Regulatory Recon: Trump Promises 'Insurance for Everybody' FDA Extends Review of Lilly Rheumatoid Arthritis Drug (16 January 2017)

Posted 16 January 2017 | By Michael Mezher 

Regulatory Recon: Trump Promises 'Insurance for Everybody' FDA Extends Review of Lilly Rheumatoid Arthritis Drug (16 January 2017)

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

In Focus: US

  • Trump Promises 'Insurance for Everybody' as Health Law Replacement (NYTimes) (Reuters) (Washington Post)
  • House Clears Path for Repeal of Health Law (NYTimes) (Inside Health Policy)
  • After talking to Trump about top FDA job, Balaji Srinivasan erased his barbed criticism of the drug agency (Endpoints)
  • Surprising contenders emerge for Trump's NIH chief (Nature) (Fierce)
  • US Supreme Court to Review Biosimilar 'Patent Dance' (Focus) (Reuters) (Law360-$) (Big Molecule Watch) (Patent Docs)
  • FDA extends review time for Lillys' RA drug (PharmaLetter-$) (PharmaTimes) (Lilly)
  • The Heroism Of Incremental Care (The New Yorker)
  • The SCCHN drug market (Nature)
  • Gates Foundation research can't be published in top journals (Nature)
  • Australian Drug Maker Has Low Profile but Powerful Backers in Washington (NYTimes)
  • Bio-Rad to Acquire RainDance Technologies (GEN)
  • FDA Further Explains Delay on LDT Guidance (Focus) (FDA) (BioCentury) (ACLA Statement)
  • Analysis: Longer Review Times Associated With Fewer Adverse Events for High-Risk Heart Devices (Focus)
  • Human Factors Studies for Generic Combo Products: FDA Offers Draft Guidance (Focus)
  • FDA Draft Guidance Looks to Help Speed New Generics to Market (Focus)
  • Fujifilm pulls older duodenoscopes after superbug outbreaks (MassDevice) (FDA)
  • 2016 Year in Review: MDR Reporting Enforcement (Inside Medical Devices)
  • FDA Ban on Powdered Medical Gloves Applies to Veterinary Use (FDA)
  • Pricing pressure in US to keep pharma companies' growth under check (Economic Times)
  • Crystal-ball seer Avalere: Pricing frets not obsolete as new strategies probed (BioWorld)
  • Pa. painkiller prescriptions drop after creation of monitoring program (Washington Post)
  • The United States already has a vaccine safety commission. And it works really well, experts say. (Washington Post)

In Focus: International

  • Eyes of the world on case concerning best-ever-selling drug (PharmaLetter)
  • New approach needed to tackle rising drug prices (OECD)
  • Statement from EFPIA President Joe Jimenez on the upcoming OECD Health Ministerial (EFPIA)
  • IQWiG finds no added benefit for Xalkori (PharmaLetter-$)
  • Two Important Decisions Addressing ANVISA's Prior Approval of Pharmaceutical Patents in Brazil (National Law Review)
  • India's Trial Approval Timelines Report Card – Some Red Lines? (Pink Sheet-$)
  • India Drug Watchdog Says 4-5% Of Drugs Still Substandard (Pink Sheet-$)
  • 2017 Not Looking As Bright As It Should Be For Turkish Pharma (SCRIP-$)
  • Sanofi licences ImmuNext autoimmune disease drug (PharmaTimes)
  • NPPA proposes to slash cardiac stent prices by 50% (Economic Times)

US: Pharmaceuticals & Biotechnology

  • Manufacturers Urged To Prevent Drug Shortages By Reducing Quality Risks (Pink Sheet-$)
  • 'Meaningless suffixes' slammed by industry in FDA naming guidance (BioPharmaReporter)
  • Price Rebates Will Continue As 'Fact Of Life' In Drug Contracting (Pink Sheet-$)
  • Benzodiazepines increase stroke risk in Alzheimer's patients, study finds (Pharmafile)

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

  • Trial to test fracture prevention combo in brittle bone patients (PharmaTimes)
  • FDA fast track status offers new hope for patient VivaGel investors (PharmaLetter-$)
  • Tocagen Expands Toca 5, Phase 2/3 Clinical Trial for Recurrent Brain Cancer, to South Korea (Press)
  • Chi-Med Presents Phase I/II Clinical Data for Selective VEGFR Inhibitor Fruquintinib at the 2017 Gastrointestinal Cancers Symposium (Press)

US: Medical Devices

  • Five Ways for Device Companies to Compete with Small and Low-Cost Players (MDDI)
  • FDA device guidance: Start with NIST cyber framework (Fierce)
  • The Robot That Performed My Kidney Transplant Declined to Be Interviewed (NYTimes)
  • Class 1 Device Recall The NucliSENS easyMAG Magnetic Silica (FDA 1, 2)
  • Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action - Immediately Remove and Reinstall Battery (FDA)
  • Abbott launches St. Jude Medical's Ensite Precision cardiac mapping (MassDevice)
  • Obalon logs 1st commercial use of weight loss balloon (MassDevice)

US: Assorted & Government

  • Medicare Secondary Payer – A Lot Less Boring Now (Drug & Device Law)             
  • Stronger malpractice laws may not prevent surgical complications (Reuters)
  • Insurance Customers In Pennsylvania Look To Trump To Ease Their Burden (KHN)

Upcoming Meetings & Events


  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 January 2017 (EMA)
  • Commission grants one more week to submit comments on strengthening EU cooperation on Health Technology Assessment! (EC)


  • China confirms one more human death from H7N9 bird flu (Reuters)
  • Transfer Of Rights To Insomnia Treatment / Anaesthesia Induction Agent Flunitrazepam In Japan (Press)


  • CDSCO Statement on Traveler's Death from Drug Resistant Bacteria (CDSCO)
  • Maha FDA forms special team to investigate anti-anxiety, narcotics drug haul case (PharmaBiz)
  • DoP finds NPPA's notification No.644(E) dated 2.3.2016 wrong in asking companies to further lower MRP than ceiling price fixed by NPPA (PharmaBiz)
  • Maha FDA cancels licenses of 2 wholesalers of Cipla for non-compliance of Drugs and Cosmetics Rules (PharmaBiz)
  • Haryana govt, AiMeD sign MoU to bring in Rs. 5,000 crore investment for Haryana medical devices industry (PharmaBiz)
  • Pharma exports from Gujarat grow exponentially (PharmaLetter-$)
  • Asia Pacific pharmacovigilance training course in Mysore, India (Uppsala Monitoring Centre)


  • Scheduling delegate's final decisions, January 2017 (TGA)


  • We must turn the tide on Canada's opioid crisis (Globe and Mail)
  • Health Canada approves Fujifilm's Vevo HD ultra-high-frequency ultrasound device (MassDevice)

Other International

  • Yellow Fever Outbreak in Brazil Prompts State of Emergency (NYTimes)

General Health & Other Interesting Articles

  • Psoriasis with arthritis linked to heart disease risk (Reuters)
  • Fruit Fly Alcohol Tolerance Investigated and Explained (GEN)

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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