Regulatory Focus™ > News Articles > 2019 > 6 > Recon: Merck’s Keytruda Picks up Two New Indications for Head and Neck Cancer

Recon: Merck’s Keytruda Picks up Two New Indications for Head and Neck Cancer

Posted 11 June 2019 | By Michael Mezher 

Recon: Merck’s Keytruda Picks up Two New Indications for Head and Neck Cancer

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Merck's Keytruda wins FDA approval to treat head & neck cancer (Reuters) (Endpoints) (Press) (FDA)
  • Startup offering free DNA sequencing signs first pharma sponsor (STAT)
  • How pharma could benefit from one of Congress’ signature drug pricing ideas (STAT)
  • Jacobus prices its rare disease drug at half of what Catalyst charges, but will doctors prescribe it? (STAT) (Endpoints)
  • JJ&J bags $150M option on Genmab's Darzalex successor (Fierce) (Endpoints) (PMLive) (Press)
  • J&J announce first-of-its-kind portopulmonary hypertension study results (PharmaTimes)
  • FDA Overlooked Red Flags In Drugmaker’s Testing of New Depression Medicine (KHN) (NBC)
  • Biosimilar User Fee Collections Drop Well Below Estimates, But US FDA Not Worried (Pink Sheet-$)
  • FDA weighs role of high-dose opioids as two-day expert meeting begins (BioPharmaDive)
  • Florida governor signs bill for foreign drug importation (Washington Post) (Orlando Sentinel)
  • The rise of unproven billion-dollar health care industries (Axios)
  • A Judge Rules Against One Stem-Cell Clinic. There Are Hundreds of Them. (NYTimes)
  • Tense trade talks shine light on drug supply chain (Politico)
  • Minibus continues to drive forward (Politico)
In Focus: International
  • Russian biologist plans more CRISPR-edited babies (Nature) (Endpoints)
  • Roche catapults Thomas Schinecker to chief of diagnostics unit (Endpoints)
  • AZ’ new headquarters double in price (PharmaTimes)
  • How Japan’s Biggest Biotech Is Pioneering New Peptide-Based Drugs (Forbes)
  • Sun Pharma falls 4% as Goldman Sachs downgrades stock (Economic Times)
  • Orkambi row: government now considering Crown Use licensing (PMLive) (Pharmafile) (Fierce)
  • Imfinzi, Opdivo among latest SMC decisions (PharmaTimes)
  • MHRA gives Bristol Labs the all-clear (Fierce) (Manufacturing Chemist)
  • Why Shanghai’s Brii partnered with microbiome start-up Artizan (BioCentury)
Pharmaceuticals & Biotechnology
  • Daily HIV prevention pill urged for healthy people at risk (STAT)
  • Cymabay’s NASH drug ambitions dealt serious setback with negative study results (STAT) (Endpoints)
  • Heartburn Drugs Can Lead to Fatal Heart or Kidney Disease (NYTimes)
  • AbbVie pads Humira follow-up Skyrizi's blockbuster potential with positive 2-year data (Fierce)
  • BioCelerate Launches Two New Initiatives and Expands Membership (Press)
  • Kit Check Brings Next-Generation Medication Tracking Mainstream with FDA Pilot (Press)
  • The Quality Lowdown: Quality Vision Falls Short At Various US and Indian Facilities (Pink Sheet-$)
  • Eli Lilly's Taltz touts long-term clear skin data after unimpressive first quarter sales (Fierce)
  • ADA: Lilly, Boehringer's DPP-4 drug Tradjenta ties generic rival in heart safety study (Fierce)
  • US FDA's Sentinel To Begin Expansion This Fall (Pink Sheet-$)
  • FDA Moves Compounding Program to Office of Compliance (Focus)
  • Real-World Evidence Sought In Sanofi Pasteur Observational Flu Vaccine Trial (Scrip-$)
  • Stem cell clinics co-opt clinical-trials registry to market unproven therapies, critics say (STAT)
  • Nasdaq delists Insys after bankruptcy filing; China's Zai Lab licenses solid tumor drug from Deciphera (Endpoints)
  • InGeneron Adds $23M to Test Stem Cell Therapy for Rotator Cuff Tears (Xconomy)
  • RSV specialist ReViral hires ex-Dova leader as CEO (Fierce)
  • Teva Pharmaceuticals USA, Inc. Expands Voluntary Nationwide Recall of Losartan Potassium to 50 mg and 100 mg Tablets USP, Sold Exclusively to Golden State Medical Supply, Inc. (FDA)
  • Novartis Pharmaceuticals Corp., et al.; Withdrawal of Approval of Six Abbreviated New Drug Applications (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • AlloVir Announces Viralym-M Granted Regenerative Medicine Advanced Therapy (RMAT) Designation for the Treatment of Hemorrhagic Cystitis Caused by BK Virus in Adults and Children Following Allogeneic HSCT (Press)
  • Genentech’s Gazyva (Obinutuzumab) Delivers Positive Topline Results for Phase II Lupus Nephritis Study (Press)
  • MetVital, Inc. Announces FDA Clearance of Investigational New Drug (IND) Application for AEO for Phase 2 testing for Glioblastoma Multiforme (Press)
Medical Devices
  • Israel's Aidoc gets third FDA nod for AI tools for radiologists (Reuters)
  • Industry Groups Question Aspects of CDRH’s AI/ML-Based SaMD Framework (Focus)
  • Partnership Reveals New Details on Medtronic’s Surgical Robot (MDDI)
  • Medtronic's latest real-world device data, Onduo and Orpyx's expanding partnership and more diabetes news from ADA 2019 (mobihealthnews)
  • Ivenix Infusion System Receives FDA 510(k) Clearance (Press)
  • SpeeDx Receives FDA Breakthrough Device Designation for ResistancePlus® GC (Press)
  • Motus GI Receives FDA Clearance to Market Pure-Vu® GEN2 (Press)
  • Itamar gets FDA-clearance for disposable wearable that tests for sleep apnea (mobihealthnews)
  • Real-World Data from Guardian(TM) Connect and Sugar.IQ(TM) Reveal Improved Diabetes Outcomes (Press)
  • Agilent Companion Diagnostic Gains Expanded FDA Approval in Head and Neck Squamous Cell Carcinoma (HNSCC) (Press)
  • Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records (FDA)
US: Assorted & Government
  • Former Theranos COO Balwani will fight criminal charges (CNBC)
  • Medical marijuana no longer tied to fewer opioid deaths (Reuters)
  • Senators call for HHS probe into CMS genetic testing payments to Chinese-linked companies (BioCentury)
  • Why Bellwethers Matter In The Opioid MDL (Law360-$)
  • The 'Newly Acquired Information' Shift In Pharma Litigation (Law360-$)
  • Thermo Fisher Drops $925M Gatan Deal Under UK Pressure (Law360-$)
  • DOJ Can't Use 'Minimal' Probe To End FCA Suit, Judge Says (Law360-$)
  • Patent Owners Have One Less Adversary As Supreme Court Bars Government From Filing IPR Petitions (Pink Sheet-$)
  • “But For” Personal Jurisdiction (Drug & Device Law)
  • FDA unveils new guidelines for e-cigarette makers (Reuters) (FDA)
Upcoming Meetings & Events
  • FDA Advisory Committee Calendar
  • June 11-12, 2019: Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee – 11-12 June 2019
  • The Complex Web of Prescription Drug Prices, Part III: Examining Agency Efforts to Further Competition and Increase Affordability – 19 June 2019
  • Development of Best Practices in Physiologically Based Pharmacokinetic Modeling To Support Clinical Pharmacology Regulatory Decision-Making; Public Workshop – 18 November 2019
  • TrialChain: A Blockchain-Based Platform to Validate Data Integrity in Large, Biomedical Research Studies – 11 June 2019
  • Pharmacovigilance Risk Assessment Committee (PRAC) Draft Agenda (EMA)
  • Collaboration between France and WHO to Realize the Vision of the WHO Academy (WHO)
  • Drug shortages are endangering lives and wasting NHS time (The Guardian)
  • The Yellow Card Scheme: guidance for healthcare professionals, patients and the public (MHRA)
  • Marketing authorisations granted in May 2019 (MHRA)
  • Parallel import licenses granted in May 2019 (MHRA)
  • Asia Regulatory Roundup: China Tightens Genetic Material Rules, Places Extra Restrictions on Foreigners (Focus)
  • Indian pharma growth slips to single digit at 7% in May 2019 to Rs.11,244 crore (PharmaBiz)
  • Three workers killed by explosion at pharma factory in India (Pharmafile)
  • Health Canada Notice Details When Off-Label Use is not Considered Investigational in a Clinical Trial (Focus)
  • Quebec enforcement op targets counterfeit medicines (Securing Industry)
  • Update - Notice: Introduction of the Regulatory Enrolment Process (REP) and the Use of the Common Electronic Submission Gateway (CESG) for Medical Devices (Health Canada)
  • Ingredient name changes: a medicine ingredient by any other name… (TGA)
  • Using 'natural' claims when advertising to the public (TGA)
  • Therapeutic goods advertising: Ensuring 'natural' claims are not misleading (TGA)
  • Target processing timeframes for Compliance Verification (CV) GMP clearance applications (TGA)
General Health & Other Interesting Articles
  • The last pandemic was a ‘quiet killer.’ Ten years after swine flu, no one can predict the next one (STAT)
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.
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