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Regulatory Recon: Pfizer to Begin Shipping Remicade Biosimilar Next Month at 15% Discount Scandal in Italy Prompts Call for EU Pricing Probe (18 October 2016)

Posted 18 October 2016 | By Michael Mezher 

Regulatory Recon: Pfizer to Begin Shipping Remicade Biosimilar Next Month at 15% Discount Scandal in Italy Prompts Call for EU Pricing Probe (18 October 2016)

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

In Focus: US

  • Pfizer to start shipping biosimilar version of J&J's Remicade in November (Reuters) (WSJ)
  • Omnicare to pay $28 million to settle charges it got kickbacks from Abbott Labs (Reuters) (DoJ)
  • FDA staff flag concerns about Allergan's urinary drug (Reuters)
  • St. Jude Medical Forms Cybersecurity Advisory Group (WSJ) (MassDevice)
  • New FDA/EMA rare diseases and patient engagement clusters underway (FDA Voice)
  • AstraZeneca's hyperkalemia drug resubmission accepted by FDA (PharmaLetter-$) (Press)
  • CBER Strategic Plan 2017-2019: Increase Threat Preparedness, Improve International Collaborations (Focus)
  • FDA Helps Fund 21 Early Phase Trials For Rare Disease Treatments (Focus)
  • GDUFA II Performance Goals: 8-Month Priority Reviews, More Timely Correspondence (Focus)
  • Efficiency Bows To Scrutiny: '90s Drug Development Timelines Have Doubled (SCRIP-$)
  • White House report outlines push to bolster cancer research (Reuters) (WSJ) (Politico) (Forbes) (AdvaMed)
  • The Best—and Worst—Things About Joe Biden's Cancer Moonshot (MIT Technology Review)
  • #CuresNow: Ready for Liftoff (Energy & Commerce)
  • Reliable Next-Gen Data May Avert FDA Review, Shuren Says (Bloomberg)
  • A Phoenix Rising from The Ashes: FDA Proposes a Rule Requiring Submission of Device Labels and Package Inserts (FDA Law Blog)

In Focus: International

  • The MDR – where are we now? (MedicalDevicesLegal)
  • Medical Technology Sales To Hit $500B Within Five Years (Forbes) (MassDevice) (EP Vantage)
  • Italian pharma scandals prompts call for EU-wide pricing probe (PMLive)
  • Japan seeks hefty cut to blockbuster Opdivo price as officials pull back the reins on health spending (Fierce)
  • Asia Regulatory Roundup: CFDA Releases Draft Guidance on Data Management (Focus)
  • China Food And Drug Administration Issues New Requirements For Clinical Trial Applications And New Drug Applications (Focus)
  • Dutch Report Finds Silimed Breast Implants Carry Little Risk To Patients (Focus)
  • Boston Scientific details Malaysia expansion plans (MassDevice)
  • Promoting biological standardisation – NIBSC and NIFDS sign MoU (MHRA)
  • Bayer's Euphoria Around New Cancer Medicine Meets Skepticism (Bloomberg)
  • Big Pharma's India shadow (LiveMint)
  • UN High Level Panel report is good prescription for change in access to medicines (PharmaLetter-$)
  • Roadmap On Improvements To EMA's Literature Monitoring Service Due By Year End (Pink Sheet-$)

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US: Pharmaceuticals & Biotechnology

  • FDA Generic Drug Review Dashboard (FDA)
  • Blog: Does the FDA enable drugmakers to jack up prices on cheap old drugs? (Modern Healthcare)
  • Armed antibody player ADC lands a $105M mega-round to back pipeline construction (Endpoints)
  • Nancy Stagliano bags another $45M for True North's rare disease R&D (Endpoints)
  • Huge Spread in Patient Copays for HCV Drugs (Medpage)
  • Depomed to Add Starboard Nominees, Ending Dispute Over Board (WSJ)
  • Next-generation multiple myeloma treatment: a pharmacoeconomic perspective (Blood Journal)
  • Guest Post -- Recent Software Case Gives Important Lessons for Biotech (Patent Docs)
  • Clinical trials enter the genomic age (PMLive)
  • Lupus and pregnancy: New treatments steer clear of birth defects (Washington Post)
  • G-CON Manufacturing expands cleanroom POD production capacity in US (Manufacturing Chemist)
  • An FDA oncology analysis of immune activating products and first-in-human dose selection. (Regulatory Toxicology and Pharmacology)
  • Is the Interval Between Drug Inspections and Warning Letters Decreasing? (Unger Consulting)
  • Thermo Fisher: pharmacogenomics tool to make clinical trials more efficient (OutsourcingPharma)
  • What Effect Does ICH E6 R2 Have on Risk-Based Monitoring and Overall Quality Risk Management? (Bioclinica)
  • FDA Expert Scott Lassman Joins Goodwin's Life Sciences Practice as Partner in Washington, D.C. (Press)
  • NIH scientists uncover genetic explanation for frustrating syndrome (NIH)
  • New Approach to Promoting HPV Vaccinations (WSJ)
  • ​Pancreatic cancer drug developed in the Bay State approved in Europe (Boston Biz Journal)
  • GSK backs controversial flu tracker in Theraflu launch deal with Weather Channel (Fierce)
  • New formulation of ibuprofen may be superior for pain relief than the current version (MNT)
  • Lilly Partners with the National Cancer Institute to Accelerate Cancer Research through New Program under Cancer Moonshot Initiative (Press)
  • Bristol-Myers Squibb Foundation Joins White House Cancer Moonshot (BMS)
  • FMD K&L Merged with iMEDGlobal (Press)
  • Notice of Opportunity for Hearing Issued for Two Methylphenidate Generics to Concerta (Lachman Consulting)

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

  • Long-Term Efficacy Data Added to Binge Eating Disorder Drug Labeling (MPR)
  • Long-Term Safety Data for Novel Chronic Idiopathic Constipation Drug Announced (MPR)
  • Celgene's big hope ozanimod lowers pMS score in long-term ulcerative colitis (Fierce)
  • Gynesonics Announces Early Completion of Enrollment in the SONATA FDA Clincial Trial for Incision Free Treatment of Symptomatic Uterine Fibroids (Press)
  • First Patient Randomized in Multiple Dose Cohort of Phase 1/1b Trial with Transgene's TG1050 in Chronic Hepatitis B Patients (Press)

US: Medical Devices

  • Medical Technology Start-Ups In Free Fall As Industry 'Grays' (Forbes)
  • IBM and Quest forge precision cancer treatment partnership (Pharmafile)
  • Device Quality as a Marketing Tool (MDDI)
  • ISO 17025 Accreditation—What You Need to Know (MDDI)
  • Johnson & Johnson's Q3 numbers top estimates, medical devices biz grows slightly (MassDevice)
  • Class 1 Device Recall HVAD (FDA)
  • FDA Approves AI-Powered Automated Plate Assessment System (MedGadget)
  • Aerogen touts study of Solo vibrating mesh for aerosol drug delivery (MassDevice)
  • Veritas Genetics Lands $30M for $1,000 Genome Sequencing (Xconomy)
  • Merz Aesthetics Announces Three Year FDA Clearance for Cellfina™ System (Press)

US: Assorted & Government

  • Mylan Sued By EpiPen Buyers Over Pricing, Marketing Tactics (Law360-$)
  • Pruning REGROW (BioCentury)
  • Employer Pharmacy Benefits in 2016: More Specialty Drug Cost-Shifting Means More Problems for Patients (DrugChannels)
  • 7 Insurers Alleged To Use Skimpy Drug Coverage To Discourage HIV Patients (KHN)
  • How Trump, Clinton would fix the 'crazy' U.S. health system (Reuters)
  • Sanders rallies for California drug pricing crackdown that pharma's eager to defeat (Fierce)
  • MACRA: Did CMS bend the rule too much? (Politico)
  • MEDICARE: CMS's Round 2 Durable Medical Equipment and National Mail-order Diabetes Testing Supplies Competitive Bidding Programs (GAO)
  • No consistent gains in quality of U.S. outpatient care (Reuters)

Upcoming Meetings & Events


  • Nor-Switch Study: Another Significant Example Of Positive Real World Evidence On Physician-Led Switching To Biosimilar Medicines (Medicines for Europe)
  • UK drug discovery landscape in fundamental shift towards collaboration and open innovation (ABPI)
  • Teva to launch production of Copaxone in Russia (PharmaLetter-$)
  • Merck expands biotech production capacity in Spain (PharmaLetter-$)
  • MHRA Updates Official PIM Designation Statistics, EAMS Scientific Opinions (MHRA 1, 2)


  • China's TOT Biopharm starts stage II construction for commercial production of MAb drugs (PharmaLetter-$)


  • Health ministry considering to amend D&C Act to implement track & trace system for domestic products (PharmaBiz)
  • Cooperation of pharma cos & law enforcement agencies key to tackle counterfeit drug menace: PSI (PharmaBiz)
  • Government targets 500 combination drugs, confrontation with pharma companies looming (Economic Times)


  • Quark Venture, with help from China, sets up $500M life sciences fund in Canada (Fierce)


  • Hazard Alert - St Jude ICDs and CRT-Ds - various models (TGA)
  • Aussie firm cuts 'off-air' time for cochlear implant recipients (MedCityNews)


  • Singapore 'closes' Zika zone as virus spread dwindles (Reuters)
  • Amid government silence, Venezuela's microcephaly babies struggle (Reuters)

Other International

  • Opening remarks at the Tokyo ICD-11 revision conference (WHO)
  • WHO adds gatifloxacin to prequalification list to encourage API manufacturers (In-PharmaTechnologist)
  • Cuba: A Pharmaceutical Regulatory Snapshot (Pink Sheet-$)

General Health & Other Interesting Articles

  • Caffeine Study Gives Heart Failure Patients Green Light To Drink Coffee (CardioBrief)
  • Why do autoimmune diseases affect women more often than men? (Washington Post)
  • The Culture Of Health Action Framework And Systems Science: Opportunities And Challenges (Health Affairs Blog)
  • How We Smell Those Delightful Little Sulfur Compounds (In the Pipeline)
  • World's first three-parent IVF baby birth 'revolutionary': doctor (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

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

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