Regulatory Recon: Two Possible Trump Picks for FDA Commissioner Will Congress Ax Recent FDA Rules in the Next Administration? (8 December 2016)

Posted 08 December 2016 | By Michael Mezher 

Regulatory Recon: Two Possible Trump Picks for FDA Commissioner Will Congress Ax Recent FDA Rules in the Next Administration? (8 December 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

In Focus: US

  • Senate Overwhelmingly Passes 21st Century Cures Act Despite Patient Safety Concerns (Focus) (KHN) (WSJ) (Medpage) (NYTimes) (Reuters)
  • Biden's farewell gift: Cancer moonshot helps pass $6.3 billion research bill (Politico)
  • Trump vows to bring down drug prices, doesn't say how (Reuters) (Pink Sheet-$)
  • Cassidy Says Obamacare Repeal Will Not Repeal Biosimilars Approval Pathway (Focus)
  • FDA Says Real-World Evidence Could Generate 'Incorrect or Unreliable Conclusions' (Focus)
  • Will Any of FDA's Recent Rules Wind Up On the Congressional Chopping Block? (FDA Law Blog)
  • Trump Presidency Could Offer New Challenges for Shaky Drug Sector (The Street) (Xconomy)
  • Slavitt: 'There should be no pride of authorship' with healthcare reform (Modern Healthcare)
  • Five Reasons The ACA Won't Be Repealed (Health Affairs Blog)
  • Inside HHS: Staff worry, grieve as Trump era looms (Politico)
  • Two candidates on Trump short list for FDA commissioner (BioCentury)
  • Horizon Pharma drug fails key study in rare neuromuscular disease (Reuters)
  • Expected U. Cal. Victory in Gene Editing Dispute in Question (Bloomberg)
  • Drugmakers Want Tough Scrutiny of 340B Discount Program (Bloomberg)
  • FNIH releases final biomarker framework (BioCentury)
  • 1 Patient, 7 Tumors and 100 Billion Cells Equal 1 Striking Recovery (NYTimes) (NIH)
  • Personalized Cancer Vaccine Prevents Leukemia Relapse in Patients (MIT Technology Review)
  • FDA Makes Hearing Aids More Accessible (Focus)
  • The Rising Price of Naloxone — Risks to Efforts to Stem Overdose Deaths (NEJM)
  • Gilead's CEO Apologetic About Sovaldi's $1,000 Per Pill Price Tag (Forbes)
  • Genetically Engineered Mosquitoes Waved Through Here, Swatted Down There (GEN)
  • MIT team reduces beta amyloid plaques in mice with light therapy (BioWorld)
  • Parkinson's gene therapy data sparks Voyager stock jump (Fierce)
  • Health Coalition Worries Trump Doesn't Grasp Value-Based Care (Forbes)
  • Abbott files to terminate $6B Alere acquisition (MassDevice) (Law360-$)
  • Pharma sector offers rich pickings for management consultants (Financial Times)
  • FDA Publishes Updated Patent Information Forms (FDA Lawyers Blog)

In Focus: International

  • Sweden joins dash to host EU drugs agency instead of London after Brexit (Reuters)
  • End of life care must be for the whole family not just the dying child, says NICE in new guidance (NICE)
  • A Candid Behind-The-Scenes Look At PRIME with Novimmune & Biogen (Pink Sheet-$)
  • JHL and Sanofi plan to sell biosimilars outside China (BioPharmaReporter)
  • Interpreting Geographic Variations in Results of Randomized, Controlled Trials (NEJM)
  • Indian pharma industry facing growth headwinds: ICRA (Economic Times)
  • EU regulator accepts Sanofi/Regeneron's Dupixent product for review (Reuters) (Fierce)
  • Teva embroiled in internal bribery investigation (Pharmafile)
  • European thumbs up for Abbvie leukaemia drug (Pharmafile)
  • Neovasc soars as mitral valves head to Europe (EP Vantage)
  • GSK India "Women's Board" Sets Out To Close Gender Gap (SCRIP-$)
  • UN, international health and development agencies to promote environmentally and socially responsible procurement of health commodities (WHO)

US: Pharmaceuticals & Biotechnology

  • FDA's Tough Stance On Patient-Reported Outcomes Underscored At Repros Meeting (Pink Sheet-$)
  • Hitting The Milestones: Update On Earning "Biobucks"(LifeSciVC)
  • Pros and Cons of Biosimilars (PharmaceuticalManufacturing)
  • Patients' Right-To-Try Should Not Be A License To Fleece Them (Forbes)
  • Out of Ideas? (In The Pipeline)
  • World Lung – Companies look to fill brain metastasis niche (EP Vantage)
  • Nitration Isn't So Simple (In The Pipeline)
  • Kendall Square's boarding school for biotechs (MedCityNews)
  • Sanofi and Merck & Co team with Natrix on 'truly disposable' Protein A platform (BioPharmaReporter)
  • Boehringer Ingelheim Vetmedica, Inc. and Bayer Enter Into Agreement for Purchase of U.S. Cydectin® Product Portfolio (Press)
  • Most people want to learn about their skin biopsy results online (Reuters)
  • UCSF, GE Partner to Advance Artificial Intelligence in Radiology (Medpage)
  • CRISPR/Cas9 transforming research, says Charles River CSO (OutsourcingPharma)
  • Screening for Babesia microti in the U.S. Blood Supply (NEJM) (Reuters)
  • CDC Extends Comment Period on Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compound Administration of Hazardous Drugs (CDC)

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

  • Novartis' Zykadia ASCEND-4 Study Close But No Cigar In NSCLC (SCRIP-$)
  • Puma Biotechnology Presents Interim Results of Phase II CONTROL Trial of PB272 in Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer at the 2016 San Antonio Breast Cancer Symposium (Press)
  • Puma Biotechnology Presents Interim Results of Phase II Trial of PB272 for ERBB2 (HER2) Mutant, HER2 Non-Amplified, Metastatic Breast Cancer at the 2016 San Antonio Breast Cancer Symposium (Press)
  • Puma Biotechnology Presents Results of Biomarker Analysis of Phase II Trial of PB272 in Neoadjuvant Treatment of HER2-Positive Locally Advanced Breast Cancer at the 2016 San Antonio Breast Cancer Symposium (Press)
  • GTx Reports Results from Ongoing Enobosarm Phase 2 Clinical Trial in ER+/AR+ Breast Cancer (Press)
  • Transgene: UC Davis to Conduct Phase 2 Trial of the Combination of TG4010 with Opdivo® (nivolumab) for 2nd Line Treatment of Metastatic Non-Small Cell Lung Cancer (NSCLC) (Press)

US: Medical Devices

  • The One-Billion-Dollar Verdict (Drug and Device Law)
  • FDA adds high-risk indication to Abiomed's Impella CP heart pump (MassDevice)
  • FDA releases November 2016 510(k) clearances (MassDevice)
  • FDA releases October 2016 510(k) clearances (MassDevice)
  • Terumo moves forward on $1B deal to pick up St. Jude, Abbott vascular assets (MassDevice)
  • Baxter releases infusion pump programming software (MassDevice)
  • Baxter lays off 12 at Bloomington facilities (MassDevice)
  • Exact Imaging Receives FDA 510(k) Clearance for Its ExactVu™ Micro-Ultrasound System (Press)

US: Assorted & Government

  • PTAB Life Sciences Report -- Part I (Patent Docs)
  • Plan Sponsors Like More Transparent PBMs—Yet Not All Choose Transparency (Drug Channels)
  • Drug Price Transparency Before California Lawmakers Again (California Healthline)
  • Supreme Court Hears Oral Arguments in Life Technologies, Promega Infringement Case (GenomeWeb)
  • The FTC's Overreaching Regulation Of Homeopathic Drugs (Law360-$)

Upcoming Meetings & Events


  • Adaptive pathways workshop (Video)
  • Meeting Minutes - Meeting of the Competent Authorities for Tissues and Cells (EC)


  • Hanmi falls after J&J halts enrollment in diabetes trial (BioCentury)



  • Consultation: National Health Genomics Policy Framework: Conducted by the Department of Health (TGA)


General Health & Other Interesting Articles

  • Life Expectancy In U.S. Drops For First Time In Decades, Report Finds (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

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

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