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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• The last pandemic was a ‘quiet killer.’ Ten years after swine flu, no one can predict the next one (STAT)