Regulatory Focus™ > News Articles > Regulatory Recon: Legal Experts Question Alternative 510(k) Pathway; France Fines J&J Over Painkille

Regulatory Recon: Legal Experts Question Alternative 510(k) Pathway France Fines J&J Over Painkiller Patch (20 December 2017)

Posted 20 December 2017 | By Michael Mezher 

Regulatory Recon: Legal Experts Question Alternative 510(k) Pathway France Fines J&J Over Painkiller Patch (20 December 2017)

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

In Focus: US

  • Best of 2017: What Readers Clicked on This Year (Focus)
  • GOP Finally Notches 2017 Victory While Bracing for 2018 Verdict (NYTimes 1,2) (Washington Post) (Senate Finance)
  • House to vote again on tax bill; Trump on verge of win (Reuters)
  • FDA Medical Device Proposal May Skirt the Law: Legal Experts (Reuters)
  • NY AG Announces $13.5M Multi-State Settlement With Boehringer Ingelheim for Deceptive Marketing Practices and Promotion of Prescription Drugs for Unapproved Uses (NY AG)
  • Samsung Bioepis says FDA to review Herceptin copy (Reuters)
  • The Loopholes Drug Companies Use to Keep Prices High (Bloomberg)
  • Pfizer, Exelixis cancer drugs get FDA approval for wider use (Reuters) (Fierce) (Press) (Press)
  • Pfizer Shareholders Are Already Enjoying the Fruits of Tax Cuts (Bloomberg) (Fierce)
  • ICER Issues Draft Report on Value CAR-T Therapy (ICER)
  • The FDA wants more medical devices in your pocket (Marketplace)
  • A Contraceptive Gel for Men Is About to Go on Trial (MIT Technology Review)
  • Lawmakers demand answers on a huge price hike for an old drug (STAT) (Endpoints)
  • FDA Approves New Gene Therapy Targeting Specific Mutation (Focus) (Endpoints) (Forbes)
  • Another death mars AbbVie's latest batch of promising data for its star rheumatoid arthritis drug (Endpoints) (Fierce)
  • Sandoz Gets Early Win In Amgen IP Dispute Over Neulasta (Law360-$)
  • PTAB Decides Patent Infringement Lawsuit Waives 11th Amendment Sovereign Immunity to Inter Partes Review (Patent Docs)

In Focus: International

  • France fines J&J 25 million euros over painkiller patch (Reuters)
  • Gene therapy developer Orchard Therapeutics raises $110 million (Reuters) (Endpoints) (Fierce)
  • Teva rejects Israeli PM's request to keep Jerusalem plant open (CNBC)
  • Experts call for use of Sanofi's dengue vaccine to be halted in most cases (STAT)
  • Japan to Shave 720 Billion Yen through FY2018 Drug Price Revision (PharmaJapan)
  • EU Clinical trial transparency reaches record level (EPR) (ABPI)
  • GSK forced to pay back £1.5m to Scottish Government after recent job cuts (Pharmafile)
  • Sanofi, Alnylam file hATTR amyloidosis therapy in the EU (PharmaTimes)
  • 'Drugs are too expensive for the NHS – and people are paying with their lives' (The Guardian)
  • NICE recommends Novartis' Extavia for MS, but knocks back a raft of other beta interferons (Pharmafile) (NICE)
  • Takeda's Ninlaro approved for NHS use via CDF (PharmaTimes)
  • NICE turns down rare skin disease implant (PharmaTimes)
  • Roche pens neurological, developmental disorder drug discovery pact with Confo (Fierce)
  • Asia Regulatory Roundup: TGA Resists Industry Pressure to Change Adverse Event Reporting Timelines (Focus)
  • EU Indication Extensions On Cards For Taltz, Truvada and Yervoy (Pink Sheet-$)
  • Singapore's Tessa raises $80M for T cell therapy push (Fierce)
  • India developing bulk drugs to reduce import dependence (Economic Times)
  • Strides bags majority stake in South Africa's Trinity (Economic Times)

Pharmaceuticals & Biotechnology

  • You Spoke, FDA Listened: New Patient Engagement Collaborative, Call for Nominations (FDA) (Federal Register)
  • Public Workshop on Patient-Focused Drug Development: Guidance 1 – Collecting Comprehensive and Representative Input (FDA)
  • Can a multibillion-dollar biotech prove its RNA drugs are safe for a rare disease? (Science)
  • FDA warns about MRI contrast agents, while UK takes tougher stance (STAT) (Medpage) (FDA) (MHRA)
  • NIH study uncovers clues about why common cancer drug causes hearing loss (NIH)
  • After axing a top drug, Millendo bags a PhII replacement with biotech buyout (Endpoints)
  • Flagship adds $618M in new funds to fuel startup mission (Endpoints)
  • With AveXis coming up in the rear view mirror, Biogen and Ionis go back to the drawing board on SMA (Endpoints)
  • FDA Doesn't Support Creating Ultra-Orphan Designation (Pink Sheet-$)
  • Problems Continue To Plague Tumor Biomarker Tests (Medpage)
  • Biotech's sweet home: Alabama? (MedCityNews)
  • Shifting forecasts reveal the winners and losers of 2017 (EP Vantage)
  • Spectrum Pharma Fires CEO, Shuffles Executive Lineup (Biospace)
  • If you liked pharma's innovation challenges in 2017, just wait. More are coming (Fierce)
  • New ways to trigger—and tailor—messages may get pharma's info past the physician filter (Fierce)
  • Ask and get health answers: Will 2018 be a tipping point for pharma voice assistants? (Fierce)
  • Having An Egg Allergy Is No Longer An Excuse To Skip Getting A Flu Shot (Forbes)
  • What You Need To Know About Clinical Trials (Before You Need One) (Forbes)
  • Top CRO and CMO M&A activity of 2017 (Outsourcing Pharma)
  • Regulatory roundup: Reviewing global changes in 2017 (Outsourcing Pharma)
  • Do sponsors no longer believe recruitment estimates? The CRO 'dilemma' (Outsourcing Pharma)
  • Merck and ViiV are keeping it real with their TV ads. Which drugmakers will follow? (Fierce)
  • TARIS and Bristol-Myers Squibb Announce Clinical Trial Collaboration (Press)
  • Cellectis interview – if at first you don't succeed... (EP Vantage)
  • 3M aims at double-digit growth in $5.5bn biopharma filtration market (BioPharmaReporter)
  • Appointments: IFPMA, German Merck, Ergomed, Spectrum, Astellas, Laboratoris Sanifit and Audentes Therapeutics (SCRIP-$)
  • Parker Institute-allied Tessa grabs an $80M round for its next-gen cancer cell therapies (Endpoints)
  • FDA Publishes Draft Guidance on Drug Products, Including Biological Products, That Contain Nanomaterials (National Law Review)
  • AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Pantoprazole Sodium for Injection 40 Mg Per Vial, Due to Presence of Glass Particles in the Vial. (FDA)
  • Important Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding Zika Virus Transmission in Hidalgo County, Texas (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Loxo starts rolling NDA for cancer drug larotrectinib (Fierce) (Press)
  • TherapeuticsMD Announces FDA Acceptance of New Drug Application and Prescription Drug User Fee Act (PDUFA) Date for TX-004HR (Press)
  • JAMA Publishes Final Analysis of EF-14 Phase 3 Pivotal Trial of Optune Together with Temozolomide Demonstrating Unprecedented Survival Results for Newly Diagnosed Glioblastoma (Press)
  • Peloton Therapeutics Phase 1 Study of PT2385 Published in the Journal of Clinical Oncology Validates HIF-2α Antagonism for the Treatment of Kidney Cancer (Press)
  • Arrowhead Pharmaceuticals Files for Regulatory Clearance to Begin Phase 1 Study of ARO-AAT (Press)
  • MabVax Therapeutics Announces Completion of Enrollment and Initial Patient Dosing in an Expanded Cohort of the Phase 1 Trial Evaluating MVT-5873 in Combination with First-Line Chemotherapy (Press)
  • Green Cross Wellbeing Announces BfArM Authorisation to Initiate Phase 2 Study of BST204 for Cancer Cachexia (Press)

Medical Devices

  • New Report Outlines Gaps in Payment Model Quality Measures (AdvaMed) (White Paper)
  • Zimmer Biomet Hires Medtronic Exec Bryan Hanson for CEO Role (Xconomy)
  • PerkinElmer closes $1.3B Euroimmun buy (Drug Delivery)
  • Defibrillation Electrodes for Lifepak AEDs by Physio-Control: Class I Recall - Incorrect Placement Instructions for Infants Depicted on Artwork (FDA)
  • Bob White Named Executive Vice President and President of Medtronic's Minimally Invasive Therapies Group; Chris Lee to Assume Leadership of Medtronic's Asia Pacific Region (Press)
  • Glaukos wins FDA nod for IDE trial of iStent SA (MassDevice)
  • PENTAX Medical Announces Launch Of First FDA-Cleared HD Duodenoscope With Disposable Distal Cap (Endpoints)
  • Skyline Medical to take 20% stake in Helomics, license Illumina's gene sequencing tech (MassDevice)
  • Fuse Medical to acquire orthopedics distributor CPM Medical Consultants (MassDevice)
  • Prescient Surgical Receives FDA 510(k) Clearance for Its Novel CleanCision Wound Retraction and Protection System (Press)
  • Avinger wins CE Mark for next-gen Pantheris atherectomy device (MassDevice)

US: Assorted & Government

  • 'It's My Life': Brain Cancer Motivates City Commissioner's Activism (NYTimes)
  • A Seven-Word Mystery at the CDC (Bloomberg)
  • Ryan vs. McConnell on Obamacare (Politico)
  • Dozens of conservative groups oppose Alexander-Murray (Politico)
  • Emergency Disaster Aid Package Introduced  (House Appropriations)
  • USRM Responds to Lawsuit Filed for Discontinued Eye Treatments (Press)
  • Ninth Circuit Undoes Incretin Implied Preemption Ruling – For Now (Drug & Device Law)
  • 340B guidance from CMS further inflames worries over reimbursement cuts (Modern Healthcare-$)
  • House lawmakers to discuss 340B legislation this week as tensions build (Modern Healthcare)
  • Detroit, Macomb County sue drug companies over opioid epidemic: 'Enough is enough' (Detroit Free Press)
  • Nashville cleared to explore opioid lawsuit with contracting dispute now resolved (Tennessean)
  • Baltimore health commissioner says businesses can help with opioid epidemic (Baltimore Sun)
  • Flurry of Health-Care Deals Reflects Shift Away From Hospitals (WSJ)

Upcoming Meetings & Events


  • Draft qualification opinion on Proactive in chronic obstructive pulmonary disease (COPD) (EMA)
  • Guidance for applicants requesting scientific advice (Veterinary) (EMA)
  • Pharma serialization snapshot: Russia (Securing Industry)
  • Russian government aims to increase drug exports in coming years (PharmaLetter-$)


  • How GSK Is Experimenting With Seretide-28 In India (SCRIP-$)
  • Morepen Labs gets USFDA nod for asthma drug (Economic Times)
  • Rohit Sathe to head Philips India Healthcare (Economic Times)
  • Natco launches tenofovir alafenamide 25 mg for treating hepatitis B (PharmaBiz)
  • Maha FDA cancels 36 mfg licenses, suspends 90 licenses across state for non- compliance (PharmaBiz)


  • PIC/S & EMA consultation: Revision of Annex 1 Manufacture of Sterile Medicinal Products (TGA)
  • Use of international assessments (TGA)
  • Regulator Performance Framework: Self-assessment Report, July 2016 to June 2017 (TGA)
  • Presentation: Therapeutic Innovation Australia Symposium 2017, 14 December 2017 (TGA)

General Health

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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.