Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves BMS' Opdivo for Bladder Cancer; India Publishes New Medical Device Ru

Regulatory Recon: FDA Approves BMS' Opdivo for Bladder Cancer India Publishes New Medical Device Rules (3 February 2017)

Posted 03 February 2017 | By Michael Mezher 

Regulatory Recon: FDA Approves BMS' Opdivo for Bladder Cancer India Publishes New Medical Device Rules (3 February 2017)

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

In Focus: US

  • Biogen Reveals Federal Investigation Into Price Reporting and Rebate Payments (The Street)
  • FDA Approves BMS' Opdivo for Bladder Cancer (BioCentury) (Reuters) (PharmaTimes) (Press)
  • Amgen's 27,000 Patient PCSK9 Inhibitor Trial Meets Main Endpoints (CardioBrief) (Reuters) (The Street)
  • Drug Pricing Bill May Make Six-Month ANDA Review Slower Than Eight-Month Review (Pink Sheet-$)
  • BMS, Economist Intelligence Unit Launch Site on Cancer Survivorship (Economist) (BMS)
  • Small Biopharma Face Distinct Challenges: FDA Official and Sanofi Genzyme SVP Argue (Focus)
  • Trump Signals Support for 'Right-to-Try' Movement (Focus)
  • New House E&C Chairman to Consider Value-Based Drug Price Negotiations (Focus)
  • Bi-partisan Congressional Caucus Re-Launched to Combat Prescription Drug Abuse (Press)
  • California lawmaker wants to limit use of those coupons people use for high-cost drugs (LA Times)
  • Pfizer Said to Hire JPMorgan to Weigh $2 Billion Portfolio Sale (Bloomberg)
  • Generic Drugmaker Sues FDA to Get Its Exclusivity Back (Bloomberg)
  • GOP Campaign to Repeal Obamacare Stalls on the Details (NYTimes)
  • Cures Act, FDA Draft Guidance Suggest Flexibility On Communication Of Real-World Drug Impacts, Though Questions Remain (Health Affairs Blog)
  • NIH to expand critical catalog for genomics research (NIH)
  • Insurer UHC Will Cover Biogen Spine Drug, But With Limits And Proof (Xconomy)
  • CDER's 50 Open Leadership Posts Could Be Bigger Hiring Challenges After Trump Freeze (Pink Sheet-$)
  • Novo Nordisk CEO on Pricing, US Investments, M&A (Bloomberg)
  • FDA Claims Sole Authority Over Naming Of US-Licensed Biologics (Pink Sheet-$)
  • Novo Nordisk cuts profit outlook on higher US political risks (Financial Times)
  • Trump's vaccine views are at odds with those of most Americans, study says (Washington Post)

In Focus: International

  • Indian Regulators Publish New Medical Device Rules (Emergo) (PharmaBiz)
  • Brexit plan published in government White Paper (BBC) (ABPI)
  • UK agency says Pfizer breast cancer drug too expensive (Reuters) (PharmaTimes) (Pharmafile) (ABPI)
  • EU Pharma Groups Joint Statement on Shortages (Medicines for Europe)
  • CDSCO Details its Steps to Reduce Antimicrobial Resistance (CDSCO)
  • European Regulatory Roundup: Lead Brexiteer Muddies Waters on UK-EMA Relationship (Focus)
  • MEPs And Health Advocates Pile The Pressure On EU Drug Pricing (Pink Sheet-$) (EurActiv)
  • Laying The Groundwork For Value-Based Healthcare In Europe (SCRIP-$)
  • Roche's Immuno-Oncology Therapy On Course To Indian Debut? (Pink Sheet-$)
  • Drug prices in Russia may increase by 20%-25% due to new labelling requirements (PharmaLetter-$)
  • Japan IP High Court Rules In Lilly's Favor On Alimta Vitamin Regimen Patents (Press)

US: Pharmaceuticals & Biotechnology

  • FDA: Common Antiseptic Tied to Severe Allergic Reactions (Medpage) (FDA 1, 2)
  • Rogue FDA Tweeters Archive Inspection Data, Fearing Deletion By Trump (Pink Sheet-$)
  • Former OND leader Jenkins joins Greenleaf (BioCentury)
  • AstraZeneca pulls PD-L1 phase 3 combo test, RSV candidate (Fierce)
  • Poor medication adherence in clinical trials: consequences and solutions (Nature)
  • FDA Generic Approvals May Have Dipped in January? (Lachman Consultants)
  • Opioid addiction implant maker Braeburn Pharma pulls IPO (Reuters)
  • Roche powers up for first-line lung duel (EPVantage)
  • Mannkind in Free Fall After Changes to Insulin Product, Sales Force (The Street)
  • Bob Langer on drug delivery (Drug Delivery)
  • FDA Issues Six Deferral Decisions for Final Health Care Antiseptic OTC Drug Monograph Ingredients (FDA Law Blog)
  • J&J invests in Caelus, pens pacts to grow microbiome R&D (Fierce)
  • Big data study finds new targets for breast cancer treatment (PharmaTimes)
  • Chutes & Ladders: Genentech oncology head jumps ship (Fierce)
  • Fake Harvoni trail leads to 'cash-only wholesalers' (Securing Industry)
  • Teva confirms generic Victoza patent challenge (PharmaLetter-$)
  • Merck launches first TV advertising for cruising Keytruda in lung cancer (Fierce)
  • Chinese CDMO group buys New Jersey J-STAR for $26m (Outsourcing Pharma)
  • TapImmune improves T-cell vaccine formulation ahead of Ph II trials (BioPharmaReporter)

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

  • Early data indicate efficacy of Targovax immuno-oncology candidate (PharmaLetter-$)
  • FDA Accepts Two sBLAs for Merck's KEYTRUDA® (pembrolizumab) for Locally Advanced or Metastatic Urothelial Cancer in Cisplatin-Ineligible First-Line and Second-Line Post-Platinum Failure Treatment Settings (Press)
  • Lysogene Receives Orphan Drug Designation from FDA for LYS-GM101 for treatment of GM1 Gangliosidosis (Press)
  • Alnylam Presents New Data on Fitusiran at EAHAD (Press)
  • Aviragen takes a tumble as RSV drug fails mid-stage trial (Fierce)
  • Bluebird bio Announces First Patient Treated with LentiGlobinTM Drug Product Under Amended Study Protocol in HGB-206 Phase 1 Study of Patients with Severe Sickle Cell Disease (Press)

US: Medical Devices

  • Johnson & Johnson medical device chief Pruden to step down (MassDevice)
  • Your Top 10 Questions About ISO 13485:2016—Answered! (GxPLifeline)
  • How to go from idea to commercialization: Interview with Dr. Marie Johnson, Founder of AUM Cardiovascular (MassDevice)
  • Lantheus wins FDA nod for Definity imaging agent label update (MassDevice)
  • Elekta wins FDA 510(k) clearance for Venezia gynecological brachytherapy applicator (MassDevice)

US: Assorted & Government

  • Just What the Doctor Ordered: Package Insert Does not Establish Standard of Medical Care (Drug & Device Law)
  • Chemists' Lives Upended by Trump Travel Ban (C&EN)
  • Cigna adds to insurers' pressure on lawmakers for Obamacare fixes (Reuters)
  • Employers Fret Job-Based Coverage Vulnerable To Fallout From GOP Health Overhaul (KHN)
  • Trump administration proposes new Obamacare regulation that could make 'special enrollments' tougher (CNBC)

Upcoming Meetings & Events


  • Immunotherapy treatment fast-tracked under UK's access to medicines scheme (EPR)
  • Arix files for £100M IPO to invest in early-stage biotechs (Fierce)
  • NICE to bring HTA processes to mobile health apps (PMLive)
  • Pressure BioSciences Lands CE Mark for NGS Sample Prep Instrument (GenomeWeb)
  • Second Sight wins German reimbursement for Argus II retinal prosthesis (MassDevice)



  • Indian vaccine industry perched on competitive advantage & technical capability: Pushpa Vijayaraghavan (PharmaBiz)
  • Lupin gets final USFDA nod for Mylan's skin disease cream (Economic Times)
  • Will not sell sick pharma firms to foreign companies: Government (Economic Times)


  • Consultation: Further proposed amendments to the Poisons Standard - Joint ACCS and ACMS meeting, and ACCS meeting, March 2017 (TGA)


  • Release of International Council on Harmonisation (ICH) Document: Good Clinical Practice (GCP) "Renovation" Reflection Paper (Health Canada)

General Health & Other Interesting Articles

  • Improving the Health of the United States With a "Winnable Battles" Initiative (JAMA)
  • Cancer rates set to increase six times faster in women than men (The Guardian)

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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