Regulatory Focus™ > News Articles > Regulatory Recon: Juno to Resume Cancer Immunotherapy Trial; FDA Expands Label for Pfizer Pneumonia

Regulatory Recon: Juno to Resume Cancer Immunotherapy Trial FDA Expands Label for Pfizer Pneumonia Vaccine (13 July 2016)

Posted 13 July 2016 | By Michael Mezher 

Regulatory Recon: Juno to Resume Cancer Immunotherapy Trial FDA Expands Label for Pfizer Pneumonia Vaccine (13 July 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Anti-trust regulators want more on Abbott's pending, $25B St. Jude Medical buyout (MassDevice)
  • FDA Takes Action against Zika Virus (FDA Voice)
  • FDA Panel Unanimously Backs Amgen's Humira Biosimilar (Focus)(Reuters)
  • Juno to Resume Clinical Trial of Anticancer Treatment (WSJ-$) (Reuters) (Press)
  • FDA Plans to Use Public Genetic Variant Databases for NGS Test Regulation But Not Many May Qualify (GenomeWeb)
  • Foods and Veterinary Medicine Program's Strategic Plan for Fiscal Years 2016-2025 (FDA)
  • Researchers: Patient Reported Outcomes for Heart Failure Fail to Meet FDA Criteria (Focus)
  • Amgen and Hospira Square Off Over BPCIA Private Right of Action After Amgen v. Apotex Ruling (Biologics Blog)
  • FDA to Drug Compounders: Inspection Changes Coming in August (Focus)
  • Winning Combination: How Technology And Skills Are Taking Up The Fight Against Cancer (Forbes)
  • FDA expands use of Pfizer's best-selling pneumonia vaccine (Reuters) (Press)
  • FDA: New Generic Labeling Guide Doesn't Signal Policy For Broader Rule (InsideHealthPolicy)
  • What lies ahead for FDA regulation of tDCS products? (Journal of Law and the Biosciences)
  • Collins talks gene editing at final consensus study meeting (BioCentury)
  • The one that got away: Obamacare and the drug industry (Politico)
  • Senate Pushes Work on 'Cures' Legislation Back to September (Focus) (Energy and Commerce)
  • HHS Report Says Obamacare Plans Are Cheaper Than They Look (NPR)
  • Senate Expected To Pass Broad Bill To Address Opioid Epidemic (NPR)

In Focus: International

  • GE aims for $1 billion cell therapy 'tools' business with Swiss deal (Reuters)
  • Sepsis is just as urgent as heart attack, says NICE (NICE)
  • ICH S9 Q&As reaches Step 2b of the ICH Process (ICH)
  • Asia Regulatory Roundup: CFDA Looks to Resolve Vaccine Shortages (Focus)
  • CDSCO to Assume Sponsors are Abandoning Applications if They do not Submit Requested Information Within 45 Days (CDSCO)
  • Dr Reddy's recalls 9,330 bottles of Sirolimus tablets in US (Economic Times)
  • Brexit Rewrites Script for Device Manufacturers with Business in Europe (AAMI)
  • Generic Drugs From Four Indian and Chinese Companies Blocked From Entering US (Focus)
  • A Communist Has Sparked a Cheap-Medicine Frenzy All Across Chile (Bloomberg)
  • Sanofi Sees Cure for Cancer Woes in Moving West for Acquisitions (Bloomberg)
  • Teva Raises Guidance (WSJ-$)
  • UN ramps-up HIV, hepatitis C fight, inks pact with Aurobindo Pharma, Emcure, Lupin,others (Financial Express)
  • AIDS conference returns to a changed South Africa (Reuters)

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US: Pharmaceuticals & Biotechnology

  • Lilly and Boehringer team up for experimental breast cancer trial pact (Fierce) (Press)
  • Merck: Vaccine manufacturers must innovate or get left behind (BioPharmaReporter)
  • Researchers make advance in possible treatments for Gaucher, Parkinson's diseases (NIH)
  • Monthly Round-Up of What to Read on Pharma Law and Policy (Harvard Bill of Health)
  • OPINION: Stop Pharma Hopping Mischief (Law360-$)
  • Pricing Stress may Weigh on Generic Drugmakers Ahead of Q2 Earnings (The Street)
  • Today's pharma leaders are less experienced in other sectors, but does it matter? (PharmaLetter)
  • Evotec licenses CRISPR gene editing tech (BioPharmaReporter)
  • Don't deny HIV patents lymphoma treatment, say US researchers (BioPharmaReporter)
  • Bacterial Vaginosis: Developing Drugs for Treatment; Draft Guidance for Industry (FDA)
  • Stem Cells To Make Hair Today-Gone Tomorrow A Thing Of The Past (Forbes)
  • Skin cancer risk for freckly red-heads equivalent to 21 years in sun (Reuters)
  • Unrealistic expectations may hinder blood cancer patients' care (Reuters)
  • Pluristem poised for US cell therapy trial after contracting CRO (BioPharmaReporter)
  • Escitalopram does not improve outcomes for depressed patients with heart failure (Pharmaceutical Journal-$)
  • Pharma's digital health ambitions: Where are the opportunities and what's hindering progress? (MedCityNews)
  • ​How Harvard Biosciences grapples with the blessing and curse of its own name (Boston Biz Journal)

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

  • 2016/17 Formulation of Flublok® Influenza Vaccine Receives FDA Approval (Press)
  • AbbVie's ABT-414 Gets Rare Pediatric Disease Status in U.S. (Yahoo Finance)
  • Pfizer Announces the Publication of Final Results from Two Pivotal Phase 3 Studies of Crisaborole Topical Ointment in Patients with Mild to Moderate Atopic Dermatitis (Press)
  • Takeda Announces FDA Approval of Dexilant (dexlansoprazole) for Patients 12-17 Years of Age (Press)
  • Inotek Pharmaceuticals Initiates Phase 2 Dose-ranging Trial of a Fixed-Dose Combination of Trabodenoson, a Novel Treatment for Glaucoma, and Latanoprost (Press)
  • Mitralign Completes Enrollment in First Phase of US Early Feasibility Study on Tricuspid Repair (Press)
  • TARIS Biomedical Initiates Phase 1b Clinical Trial of TAR-200 (GemRIS) in Patients with Muscle-Invasive Bladder Cancer (Press)
  • St. Renatus, LLC Announces FDA Approval of KOVANAZE (tetracaine HCl and oxymetazoline HCl) Nasal Spray for Use in Dentistry (Press)

US: Medical Devices

  • Why I disagree with the snake oil analogy (MassDevice)
  • Alere withdraws INRatio monitors from US market (MassDevice)
  • Here's how the pause in the medical device tax has been a boon (MedCityNews)
  • Analytica gets over-the-counter FDA clearance for smartphone-connected pelvic floor muscle trainer (MobiHealthNews)
  • District Court Opinion Provides Guidance for Extensions of Medical Device Patents Containing Method Claims (Inside Medical Devices)
  • Medical Devices; Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures (FDA)
  • INRatio and INRatio2 PT/INR Monitor System by Alere: Recall - Potentially Inaccurate INR Results (FDA)
  • Medtronic Receives FDA Approval for IN.PACT Admiral DCB 150 mm Lengths (Press)
  • Cartiva, Inc. Announces First US Procedure for FDA Approved Cartiva Synthetic Cartilage Implant (Press)
  • SinuSys Corp. Receives FDA Clearance for the Vent-Os Sinus Dilation Family of Devices (Press)

US: Assorted & Government

  • The Latest DOJ Setback - Jury Acquits Former Warner Chilcott Senior Executive (Policy and Medicine)
  • FDA Proposes Additional Scientific Data to Support the Safety and Effectiveness of Certain Active Ingredients for Use in Topical Consumer Antiseptic Rubs (FDA Law Blog)
  • The 2016 Medicare Trustees Report: Is Medicare Doomed? (Health Affairs Blog)
  • Surgical technician pleads guilty to drug tampering in Colorado (Economic Times)

Upcoming Meetings & Events

Europe

  • New £80m treatments fund will offer hope to patients with life-threatening conditions (Wales Online) (ABPI)
  • What's Next for the European Economic Area (EEA) Qualified Person for Pharmacovigilance (QPPV) Working in the UK? (Bioclinica)
  • UK Infected blood payment scheme reformed (DoH)
  • Marketing authorisations granted in June 2016 (MHRA)
  • Parallel import licences granted in June 2016 (MHRA)

Asia

  • JP Frequently Asked Questions (PMDA)
  • Sri Lanka encourages Indian pharma companies to set up units in the country (BioSpectrum)

India

  • Sun Pharma appoints Abhay Gandhi CEO of North American business (Economic Times)
  • Sun Pharma brings back old hand Kalyanasundaram Subramanian from Taro Pharmaceutical (Economic Times)
  • Government's new draft rules could improve quality of medical devices for patients (Economic Times)

Australia

  • Quickie Q7 manual wheelchair (TGA)

Canada

  • Dear Health Care Professional Letter – DARZALEX (Health Canada)

Other International

  • Sky-high bills leave Nigerian mothers and newborns trapped in hospitals (Reuters)

General Health and Other Interesting Articles

  • Adolescent birth rate drops across all racial groups, annual report shows (NIH)

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.


Categories: Recon, Regulatory News

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