Recon: EU Court Upholds €183M Fine Against Roche, Novartis; CHMP Rejects Puma's Breast Cancer Drug

Posted 24 January 2018 | By Michael Mezher 

Recon: EU Court Upholds €183M Fine Against Roche, Novartis; CHMP Rejects Puma's Breast Cancer Drug

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

In Focus: US

  • J&J takes $13.6 billion charge related to new US tax law (Reuters)
  • Reckoning the potential of CRISPR/Cas9 tech, NIH launches $190M genome editing research initiative (Endpoints) (NIH)
  • Pfizer: Rituxan Biosimilar Hits Primary Endpoint (Press) (Endpoints)
  • New York City sues drug companies over opioid epidemic (Reuters) (NYTimes) (The Guardian)
  • Drugmakers 'flush with cash' and hunting for deals (Financial Times)
  • CMS scraps plans to accelerate access to medical devices (Fierce) (Modern Healthcare)
  • Scientists Don't Fear a New CRISPR Snag (Bloomberg)
  • US appeals court upholds ruling invalidating J&J patent on Remicade (Reuters)
  • US lets more healthcare workers prescribe opioid addiction treatment (Reuters)
  • Where's The Tylenol? J&J Disappoints And Frustrates (Forbes)
  • The drug industry's two big trade groups set a new record for lobbying in 2017 (STAT)
  • NIH begins large HIV treatment study in pregnant women (NIH)
  • Apple, in Sign of Health Ambitions, Adds Medical Records Feature for iPhone (NYTimes)

In Focus: International

  • Puma Biotech finds European regulators inhospitable to breast cancer drug approval (STAT) (Endpoints) (Reuters)
  • 'Growing problem' of addiction to prescription drugs probed (BBC) (PharmaTimes)
  • New Index Rates Drug Companies in Fight Against 'Superbugs' (NYTimes) (Financial Times)
  • Roche and Novartis lose a key battle over antitrust fines in Italy (STAT) (Law360-$)
  • Nigeria set to vaccinate 25 million people, its biggest yellow fever campaign ever (WHO)
  • Novartis says Entresto could become $5 billion a year blockbuster drug (Reuters) (Financial Times) (Endpoints)
  • Novartis 2017 sales, profits beat estimates (Financial Times)
  • Drug price regulator seeks new category for high-end stents (Live Mint)
  • Japan's 1st Herceptin Biosimilar Likely to Be OK'ed by March for Gastric Cancer (PharmaJapanWeb)
  • Lilly's Taltz wins EU approval for psoriatic arthritis (PharmaTimes)
  • Mylan launches Copaxone generic in the UK (PharmaTimes)
  • Zambia says it is on verge of containing cholera outbreak (Reuters)
  • Gates backs Central America malaria elimination plan with $31 million (Reuters)
  • Pakistan Raises Its Guard After Two Polio Vaccinators Are Gunned Down (NPR)
  • Australia Says No To 'Complex' US-Style Suffixes For Biologicals (Pink Sheet-$)

Pharmaceuticals & Biotechnology

  • Transcript: State of CDER 2018 (FDA)
  • What's slowing biosim uptake? Pricing, contracting, clinical doubts and DTC ads (Fierce)
  • Cavazzoni Appointed CDER Deputy Director For Operations (BioCentury)
  • BMJ declares its revenues from industry (BMJ)
  • Chemicals, Shelves and Shelves of Them (In the Pipeline)
  • Column: Biosimilars offer savings, access (The Detroit News)
  • Wide inconsistency observed among clinical trials' startup time: Tufts report (Fierce)
  • Merck's Keytruda makes liver-cancer headway, putting BMS and Bayer on notice (Fierce)
  • When VCs hand out mega-rounds to Vir and Gossamer, are they betting on the jockey or the horse? (Endpoints)
  • Purdue is benefiting at the expense of vulnerable patients and taxpayers (The Hill)
  • Drug discounting to insurers soars from 28% to 41% in 5 years, with no end in sight: report (Fierce)
  • The new serial entrepreneur in the biotech arena launches another upstart looking to drug RNA (Endpoints) (Fierce)
  • UCB supports social network for SpA patients (PMLive)
  • Melinta: A Pure-Play Antibiotics Specialist Rises (SCRIP-$)
  • Health Care, Life Sciences M&A To Stay Strong In 2018 (Law360-$)
  • Paragon expansion to address 'deficit in gene therapy CDMO capacity' (BioPharmaReporter)
  • Tanisha Carino Joins Milken Institute's Fastercures (BioCentury)
  • Clinical trials, management software maker Bio-Optronics draws $30M investment (MobiHealthNews)
  • HEARING: #SubHealth to Conduct Check Up on Safeguards for Compounded Medications (House E&C)
  • In a Flurry of Activity, FDA Releases Compounding Final Guidances Addressing "Essentially Copies" of Commercially Available Drug Products for Both Section 503A and 503B Compounders (FDA Law Blog) (Lachman Consultants)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Cerus Reports Positive Top-Line Results from Chronic Anemia Phase 3 Study Evaluating INTERCEPT Red Blood Cells in Thalassemia Patients (Press)
  • Apexian Pharmaceuticals Opens Phase 1 Clinical Study of APX3330 in Patients with Solid Tumors (Press)
  • Bioatla Announces FDA Clearance Of Investigational New Drug Application For CAB-AXL-ADC Therapeutic (Press)

Medical Devices

  • Abbott shares up on Q4, 2017 earnings beat (MassDevice)
  • LivaNova closes $225m ImThera buyout (MassDevice)
  • IlluminOss Medical wins de novo nod from FDA for bone stabilization system (MassDevice)
  • Fearing regulatory backlash, Nokia proactively removes pulse wave velocity feature from Body Cardio scale (MobiHealthNews)
  • Cyberdyne's Medical Exoskeleton Strides to FDA Approval (IEEE)
  • 3 Medtech Markets That Are Showing Growth (MDDI)
  • FDA Office Of Pharmaceutical Quality Outlines Goals (BioCentury)
  • Shire Pledges To Exclusively Publish In Open-Access Journals (BioCentury)
  • Exclusive Interview with Dr. David Rhew, Chief Medical Officer of Samsung Electronics America (MedGadget)
  • Food, Drug, and Device Law Alert - FDA Proposes Defining "Significant Decision" in Safety and Innovation Act (National Law Review)
  • CMS Draft Coverage Policy on NGS Cancer Tests Raises Questions About Where Commercial Payors Stand (GenomeWeb)
  • Medtronic Launches ENCHANT Study to Evaluate ChEVAR Parallel Graft Technique with the Endurant(TM) II/IIs Stent Graft System (Press)
  • Medtronic launches Endurant II, IIs ChEVAR real-world study (MassDevice)
  • Centric Medical Announces FDA 510(k) Clearance of the Foot and Ankle Plating System (Press)

US: Assorted & Government

  • Wyden: Alex Azar is the Wrong Choice to Fix the Trump Administration's Disastrous Record on Health Care (Senate Finance)
  • Amid Shutdown Chaos, HHS Moves To The Right On Women's Health (TPM)
  • Pharma Can't Be Liable For Generics, GSK Tells 7th Circ. (Law360-$)
  • Patient Info Not A Kickback, MedImmune Says In Fraud Suit (Law360-$)
  • New Part D Data: CVS Wins Big in 2018's Preferred Pharmacy Networks (Drug Channels)
  • Guess what? Part B drug spending remains stable share of Medicare spending (PhRMA)
  • After Months In Limbo For Children's Health Insurance, Huge Relief Over Deal (NPR)
  • Vaping Can Be Addictive and May Lure Teenagers to Smoking, Science Panel Concludes (NYTimes)
  • Federal Health-Insurance Marketplace: Analysis of Plan Year 2015 Application, Enrollment, and Eligibility-Verification Process (GAO)
  • Zydus Gets FCA Claims Trimmed In Generics Pricing Row (Law360-$)

Upcoming Meetings & Events


  • Director at NICE leaves after 17 years (NICE)
  • NICE consults on updated recommendations for the treatment and care of people with early breast cancer (NICE)
  • Cobra awarded £2.6m from Innovate UK for expansion (PharmaTimes)
  • NICE backs trial of online programme for depression (PharmaTimes)
  • SillaJen expands oncolytic virus deal with ABL at 'experienced' facility in France (BioPharmaReporter)
  • EudraVigilance system v.1.4 release notes  (EMA)
  • Competent Authorities on Substances of Human Origin Expert Group (CASoHO E01718) Meeting of the Competent Authorities for Blood and Blood Components (EC)
  • Gecko Biomedical wins $7m French grant for tissue reconstruction tech (MassDevice)
  • Guideline on core SmPC and package leaflet for technetium (99mTc) macrosalb (EMA)



  • NPPA fixes retail price of 5 formulations (Economic Times)
  • Biocon Q3FY18 Revenue at Rs 1092 Crore; EBITDA at Rs 256 Crore; Net Profit at Rs 92 Crore (Press)

Other International

  • Draft thirteenth general programme of work, 2019–2023  (WHO)
  • New WHO Public Assessment Reports (WHOPARs) published (WHO)
  • Trans-Pacific Partnership Becoming a Reality (Patent Docs)
  • PAHO Commission on Equity and Health Inequalities in the Americas meets with officials and civil society in Trinidad and Tobago (PAHO)

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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