Regulatory Recon: NICE Says No to BMS' Opdivo for Head and Neck Cancer; SEC Targets Fake Biotech Stock News (11 April 2017)

Posted 11 April 2017 By Michael Mezher

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

In Focus: US

  • Nine blockbuster drugs to watch are making their debut, aiming at a $16B prize in 2021 (Endpoints) (Report)
  • Merck's CEO doubles his pay (Axios)
  • Congress Seeks a Statutory Fix to Stymied Off-Label Discussions (FDA Law Blog)
  • FDA, industry fear wave of medical-device hacks (The Hill)
  • Get ready for the biosimilar showdown (Politico)
  • Drug Industry May Face New Areas of Antitrust Scrutiny (Bloomberg)
  • Large Majority of Prescription Drug Corporation CEOs Will Not Commit to Limiting Price Increases (Public Citizen)
  • 'FAST' Generics Act Seeks to Thwart Abuse of FDA Safety Programs (Focus)
  • Mission bags Fox Foundation grant for Parkinson's program (Fierce)
  • Stanford Team Says Illumina-Sequenced Data Could Be Compromised (BioCentury)
  • Maryland Lawmakers Pass Generic Drug Price Gouging Bill (Focus)
  • Trump Administration to Pay Health Law Subsidies Disputed by House (NYTimes)
  • SEC targets fake stock news on financial websites (Reuters)
  • GOP Bills To Replace Obamacare Do Not Tinker With Lawmakers' Coverage (KHN)
  • How US Health Care Became Big Business (NPR)
  • Toward Responsible Human Genome Editing (JAMA)
  • The first live-attenuated vaccine candidate completely protects against Zika infection in Mice (UTMB) (Nature)
  • Are US blood donations safe from Zika? (CBS)
  • George Church gives a sneak peek of his March for Science speech (STAT)

In Focus: International

  • NICE turns down Bristol's Opdivo for head and neck cancer (Reuters) (PharmaTimes) (Pharmafile)
  • SMC u-turn backs Roche's Kadcyla for breast cancer (PharmaTimes)
  • Scotland first UK nation to routinely offer HIV PrEP (PharmaTimes)
  • Scotland recommends Janssen's Imbruvica for leukaemia (Pharmafile)
  • CFDA Simplifies Approval Procedures for Drugs and Devices (Lexology)
  • EMA Board Adopts New Policy on Whistleblowing (Focus)
  • Billion-dollar boost sought for Canadian science (Nature)
  • IMDRF Offers New Guideline on Adverse Event Reporting (Focus)
  • EMA Looks to Revise Guideline on Investigation Drug Interactions (Focus)
  • 56 Biosimilars In Late-Stage Development Line Up To Challenge Top Biologic Drugs (SCRIP-$)
  • Trials and Tribulations: The impact of new clinical trial regulation in Europe (Pharmafile)
  • Turkish pharma major kicks off diabetes and hepatitis exports from Kazakhstan (PharmaLetter-$)
  • Pharma Welcomes Clarity On Similarity Assessment Of ATMPs Under EU Orphan Law (Pink Sheet-$)
  • Boehringer, Sanofi Must Divest To Clear $24B Deal In Mexico (Law360-$)
  • In Australia, a new project aims to bring industry and academia closer together (PharmaLetter-$)
  • Egypt and India ties in pharmaceuticals encouraged (Pharmafile)
  • Nature Trade Secrets Monthly Map: UK, Germany, Kenya, Mauritius, Mozambique (Nature)
  • Breaking Down Barcode Barriers (MDDI)
  • European Medicines Agency closed 13-17 April 2017 (EMA)

US: Pharmaceuticals & Biotechnology

  • Parker Institute researchers publish first major scientific paper in Nature (Press)
  • 5 trends shaping rare disease drug development (BioPharmaDive)
  • Bioverativ installs new EVP of R&D (Pharmafile)
  • Johnson & Johnson hangs fire on Geron decision after latest data review (Fierce)
  • Fighting Parasitic Infections: Promise in Cyclic Peptides (NIH)
  • Biohaven Planning $100M IPO (BioCentury)
  • AbbVie's Humira needs a discount, ICER says, warning Lilly, Sanofi to price with care (Fierce)
  • Our Exclusive 2021 Outlook for Specialty Pharmacy Prescription Revenues (Drug Channels)
  • Perspectives On Health Reform, User Fees With Cowen's Chris Krueger (Pink Sheet-$)
  • Tumor Mutation Burden Biomarker Emerges In Bristol's '026 Lung Cancer Post Mortem (Pink Sheet-$)
  • When is bad press not so bad? When it's building a market, AstraZeneca says of its Super Bowl experiment (Fierce)
  • Finding the trends behind the figures – what pharma's financial results reveal about where the industry is heading (PharmaLetter-$)

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

  • Nicox announces PDUFA date for ZERVIATE NDA (Press)
  • Bristol-Myers Squibb and Apexigen, Inc. Announce Clinical Collaboration to Evaluate Opdivo (nivolumab) in Combination with APX005M in Advanced Solid Tumors (Press)
  • Inotek Completes Patient Recruitment in Phase 2 Trial of a Fixed-dose Combination (FDC) of Trabodenoson and Latanoprost (Press)
  • ArQule Receives Clearance of Investigational New Drug Application from the FDA for Proprietary Reversible BTK Inhibitor, ARQ 531 (Press)

US: Medical Devices

  • Medtech Startup Showdown 2017: Final Round (MDDI)
  • Avinger to lay of a third of workforce (MassDevice)
  • FDA clears Bluetooth BP monitor, 7-day wearable ECG, and two other digital health products (mobihealthnews)
  • Cytori wins FDA nod for cell therapy pilot trial (MassDevice)
  • Medizone to pursue FDA 510(k) for AsepticSure (MassDevice)
  • Inari Medical wins FDA nod for ClotTriever peripheral thrombectomy device (MassDevice)
  • Alere Achieves FDA Clearance for Alere Reader Platform and Alere BinaxNOW Influenza A & B Card 2 (Press)

US: Assorted & Government

  • MITA & CORAR Support House Bill To Foster Access To Innovative Medical Imaging (MITA)
  • How Should The Trump Administration Handle Medicare's New Bundled Payment Programs? (Health Affairs Blog)
  • Medicare Provider Education: Oversight of Efforts to Reduce Improper Billing Needs Improvement (GAO)
  • PTAB Update -- Shire Has Rare Motion to Amend Granted (Patent Docs)
  • Shire Scorches FTC Suit Over Anti-Generic Petitions (Law360-$)
  • Fed. Circ. Affirms Takeda Loss In Prevacid Patent Case (Law360-$)
  • Abbott Admitted To Depakote Mislabeling, MDL Court Told (Law360-$)
  • Pharmaceutical Co. Gets Quick Win in PCB Contamination Suit (Law360-$)

Upcoming Meetings & Events

Europe

  • Intellia Therapeutics Announces EU Patent Office's Decision to Grant CRISPR/Cas9 Genome Editing Technology (Press)
  • Where's the Brexit? UK clinical research industry charts path ahead of EU withdrawal (OutsourcingPharma)
  • Online forum reveals UK users may stop taking stroke-prevention pills (Reuters)

Asia

  • CFDA Vice Minister Wu Zhen meets the delegation from the World Health Organization (CFDA)
  • Janssen becomes PeptiDream's latest partner in ten-figure deal (PharmaLetter-$)
  • NuBiyota pact continues Takeda's GI, microbiome deal blitz (Fierce)
  • Sumitomo Dainippon buys cell therapy processing tech from Hitachi (InPharmaTechnologist)

India

  • Hilleman labs partners with Indian Government for shigella vaccine (Pharmafile)
  • Indian Panel Solicits Input on Drug Price Controls (CDSCO)
  • CDSCO to Host Meeting on Online Registration for Notified Bodies (CDSCO)
  • Centre issues medical 'alert' on bio-resorbable stents (Economic Times)
  • Industry bodies want separate ministry for pharma, oppose shifting of NPPA, DoP to health ministry (PharmaBiz)
  • PvPI of India leads ahead of 149 countries in drug quality as per ICSR submitted to WHO-UMC centre (PharmaBiz)

Canada

  • Canada to introduce legal marijuana legislation Thursday: source (Reuters)
  • Summary Safety Review - Hospital Beds - Assessing the Potential Risk of Patient Entrapment (Health Canada)
  • Canadian government, JDRF ink $30m partnership to support diabetes research (Drug Delivery)
  • Valeo Pharma and Zambon Form Partnership for Parkinson's Disease Treatment Xadago® (safinamide) in Canada (Press)

Australia

  • Austrian biotech Themis launches Zika vaccine clinical trial (Reuters)

Other International

  • Brazil: Courts Confirm Preliminary Injunction Based on Pending Patent Applications (National Law Review)

General Health & Other Interesting Articles

  • The Patients Were Saved. That's Why the Families Are Suing. (NYTimes)
  • Stroke hospitalizations rising among younger US adults (Reuters)
  • Physician recommendations about breast cancer screening vary, survey finds (Washington Post)
  • New Official Prostate Cancer Screening Guidelines Announced: Too Little, Too Late? (Forbes) (NPR)

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 news@raps.org.

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

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