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Regulatory Recon: Califf Says to Keep Politics Out of Science Republican Senators Propose Giving States Option to Keep Obamacare (24 January 2017)

Posted 24 January 2017 | By Michael Mezher 

Regulatory Recon: Califf Says to Keep Politics Out of Science Republican Senators Propose Giving States Option to Keep Obamacare (24 January 2017)

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

In Focus: US

  • Keep Politics Out Of Science, Says Departing FDA Chief (Forbes) (Pink Sheet-$)
  • Trump considers an entrepreneur with sweeping reform plans to run the FDA (STAT)
  • US FDA May Change Advisory Committee Planning, Member Screening (Pink Sheet-$)
  • The Fight Trump Faces Over Drug Prices (NYTimes)
  • Senators Propose Giving States Option to Keep Affordable Care Act (NYTimes) (Reuters) (Medpage)
  • Trump Abandons Trans-Pacific Partnership, Obama's Signature Trade Deal (NYTimes) (Modern Healthcare)
  • US fund managers betting Trump fails to rewrite Obamacare (Reuters)
  • Trump Signs Federal Hiring Freeze, But Impact On FDA Unclear (Inside Health Policy-$)
  • Winter Freeze Descends on Nation's Capital (FDA Law Blog)
  • Ex-FDA Commish Califf Gives Props to Patient Groups—With Caveats (Xconomy)
  • Looking Forward: The Next Generation of Biosimilars (Harvard Bill of Health)
  • Express Scripts, Cigna Opt Out of Paying for EpiPen Competitor Auvi-Q (The Street)
  • Women are gaining more board seats in biotech, but real change is happening at a snail's pace (Endpoints)
  • On Experiencing The Failure Of A Billion-Dollar Clinical Program (Forbes)
  • FTC Continues Crackdown on Pay-for-Delay Agreements (Focus) (FTC)
  • Amgen hikes prices by single digits, with Enbrel matching AbbVie's Humira boost (Fierce)
  • Andy Slavitt's next mission is saving Obamacare (Politico)
  • The Weird and Wild Gross-to-Net Adventures of EpiPen and Its Alternatives (Drug Channels)
  • Long Unsuccessful Heart Failure Drug Once Again At Center Of Controversy (CardioBrief)
  • Genetic Testing Offers New Hope for Children with Brain Cancer (MIT Technology Review)
  • Roche says FDA grants priority review for Actemra (Reuters) (Press)
  • Whither FDA? (BioCentury)

In Focus: International

  • WHO Executive Board agrees on an initial short list of candidates to the post of WHO Director-General (WHO)
  • Interviews with the candidates running for WHO director general (BMJ)
  • Merck KGaA pens pact, eyes checkpoint inhibitor combos (Fierce) (BioCentury)
  • Inovalon, Boehringer team for outcomes-based deals (BioCentury)
  • UK's MHRA Allows Early Access to Roche Bladder Cancer Treatment (Focus)
  • A Global Vaccine Injury Compensation System (JAMA)
  • Counterfeit Chinese and Indian drugs invade Africa (EurActiv)
  • AbbVie's approval application for combo hepatitis C drug set for speedy EMA review (PharmaLetter-$) (PMLive)
  • Japan biopharma firms smacked by Trump, fail to recover (BioWorld)
  • Indian pharma firm caught shredding documents at 1am by FDA (Pharmafile) (Economic Times)
  • UK's industrial strategy points to life sciences (BioCentury) (Fierce) (PMLive) (PharmaLetter-$)
  • WTO Makes Permanent a Way to Help Poor Countries Gain Access to Generics via Compulsory Licenses (Focus)
  • ICH Working Group to Provide More Detailed Guidance (Focus)
  • EDQM outlines ICH Q3D impurities testing guideline integration plan (InPharmaTechnologist)
  • Sourcing Medical Devices in China: Phase 3 – Purchase Order (Pacific Bridge Medical)
  • It's time to reduce, replace and re-think the use of antimicrobials in animals (EMA) (EMA/EFSA)
  • China jails two over vaccine scandal (Reuters)
  • Mahmoud Fikri appointed as Regional Director for the WHO Eastern Mediterranean Region (WHO)

US: Pharmaceuticals & Biotechnology

  • Machine Vision Helps Spot New Drug Treatments (MIT Technology Review)
  • Find and Replace: DNA Editing Tool Shows Gene Therapy Promise (NIH)
  • The Hollywood Analogy (In The Pipeline)
  • Cellectis aims for safer CAR T construct (BioCentury)
  • Banned from Twitter, Martin Shkreli whips up a new online tirade in response to a mocking dig from PhRMA chief (Endpoints)
  • GSK US Pharma President Jack Bailey On A "Dynamic" 2017 (SCRIP-$)
  • Researchers credit Obamacare with helping find early-stage cancer (Reuters)
  • FDA 2017 List of 101 Guidances - How Many Apply to Compounding Pharmacies and Are You Current and in Compliance??? (Lachman Consultants)
  • Hopes in the machine (BioCentury)

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

  • Abeona says it will start Sanfilippo B gene therapy trial in Q2 (Fierce)
  • Perrigo Announces FDA Approval Of Its First-To-File AB Rated Generic Version Of Topicort® Spray, 0.25% (Press)
  • FDA Accepts BeyondSpring IND Application for Plinabulin for the Prevention of Chemotherapy-Induced Neutropenia (Press)
  • CeloNova BioSciences Announces Clinical Results from Pivotal PzF SHIELD Clinical Trial Published in the Journal of the American College of Cardiology: Cardiovascular Interventions (Press)
  • Arsanis Announces First Patient Dosed in Global Phase 2 Study of ASN100 for Prevention of Staphylococcus Aureus Pneumonia (Press)
  • Flex Pharma Focuses on Phase 2 Clinical Programs in Severe Neurological Diseases (Press)
  • Landmark First-In-Human Clinical Study Launch Using a Genetically Engineered Natural Killer Cell for the Treatment of Cancer (Press)

US: Medical Devices

  • Report: IRS agrees to slash Medtronic's $1.4B transfer pricing tax tab by an order of magnitude (MassDevice)
  • Edwards Lifesciences closes $690m Valtech Cardio buy (MassDevice)
  • Johnson & Johnson mulls 'strategic options' for diabetes business (MassDevice)
  • Abbott touts study showing SCS helps curb opioid use in chronic pain patients (MassDevice)
  • BD wins expanded FDA 510(k) clearance for PleurX cath system (MassDevice)
  • 7D Surgical wins FDA, Health Canada nod for spinal surgical guidance system (MassDevice)
  • Medtronic launches trial for Visualase MRI-Guided laser ablation device in epilepsy patients (MassDevice)
  • Prescient Surgical Wins FDA De Novo Clearance for CleanCision System (Press)
  • FDA Approves FUJIFILM's Digital Breast Tomosynthesis Option for ASPIRE Cristalle Digital Mammography System (Press)

US: Assorted & Government

  • Federal Judge Blocks Aetna-Humana Merger on Antitrust Grounds (WSJ) (Reuters)
  • Slavitt: Mylan Owes Medicaid Rebates For Misclassifying EpiPen (Inside Health Policy-$)
  • FDA's Savings Machine: The White Oak Conference Room (Pink Sheet-$)
  • You Can Hide But You Can't Run (Drug & Device Law)
  • First Amendment Considerations Addressed (and Rejected) in FDA Memorandum (FDA Law Blog)
  • Why the C.D.C.'s Power to Quarantine Should Worry Us (NYtimes)
  • Trump reverses abortion-related U.S. policy, bans funding to international health groups (Washington Post)

Upcoming Meetings & Events


  • Amatsigroup buys French Pyrofree manufacturing specialist Disposable-Lab (OutsourcingPharma)
  • Breast implant victims win payout from German safety body (EurActiv)
  • Innovation and the EU: Fewer apps, more vaccines (EurActiv)
  • MPs condemn "arbitrary" decisions on infertility treatment (BMJ)
  • First company gains GMP approval in producing medicinal cannabis (PharmaLetter-$)
  • Medtronic Announces CE Mark for New Lower Profile HawkOne 6F Directional Atherectomy System (Press) (MassDevice)
  • Amoxicilline / Acide Clavulanique Sandoz - Rupture de Stock / Tensions d'Approvisionnement (ANSM)
  • ABPI Wales responds to Welsh Government Written Statement: The Independent Review of the Individual Patient Funding Request (IPFR) Process (ABPI)
  • ABPI responds to the launch of the government consultation on Industrial Strategy (ABPI)


  • Pharma industry wants budget to offer tax clarity (Economic Times)
  • Healthcare & medical device sectors press for zero import duty in Budget 2017 to spur Make in India programme (PharmaBiz)
  • Ajanta Pharma denies alert from USFDA, says supply is on (Economic Times)


  • Medical Devices Safety Update, Volume 5, Number 1, January 2017 (TGA)


  • Scientific Advisory Panel on Anti-Infective Therapies (SAP-AIT) (Health Canada)
  • Health Canada issues safety warning on fluoroquinolone antibiotics (PharmaLetter-$)

General Health & Other Interesting Articles

  • 'You never said my peer review was confidential' — scientist challenges publisher (Nature)
  • 8 people infected in rare U.S. outbreak of rat virus (CBS)

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

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

Categories: Recon, Regulatory News

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