Regulatory Focus™ > News Articles > Regulatory Recon: Pharma Spends on Lawmakers Against Medicare Part B Overhaul; GSK, AZ to Head Brexi

Regulatory Recon: Pharma Spends on Lawmakers Against Medicare Part B Overhaul GSK, AZ to Head Brexit Task Force (11 July 2016)

Posted 11 July 2016 | By Michael Mezher 

Regulatory Recon: Pharma Spends on Lawmakers Against Medicare Part B Overhaul GSK, AZ to Head Brexit Task Force (11 July 2016)

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

In Focus: US

  • Should Drugmakers Be Allowed To Avoid Taxes On Their Profits From An Alzheimer's Drug? (Forbes)
  • More than 1 million OxyContin pills ended up in the hands of criminals and addicts. What the drugmaker knew (LA Times)
  • FDA Staff Back Biosimilar to Compete With Blockbuster Humira (Focus) (Reuters)
  • Value Based Reimbursement: The Rock Thrown Into The Health Care Pond (Health Affairs Blog)
  • International collaboration to create new cancer models to accelerate research (NIH)
  • The new world of patient engagement (McKinsey)
  • Generic Drug Labels: FDA Offers Draft Guidance on Updates After Reference Products are Withdrawn (Focus)
  • The Wild West Of New Laboratory Scams (CardioBrief)
  • Share Of Specialty Drugs In Commercial Plans Nearly Quadrupled, 2003–14 (Health Affairs)
  • Carl Zimmer's Game of Genomes (STAT)
  • Merck Files DJ Complaint Against Genentech's Cabilly III Patent (Big Molecule Blog)
  • House overwhelmingly passes opioid bill (The Hill)
  • The genetic architecture of type 2 diabetes (Nature)
  • Pharma dollars went overwhelmingly to lawmakers opposing Medicare Part B overhaul (STAT)
  • Utah resident who had been infected with Zika dies: health officials (Reuters)
  • Sounds Like A Good Idea? Regulating Drug Prices (KHN)

In Focus: International             

  • GSK and AstraZeneca chiefs brought into ministerial Brexit working group (Pharmaceutical Journal) (Reuters)
  • Guideline on the clinical development of medicinal products for the treatment of HIV infection (EMA)
  • WHO Adds Three Products to Prequalified List (WHO)
  • Strasbourg, Lyon join race to snatch EMA from London after Brexit (Reuters)
  • In a big clean-up drive, government plans to scan 500 Indian drug facilities (Economic Times)
  • PRAC concludes review of Zydelig and issues updated recommendations for use (EMA)
  • Study of South Korean MERS outbreak finds 'super-spreader' patient (Reuters)

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US: Pharmaceuticals & Biotechnology

  • Procedures for CDER Medical Officer Conversion to Career-Conditional (FDA)
  • FDA Offers Guidance For Updating Some Generic Labels (Law360-$)
  • New Resource: BPCIA Legislative History Documents (Harvard Bill of Health)
  • Deuterated drug shows promise in Huntington disease (Pharmaceutical Journal)
  • GSK to work with NIH on Zika vaccine (BioCentury)
  • Zydus nabs FDA approval for type-2 diabetes drug (Pharmafile)
  • FDA approves Differin Gel 0.1% for over-the-counter use to treat acne (FDA) (Press)
  • Flu Vaccine in Pregnancy Offers Brief Protection of Babies (NYTimes)
  • New MEDDEV on European Clinical Evaluation Reports: A Broader Scope (Emergo)

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

  • Industry Expresses Concerns About FDA DTC Study (Policy and Medicine)
  • Bustling Village Apothecary, Unchained by Time (NYTimes)
  • FDA Approves First And Only Single Monthly Injection For A PCSK9 Inhibitor (Press)
  • National Academies Report Recommends Withdrawing the NPRM and Calls for a New Belmont Report (Harvard Bill of Health)
  • Nippon Kayaku PhII breast cancer candidate misses endpoint (Fierce)

US: Medical Devices

  • Class 1 Recall: Heartware Ventricular Assist Device (FDA)
  • Elizabeth Holmes Will Remain CEO, Theranos Says, But It May Stop All Lab Operations (Forbes)
  • FDA approves a dedicated syringe to be used with Humulin R U-500 insulin (FDA)
  • Information To Support a Claim of Electromagnetic Compatibility of Electrically-Powered Medical Device; Guidance for Industry and Food and Drug Administration Staff; Availability (FDA)
  • Medical Devices; Neurological Devices; Classification of the Thermal System for Insomnia (FDA)
  • Getinge Group Announces STERIZONE VP4 Sterilizer Now FDA-Cleared for Expanded Uses (Press)
  • FDA Clears Expanded Indications for Medtronic NuVent(TM) EM Sinus Dilation System with Image Guidance (Press)
  • Endonovo Therapeutics inks $22m deal for Rio Grande Neurosciences (MassDevice)
  • Tissue Analyzer 3Scan Builds Out Machine Learning With $14M Series B (Xconomy)
  • Plaintiffs lawyers bow out of Zimmer Biomet's NexGen Flex knee MDL (MassDevice)
  • FDA approves trial for Essential Medical's Manta vascular closure device (MassDevice)

US: Assorted & Government

  • The Pinnacle Hip Implant MDL Court Finally Enters Judgment (Drug and Device Law)
  • Terrorism Regulations Finish FDA's FSMA Implementation (National Law Review)
  • Big Insurers Defend $34 Billion Merger (WSJ-$)
  • Federal Circuit Says BPCIA's 180-Day Post-Licensure Notice Is Mandatory and Enforceable by
  • Preliminary Injunction (FDA Law Blog)

Upcoming Meetings & Events

Europe

  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-8 July 2016 (EMA)
  • Ipsen's CEO to step down, names new chief executive (Pharmafile) (Fierce)
  • NHS England, PTC reach agreement on Duchenne drug (PharmaTimes)
  • Nexstim wins CE Mark for brain therapy treatment for chronic neuropathic pain (MassDevice)

Asia

  • Nichi-Iko Pharmaceutical to buy Sagent in $736 million cash deal (Crain's)

India

Australia

  • Australia declares AIDS no longer public health issue (Reuters)

Canada

  • Synaptive Medical wins Health Canada nod for BrightMatter surgical imaging system (MassDevice)

Zika

  • El Salvador confirms second case of Zika-linked microcephaly (Reuters)
  • France's Valneva says has generated possible Zika vaccine (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

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