FDA's Foreign Offices Help Keep US Drugs Safe? GAO Says Answer is Unknown (Focus)
  • Why Jay Bradner thinks Novartis can recharge drug discovery (BioPharmaDive)
  • How to Avoid a Post-Antibiotic World (NYTimes)
  • Why Patent Protection In The Drug Industry Is Out Of Control (Forbes)
  • What Trump's Libertarian Pals Don't Understand About The FDA – Or Reality (Forbes)
  • FDA Sketches Out Approach to Regulating Genome-Edited Products (GenomeWeb) (FDA Voice)
  • FDA's Approval of Generic Version of Jazz Pharma's Sleep Disorder Drug Raises Questions (Focus)
  • US Six-Month Drug Market Exclusivity Extensions Could Yield Nearly $100 Million (Health Affairs Blog)
  • How We Can Repeal The ACA And Still Insure The Uninsured (Health Affairs Blog)
  • The Republicans' Healthcare Answer -- The Purple Health Plan (Forbes)
  • Why Trump's 'Everybody' Health Plan Sounds Like Bernie's (Forbes)
  • FDA Requests Comments on Documents Related to Certain Biotechnology and Mosquito-related Products (FDA) (BIO)
  • Mystery Fungus Sparks NIH Crisis, Imperiling Trials, Patients and Its Boss (WSJ)
  • Mallinckrodt to Pay $100 Million to Settle Antitrust Allegations on Unlawful Drug Monopoly (WSJ) (DoJ)
  • Six US Senators Confronting Trump's HHS Cabinet Pick Own Health Care Stocks, Too (KHN)
  • Trump health pick defends stocks, says Americans won't lose insurance (Reuters)
  • Choice for Health Secretary Is Vague on Replacing Affordable Care Act (NYTimes)
  • Controversial patient-consent proposal left out of research-ethics reforms (Nature) (NPR)
  • Cancer reproducibility project releases first results (Nature) (Washington Post)
  • E&C Continues to Press for Accountability, Safety at Nation's Labs (E&C)

In Focus: International

  • Powerful Ideas for Global Access to Medicines (NEJM)
  • New global coalition launched to create vaccines, prevent epidemics (NYTimes) (Washington Post) (Reuters) (Nature)
  • The Q3C(R6) Step 4 presentation available now on the ICH Website (ICH) (Slides)
  • Access to one in five new drugs approved by NICE may be delayed (OnMedica)
  • Netherlands bids to hosts EU drugs agency, replacing Britain (Reuters)
  • Asia Regulatory Roundup: China Unveils Reforms to Simplify Supply Chains, Lower Drug Costs (Focus)
  • 7 Biosimilars, 2 ATMPs Among 81 Medicines That Got EMA Nod in 2016 (Pink Sheet-$)
  • Biosimilars a 'must-have' in cancer care, says ESMO president (PharmaLetter-$)
  • GSK snatches AZ Europe VP to replace exiting global head of pharma (Pharmafile) (PharmaLetter-$)
  • Counterfeit Harvoni Discovered in Nara Pharmacy, MHLW Investigating Route of Entry into Distribution (PharmaJapanWeb)
  • Ex-GSK rare disease head moves to Genenta (Fierce)
  • Why is Extensively Drug-Resistant TB on The Rise? (NPR) (Reuters)

US: Pharmaceuticals & Biotechnology

  • FDA Issues Guidance Regarding Interchangeability of Biosimilar and Biologic Drugs (Patent Docs) (Focus) (Pink Sheet-$)
  • Pfenex, Pfizer and Sandoz hail US FDA interchangeability guidelines(BioPharmaReporter)
  • FDA Issues Final Guidance Addressing Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities (FDA Law Blog)
  • Rebooted Merrimack names Sanofi Genzyme SVP as CEO (Fierce)
  • FDA Warns One Japanese, One Chinese Drugmaker (Focus)
  • CBER Announces Planned Guidance for 2017 (Focus)
  • How Precision Medicine Could Be A Lifesaver For Kids With Brain Cancer (Forbes)
  • FDA Finalizes Guidance on Assessing Abuse Potential of Drugs (Focus)
  • Faster FDA adds a positive spin to 2016's disappointing approval record (EP Vantage)
  • Alzheimer's Research: Diversity Now (LifeSciVC)
  • Interview with Janssen's Dr Amrit Ray: One Company's Efforts To Bring Order To The Challenging Area of Compassionate Use (Pink Sheet-$)
  • FDA Warns of Illnesses and Deaths in Pets Exposed to Prescription topical (human) cancer treatment: Fluorouracil (FDA)
  • PhRMA to apply big bucks to new theme in 2017 marketing campaign (Fierce)
  • Paragon Bioservices secures NIAID contract for preclinical work (OutsourcingPharma)
  • Irvine Scientific introduces xeno-free T cell growth medium (BioPharmaReporter)
  • Maryland biotechs PharmAthene and Novartis-backed Altimmune pen merger deal (Fierce)

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

  • Allergan Announces FDA Approval Of RHOFADE™ (Oxymetazoline Hydrochloride) Cream, 1% For The Topical Treatment Of Persistent Facial Erythema Associated With Rosacea In Adults (Press)
  • Opdivo (nivolumab) Demonstrated Efficacy and Improved Survival in Patients with Previously Treated Advanced Gastric Cancer in a Randomized Phase 3 Study (Press)
  • U.S. FDA Approves IMBRUVICA® (ibrutinib) as First Treatment Specifically Indicated for Relapsed/Refractory Marginal Zone Lymphoma (MZL) - a Rare Type of Non-Hodgkin's Lymphoma (Press)
  • U.S. FDA Acknowledges Receipt of Shire's New Drug Application for SHP465 for ADHD (Press)
  • Catabasis Pharmaceuticals Phase 1 Data on Edasalonexent (CAT-1004), a Potential Disease-Modifying Therapy Being Developed for Duchenne Muscular Dystrophy, Published in the Journal of Clinical Pharmacology (Press)

US: Medical Devices

  • 14 Ways That Non-Profits Contribute to the Medical Device Industry (MDDI)
  • Orthofix to pay $14 million to settle charges it paid off doctors: U.S. SEC (Reuters)
  • Class 1 Device Recall for Bard's Halo One Thin Walled Guiding Sheath (FDA 1, 2, 3)
  • Class 1 Device Recall on CareFusion Alaris Pump Module 8100 (FDA)
  • What Polymer Is Best for My New Implantable Device? (MDDI)
  • Donald Trump: 5 questions medtech needs to ask (MassDevice)
  • Biogen, Siemens Healthineers to quantify MRI analysis for multiple sclerosis (Fierce)
  • Wearable Sensors Spot Lyme Disease (IEEE)
  • Modulated Imaging Receives FDA Clearance for Ox-Imager CS System (Press)
  • Theranos Investor Claims There's A Conspiracy To Take Down Elizabeth Holmes (Vanity Fair)

US: Assorted & Government

  • New 2017 Part D Enrollment Data: Walgreens and Walmart Trounce CVS in Preferred Networks (Drug Channels)
  • New First-of-Its-Kind Study Shows Growing Share of Medicine List Prices Going to Rebates and Supply Chain (PhRMA) (Berkeley Research Group)
  • Senators demand better information from DEA on opioid campaign (Washington Post)
  • Vape companies try to galvanize Trump administration to ease FDA rules (Reuters)
  • Fish is Good for You, But Apparently, Not Too Much! (Lachman Consultants)
  • FDA Adverse Event Data Release May Mean More Lawsuits (Law360-$)
  • David Gelernter, fiercely anti-intellectual computer scientist, is being eyed for Trump's science adviser (Washington Post)
  • New Claim Of Death Emerges In Xarelto MDL (Law360-$)
  • One Foot Out the Door, Medicare Chief Launches His Own Twitter Barrage (KHN)
  • Mayor seeking to sue maker of OxyContin over opioid epidemic (CBS)
  • National Academy Of Sciences Pushes For Rescheduling Of Marijuana (Forbes)
  • Unusual Removal Situation Yields Favorable Result (FDA Law Blog)

Upcoming Meetings & Events

Europe

  • AbbVie's Humira IP strategy having 'chilling effect on competition,' UK judge (BioPharmaReporter)
  • Clinical Drug Trials submitted within the Pilot Phase to ANSM (French National Agency for Medicines and Health Products Safety) and the CPP (French Ethics Committee) (ANSM)
  • Drug Safety Update: monthly PDF newsletter (MHRA)
  • VulnerABLE: Improving the health of those in isolated and vulnerable situations (EC)
  • Edwards Lifesciences wins CE Mark for HemoSphere blood flow monitor (MassDevice)
  • Trouble At Europharma: Danish Regulators Call For New CEO (Pink Sheet-$)
  • The Qualified Person: also responsible for Distribution Activities? (ECA)
  • Servier universal CAR-T therapy outsourced to Belgian CDMO (BioPharmaReporter)
  • Medical marijuana chewing gum to treat IBS in Dutch trial (InPharmaTechnologist)

    India

    • NPPA makes registration on IPDMS mandatory for coronary stent manufacturers, importers and marketers (PharmaBiz)
    • NPPA will maintain its mandate: Minister (Economic Times)
    • Pharma industry grows 29% to Rs 2.04 lakh crore in 2015-16 (Economic Times)
    • Gujarat govt signs 249 MoUs with pharma cos attracting investments worth Rs. 15,000 cr at Vibrant Gujarat Summit (PharmaBiz)
    • Cipla arm to sell stake in Four M Propack to Shriji Polymers (Economic Times)

    Australia

    • Folate and folic acid for use in listed medicines (TGA)
    • Metformin extended release tablets (TGA)

    Canada

    • Notice to Stakeholders – Release of Guidance Documents for Consultation: Various good manufacturing practices and drug establishment licensing guidance documents (Health Canada)

    Other International

    • Do you know the Saudi GDPs? And the Role of the Responsible Person? (ECA)

    General Health & Other Interesting Articles

    • Blood pressure care in U.S. improving, but disparities remain (Reuters)
    • Migraines tied to increased stroke risk after surgery (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.


    Categories: Recon, Regulatory News

    Regulatory Focus newsletters

    All the biggest regulatory news and happenings.

    Subscribe