Regulatory Focus™ > News Articles > Regulatory Recon: Merck's Keytruda Approved for First Line NSCLC; PhRMA Banks $100m Ahead of Pricing

Regulatory Recon: Merck's Keytruda Approved for First Line NSCLC PhRMA Banks $100m Ahead of Pricing Fight (25 October 2016)

Posted 25 October 2016 | By Michael Mezher 

Regulatory Recon: Merck's Keytruda Approved for First Line NSCLC PhRMA Banks $100m Ahead of Pricing Fight (25 October 2016)

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

In Focus: US

  • Regulatory Misconduct: FDA Launches Website For Allegations Against Device Manufacturers (Focus)
  • Merck Drug Gets FDA Approval as a First-Line Lung Cancer Treatment (WSJ) (Press)
  • Drug lobby adds $100M to war chest ahead of pricing battle (Politico)
  • FDA's Opioids Action Plan: A Midyear Checkup (FDA Voice)
  • Generic drug makers challenge FDA plan to withdraw their ADHD pills (InPharmaTechnologist) (STAT)
  • Biosimilar Interchangeability Guidelines on Track for 2016 Release, Woodcock Says (FDANews-$)
  • Drugmakers Criticize FDA's Plan To Research Animation In DTC Drug Ads (Focus)
  • Why the U.S. Still Trails Many Wealthy Nations in Access to Care (NYTimes)
  • U.S. government says benchmark 2017 premiums up 25 percent (Reuters) (NPR)
  • Newt Gingrich is the new face of a controversial opioid addiction therapy (Washington Post)
  • Faith-Based Investor Group Calls for Drugmakers to Be Transparent on Pricing (WSJ)
  • Government Files Brief In House v. Burwell; ASPE Lays Out 2017 Plans And Premiums (Health Affairs Blog)
  • In a Veloxis-Like Analysis, FDA Rules That EMBEDA 3-Year Exclusivity Does Not Block MORPHABOND 505(b)(2) Approval (FDA Law Blog)
  • FDA Issues Amendments to Regulations on Ozone Depleting Substances (Direct Final Rule, ProposedRules)

In Focus: International

  • UK Report Calls For Streamlining To Accelerate Access To Drugs By Four Years (Focus) (PharmaTimes)
  • Patient Registries: EMA Wants To Make Better Use Of Medicines Data (Focus)
  • EMA Sets Deadlines For 2016 Type I Variations (Focus)
  • Abbott Defines Bullishness On India (SCRIP-$)
  • Pfizer cuts price of Enbrel to match rival 'biosimilar' drug (Irish Times)
  • UK MPs On Brexit: EMA And MHRA Are 'Completely Intermingled' (Pink Sheet-$)
  • India Supreme Court to hear government's petitions to transfer drug ban cases (Economic Times)
  • Novartis promises a speedy CAR-T pitch, boasts about its slate of blockbusters-to-be (Endpoints)
  • With no big M&A on tap, Novartis presses pause on $12B-plus Roche stake sale: Sonntagszeitung (Fierce)
  • UK radiotherapy upgrade 'changes face of cancer treatment' (Financial Times) (PharmaTimes)
  • Dr Reddy's Laboratories profits drop 60% (Pharmafile)
  • ICH to Revise 16-Year-Old Pediatric Drug Development Guideline (FDA News-$)
  • Korea Plans Breakthrough System To Encourage Innovation (Pink Sheet-$)
  • Antibiotic waste is polluting India and China's rivers; big pharma must act (The Guardian)
  • Biotrial says Le Figaro coverage of BIA 10-2474 trial is "smear campaign" (InPharmaTechnologist)
  • Unicef Cuts Cost of Vaccine That Protects Against 5 Diseases (NYTimes)
  • NICE recommends screening for Lynch syndrome (PharmaTimes)

US: Pharmaceuticals & Biotechnology

  • Soon-Shiong swoops in on Benitec for PhII gene-silencing data (Fierce)
  • Lilly's history lesson (BioCentury)
  • FDA Tackles Cellular, Gene Therapies (PharmTech)
  • Pharma 'could do better' on social media engagement (PMLive)
  • FDA Plans to "NIPP" it in the BUD (Lachman Consultants)
  • OGD Director Provides Update on Generic Program at GPhA Fall Technical Conference (Lachman Consultants)
  • Depression drugs sales in the USA will reach $4.6 billion by 2025, report (PharmaLetter-$)
  • Francer Tapped As New GPhA Counsel Following Stint At PhRMA (Inside Health Policy-$) (Pink Sheet-$)
  • Complex ANDAs To Be Allowed Pre-Submission Product Meetings (Pink Sheet-$)
  • Biosimilar Prescribing Decisions May Depend Upon Disease State (Pink Sheet-$)
  • Guideline created for 'transparent and complete' clinical trial reporting (OutsourcingPharma)
  • Global Blood, FDA agree on Phase III design (BioCentury)
  • Fact-checking Bernie Sanders' claim about Big Pharma, Prop 61 on the Real Time with Bill Maher (MedCityNews)
  • Defense Department grants AI pharma company access to breast cancer tissue samples (Modern Healthcare)
  • Can The Placebo Effect Really Work Without Deception? Maybe, Maybe Not (Forbes)
  • JAMA, FDA expert hit out at Sarepta's 'worrisome model' for approval (Fierce) (JAMA)
  • IBM CEO on Watson's latest answers for fighting cancer (CBS)

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

  • Advaxis posts updated data from small, interrupted cervical cancer study (Fierce)
  • Agilent Technologies Receives Expanded FDA Approval for Use of Dako PD-L1 IHC 22C3 pharmDx Companion Diagnostic in Non-Small Cell Lung Cancer (NSCLC) (Press)
  • Cytori touts regenerative cell therapy data (Drug Delivery)
  • Alzheon Publishes New Analyses from Phase 3 Studies Showing Clinical Benefit of Tramiprosate in Alzheimer's Patients Who Are Carriers of APOE4, the Major Genetic Risk Factor in up to 65 Percent of Alzheimer's Patients (Press)
  • GBT heads into Ph III, pivotal testing for sickle cell candidate (Fierce)
  • Alphamab starts Phase I infertility study (BioCentury)
  • FDA Grants Orphan Drug Status to Novel Hepatocellular Carcinoma Tx (MPR)

US: Medical Devices

  • Hired experts back claims St. Jude heart devices can be hacked (Reuters)
  • MDUFA IV: From Growing Pains to Greater Commitments (MDDI)
  • FDA Clears Immucor Blood Compatibility Test for Sickle Cell Trait (GenomeWeb)
  • New Details Published on How Doctors, Patients Use Genomic Health's Breast Cancer Test (GenomeWeb)
  • Startup's new approach to health IT cybersecurity succeeds on Kickstarter (MedCityNews)
  • Harvard touts 1st 3D-printed organ-on-a-chip with integrated sensing (MassDevice)
  • Medtronic Receives FDA Clearance of New Lower Profile HawkOne 6F Directional Atherectomy System (Press)
  • Melinta Therapeutics files Baxdela NDAs for hospital-treated skin infections (PharmaLetter-$)
  • Baxter Reports Third Quarter 2016 Results and Increases Financial Outlook For Full-Year 2016 (Press)
  • HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall - Contamination Causing Electrical Issues (FDA)
  • St. Jude Medical Recalls Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) Due to Premature Battery Depletion (FDA)

US: Assorted & Government

  • Life Care to pay record $145 million over false claims (Reuters)
  • Texas hospital reaches settlement with nurse infected with Ebola (Reuters)
  • ACA Deadline Extended for Those Who Lost Their Health Plans (WSJ)
  • Pfizer Can't Shake Damages Expert In Trade Secrets Trial (Law360-$)
  • Teva's Generic Overdose Drug Application Sparks IP Suit (Law360-$)
  • Researchers Claim No Defamation In St. Jude Security Report (Law360-$)
  • Zimmer Gets Quick Win In 2nd Knee Implant Defect Bellwether (Law360-$)
  • R.I.P. Frye (Drug and Device Law)

Upcoming Meetings & Events


  • MEMBER STATE DATA on cross-border healthcare following Directive 2011/24/EU(EC)
  • European Commission Question & Answer Document For Patients Builds Trust And Understanding On Biosimilar Medicines Across Europe (Medicines for Europe)
  • Response to publication of the Accelerated Access Review (ABPI)
  • MRC awards £4.3m to boost UK research base in dementia (MRC)
  • EFPIA Welcomes Second EUIPO/EPO Report As Clear Evidence of IPR-Intensive Industries' Significant Value to the EU Economy (EFPIA)
  • The new Royal Decree Law allows for a 19% time reduction when starting a new clinical trial in Spain (PharmaLetter-$)
  • Spain's PharmaMar opens new business in Austria (PharmaLetterb-$)
  • Martindale's oral epilepsy drug bags EU nods (PharmaTimes)
  • All NHS trusts in England now offering research to patients (PharmaTimes)
  • Svelte Medical wins CE Mark for Direct coronary stent (MassDevice)


  • Discovery of Blood Biomarkers for Early Pancreatic Cancer Detection (AMED)
  • Turkish Call For Moves To Support Industry 'Independence' (SCRIP-$)
  • Bangladeshi Beximco Receives Second FDA Approval (PharmaLetter-$)
  • Daiichi Presses On With Lead Pexidartinib Trial Despite Liver Toxicity (SCRIP-$)
  • Chinese VC to inject $30M into Pluristem Therapeutics (Fierce)


  • Indian Regulators Open Comment Period for Proposed Medical Device Rules (Emergo)
  • Wanbury export issue shows regulator miscommunication (Economic Times)
  • Glenmark Pharma gets USFDA nod for anti-fungal ointment (Economic Times)
  • Everstone buys Mumbai-based drug tech firm Rubicon for Rs 220-crore (Economic Times)


  • Add or remove a connection to your manufacturing organisation (TGA)


  • Summary Safety Review - Levetiracetam and Methotrexate - Assessing the Potential Risk of Drug-Drug Interaction (Health Canada)
  • Concordia founder resigns and will step down once replacement found (Pharmafile)


  • FDA Questions Missouri Lab Over Unauthorized Zika Tests (FDA)

    General Health & Other Interesting Articles

    • Pediatricians Release New Guidance For Preventing Sudden Infant Deaths (NPR)
    • Calcium Levels and CV Risk: New Study Finds No Link (CardioBrief)
    • Effect of Short-Term vs. Long-Term Blood Storage on Mortality after Transfusion (NEJM)
    • CMV Is a Greater Threat to Infants Than Zika, but Far Less Often Discussed (NYTimes)

    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

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