Regulatory Recon: Japan Plans 50% Price Cut for Opdivo Roche Forms $100M Global Immunotherapy Network (15 November 2016)

Posted 15 November 2016 | By Michael Mezher 

Regulatory Recon: Japan Plans 50% Price Cut for Opdivo Roche Forms $100M Global Immunotherapy Network (15 November 2016)

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

In Focus: US

  • Genentech's Shocking $2 Billion 340B Revelation (Drug Channels)
  • FDA Willing To Meet With Sponsors On Epinephrine Auto-Injector OTC Switch (IHP-$)
  • FDA Questions Need for Looser Off-Label Promotion Restrictions (Focus) (Drug and Device Law) (Ropes & Gray 1, 2)
  • Trump should be good medicine for the pharmaceutical industry. Here's why (STAT)
  • Donald Trump Can't Prop Up Drug Prices (Bloomberg)
  • Pharma's Not Off the Hook for High Drug Prices (Bloomberg)
  • Open Letter to Congress: Harmful Unintended Consequences of the CREATES Act of 2016 (Letter)
  • Drug firms need to tackle affordability (The BMJ)
  • Why Pharma Needs To Invest In Discovery (Forbes)
  • Payers Want Access To US FDA's Pre-Submission Meetings (Pink Sheet-$)
  • Why Keeping Only the Popular Parts of Obamacare Won't Work (NYTimes)
  • TPP's Death Won't Help the American Middle Class (The Atlantic)
  • GOP Mulls Path on Device Tax Repeal After Trump Victory (Bloomberg)
  • Corbus Pharma Bear Thesis Is Alive and Well on Sclerosis Drug Data Skewed Positive (The Street)
  • Ex-InterMune executive, friend found liable for insider trading (Reuters)
  • Industry Groups Call for Clarity in New 510(k) Device Modifications Guidance (Focus)
  • Mylan And Mabion Reach Agreement On Rituximab Biosimilar (Big Molecule Watch)
  • FDA's Promotional Enforcement Still Playing It Safe (Pink Sheet-$)
  • CMS Updates Drug Pricing Dashboard, Calls for Affordable and Accessible Pharmaceuticals (Focus)
  • Study Suggests Heart-Disease Patients May Need Fewer Blood Thinners (WSJ)
  • Clinical Trial for Long-Lasting Injectable Opioid Dependence Treatment Succeeds (WSJ)
  • Outlook for Pediatric Drug Development Looks Promising (Tufts CSDD)
  • Understanding Financial Toxicity (Harvard Bill of Health)
  • Pfizer and FDA: Expedited regulatory pathways ignore manufacturing burdens (InPharmaTechnologist)
  • Why is that salesman in the operating room for your knee replacement? (Washington Post)

In Focus: International

  • NICE minded not to recommend Teva's asthma biologic (PharmaTimes)
  • Roche launches cancer immunotherapy research network (Reuters) (Fierce) (Press)
  • The Novartis house that Vasella built gets extreme makeover (Reuters)
  • Japan Delays Keytruda Pricing Amid PD-1 Cost Concerns (Pink Sheet-$)
  • Opdivo's NHI Price-Based Sales Put at Over 151 Billion Yen; 50% Cut Likely to Take Effect Feb. 1 (PharmaJapan)
  • Pharma Firms Fear Diminished Role In Revised EU Signal Detection Guideline (Pink Sheet-$)
  • Disgraced stem-cell entrepreneur under fresh investigation (Nature)
  • Bayer Warns Planned German Price Curbs May Restrict Drug Access (Bloomberg) (Fierce) (FDANews-$)
  • UK launch for premature ejaculation spray (PharmaTimes)
  • Saudi FDA Allows "Compassionate Use" Program for Some Medical Devices (Emergo)
  • Lilly's Sarcoma Drug Likely To Be Used Widely Despite EU Conditional OK (SCRIP-$)
  • Cancer drug pricing in Europe (Healthcare Economist)
  • Rwanda feels the pinch as donors slash health aid (Nature)
  • What to do if a Device Manufacturer's Notified Body Halts Operations? France's ANSM Explains (Focus)
  • Stryker signs on for 20-year hitch in Indo UK Institute of Health's Medicity program (MassDevice)
  • What Trump means for European pharma — the long view (PharmaLetter-$)
  • Teva's Rimsa Plant Halted Production, Laid Off Workers (Pharmaceutical Manufacturing)
  • China's Uni-Bio Science, Luqa Pharmaceuticals ink deal for dermatology drug-device combos (Drug Delivery)

US: Pharmaceuticals & Biotechnology

  • Pfenex: consistently high manufacturing quality key for biosimilar success (BioPharmaReporter)
  • Pfizer links up with NCI on cancer research (PharmaLetter-$)
  • FDA Approves Itrafungol, a New Animal Drug for Treating Ringworm in Cats (FDA)
  • Valeant, drug price debates and the innovation spectrum (MedCityNews)
  • FDA Seeks Senior Biomedical Research Service - Analytic and Benefit-Risk Assessment Lead (FDA)
  • Biotech Trumps pharma (BioCentury)
  • Cell Medica and Baylor extend partnership for off-the-shelf T Cells (BioPharmaReporter)

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

  • Pfizer Announces Results from Phase 3 OPAL Clinical Development Program Investigating XELJANZ® (Tofacitinib Citrate) for Psoriatic Arthritis (Press)
  • Novartis gets speedy FDA review for midostaurin (PMLive)
  • Bayer's Xarelto shows effectiveness in reducing the risk of bleeding in patients with irregular heartbeat after percutaneous coronary intervention (Seeking Alpha)
  • Results of Study of Febuxostat on the Frequency of Acute Gout Flares in Early Gout (Press)
  • Octapharma Announces Two Hemophilia A Clinical Trials to Utilize WILATE® (Press)
  • Cytori Granted FDA Orphan Drug Designation for ECCS-50 in Scleroderma (Press)
  • Phase 2 Data for Selonsertib in Nonalcoholic Steatohepatitis (NASH) Presented at The Liver Meeting® 2016 (Press)
  • Centrexion Therapeutics Announces Fast Track Designation Granted by FDA to CNTX-4975 for Treatment of Morton's Neuroma (Press)
  • ACADIA Pharmaceuticals Initiates Phase II Trial of Pimavanserin for Adjunctive Treatment in Patients With Negative Symptoms of Schizophrenia (Press)

US: Medical Devices

  • How Much Risk Will Patients Accept? (MDDI)
  • Top Takeaways from FDA Draft Guidance on Software as Medical Device (National Law Review)
  • Large joint procedure volumes rose 6% last year in US registry (MassDevice)
  • Why conduct clinical vendor audits? (MassDevice)
  • St. Jude wins MRI nod for Proclaim Elite spinal cord stim (MassDevice)
  • FDA clears CapsoVision's CapsoCam Plus for small bowel endoscopy (MassDevice)
  • FDA clears Channel Medical Cerene endometrial ablation trial (MassDevice)
  • Medtronic Receives FDA Approval for Claria MRI(TM) Quad Cardiac Resynchronization Therapy Defibrillator (Press)
  • Final Patient Enrolled for Iliofemoral Venous Stent Study (Press)
  • Medtronic to Unveil Data Supporting Endovascular Treatments for Aortic Disease at VEITHsymposium 2016 (Press)
  • NIH-led effort examines use of big data for infectious disease surveillance (NIH)

US: Assorted & Government

  • House Energy & Commerce Committee Moves Four Health-Related Bills Forward (E&C)
  • Medicaid Rebate Update: (1) CMS Delays Expansion of Program to Territories; (2) CMS Issues Revised Medicaid Drug Rebate Agreement, but Will Affordable Care Act Changes to Rebate Program Survive Trump Administration? (FDA Law Blog)
  • Impax Investor Says Drug Price-Fixing Probe Never Disclosed (Law360-$)
  • Justices Won't Hear Drugmakers' OxyContin Patent Appeal (Law360-$)
  • Doc wins $20m from Medtronic in spine patents spat (MassDevice)
  • Ninth Circuit Considers Limits to DEA Access to Oregon Prescription Drug Monitoring Program (National Law Review)
  • Supplement Group: FDA Move To Ban Vinpocetine Is 'Legally Deficient' (IHP-$)

Upcoming Meetings & Events


  • Clinical researchers: refocus on your processes and team relationships (PharmaTimes)
  • ERYTECH Announces Withdrawal of Its European Marketing Authorization Application for GRASPA for Acute Lymphoblastic Leukemia and Prepares for Resubmission (Press)
  • Civil Society representatives: Call for expressions of interest for the EMA CAT Committee (EC)
  • Ignyta Announces EAP Designation and CE Marking for its Trailblaze Pharos Clinical Trial Assay (Press)
  • Switzerland's SFS Group to acquire contract manufacturer Tegra Medical (MedicalDesign&Outsourcing)
  • Dementia now leading cause of death in England and Wales (OnMedica)


  • India's needs for affordable and essential diabetes medicines (PharmaLetter-$)
  • CDSCO Publishes Online List of NABL Accredited Labs and WHO-GMP/COPP holders (CDSCO)
  • Confusion among chemists adds to the pain of consumers (Economic Times)
  • Sun Pharma, others ink pact for malaria project in Mandla (Economic Times)
  • Amidst crisis, Tata Group's pharma unit Advinus Therapeutics lays off 50 people (Economic Times)


  • PMDA November Newsletter (PMDA)
  • Asian countries pledge to overcome antimicrobial resistance (BioSpectrum)
  • Taiwan govt's new plans to bolster the biomedical sector (BioSpectrum)
  • Japan's Towa Phamaceuticals to enter the US market (BioSpectrum)


  • Philips launches world's 1st detector-based spectral CT scanner in Canada (MassDevice)


  • Australia Needs Stronger Leadership For Biotech To Prosper (SCRIP-$)



  • Zika Infection in U.S. Is Still Rare So Far, Blood Donations Indicate (NYTimes)

General Health & Other Interesting Articles

  • Is The American Heart Association Trying To Kill Health Reporters? (CardioBrief)

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.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles