Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves New Shingles Vaccine; NICE Oks Gene Therapy for Rare Condition (23 Oc

Regulatory Recon: FDA Approves New Shingles Vaccine NICE Oks Gene Therapy for Rare Condition (23 October 2017)

Posted 23 October 2017 | By Zachary Brennan 

Regulatory Recon: FDA Approves New Shingles Vaccine NICE Oks Gene Therapy for Rare Condition (23 October 2017)

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

In Focus: US  

  • FDA approves a new vaccine for shingles that provides broad protection ( Stat) ( Reuters)
  • Will FDA Add Suffixes to Approved Biologics' Names? ( Focus)
  • Gilead Science’s executive chairman talks about the new era of biomedicine and why drugs cost so much ( Wall Street Journal-$)
  • Drug Makers Find ‘Branded Generics’ Are a Source for Growth ( WSJ-$)
  • Layoffs ahead for nearly 300 as J&J winds down Animas ( Mass Device)
  • FDA To Name First Eight EU Member State Inspection Partners Under MRA ( Pink Sheet-$)
  • Effort to improve tracking of medical devices divides industry, consumer groups ( Minneapolis Star-Tribune)
  • Gottlieb: 50 Critical Devices At Risk Of Shortage Due To Hurricanes, FDA Eyes Importation ( InsideHealthPolicy-$) ( FDA)
  • White House Considering Bipartisan Drug Price Task Force ( Roll Call) ( Biocentury-$)
  • California judge tosses $417 million talc cancer verdict against Johnson & Johnson ( Reuters)

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In Focus: International 

  • NICE approves gene therapy for rare ‘bubble baby syndrome’ ( NICE) ( Pharmaphorum)
  • AstraZeneca among backers as Swiss cancer biotech raises $200 million ( Reuters)
  • WHO director-general rescinds Robert Mugabe’s appointment as ‘ambassador’ post ( Stat) ( WHO)
  • U.K. antitrust regulator opens new probes into generic drug competition ( Stat-$)
  • UCLA’s effort to patent a costly prostate cancer drug in India hurts the poor, critics say ( LA Times)
  • Japan Introduction of GDP Likely to Begin with Guideline that Calls on Companies to Make “Good Faith Effort”: MHLW Study Group ( Pharma Japan-$)
  • EMA, European Commission Look to Foster Development of Advanced Therapies ( Focus)
  • First Implementing Act Under EU MDR, IVDR Open for Consultation ( Focus)
  • One step closer to implementing the new MedTech Europe Code: Over ten organisations certified under the Ethical Charter ( MedTech Europe)
  • Don't ask GPs for antibiotics, new health campaign urges ( Guardian)

Pharmaceuticals & Biotechnology

  • Biosimilar Cost Savings in the United States ( RAND)
  • Bad Cells. So Many Bad Cells. ( In the Pipeline)
  • Eyeing an IPO, ADC Therapeutics fuels pivotal cancer trials with a $200M mega-round backed by AstraZeneca ( Endpoints)
  • Vantage Point – Pricing battle shifts to states ( EP Vantage)
  • Some state Medicaid programs continue to restrict access to hepatitis C drugs ( Stat-$)
  • New rules would curb payments to doctors from drug companies (
  • Healthcare earnings calls this week ( Brad Loncar Blog)
  • Google, Gates-backed Arsanis eyes $58M IPO ( Fierce)
  • ICER Week in Review ( ICER)
  • Lilly announces $72 million investment in diabetes manufacturing in Indianapolis ( Press)
  • Improving immuno-oncology with electronics-inspired gene 'circuits' ( Fierce)
  • Recipharm updates Lisbon plant ( InPharma)
  • Merck Sharp & Dohme B.V. v. Warner Chilcott Co. (Fed. Cir. 2017) ( Patent Docs)
  • SCA Pharmaceuticals Issues Voluntary Nationwide Recall of Specific Products Due to Potential Contamination ( FDA)
  • Boehringer Sues Drugmakers To Block Generic Gilotrif Plans ( Law360-$)

Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • DBV’s peanut problems open the door for Aimmune ( EP Vantage)
  • Novartis gets FDA breakthrough status for Tafinlar, Mekinist combination ( Reuters) ( Endpoints)
  • Microbiome merger flies Finch into late-phase R&D ( Fierce)
  • AstraZeneca and Merck Rapidly Advance olaparib in Japan With a Second Regulatory Submission ( Press)
  • Biogen and Eisai Expand Existing Collaboration Agreement to Develop and Commercialize Investigational Alzheimer’s Disease Treatments Including Phase 3 Aducanumab ( Press)
  • Trial watch: Tracing investment in drug development for Alzheimer disease ( Nature Reviews Drug Discovery)
  • Richard Lehman’s journal review—23 October 2017 ( BMJ)
  • Electronic Study Data Submission; Data Standards; Support for Version Update of WHO Drug Global ( Federal Register)
  • Anti-APRIL Antibody BION-1301 for Multiple Myeloma ( Cancer Biology blog)
  • Many Breast Cancer Patients Receive More Radiation Therapy Than Needed ( NPR)
  • HPV Vaccine Not Linked to Serious Complications in Adult Women ( Cancer Network)

Medical Devices

  • Smith & Nephew puts $210m on the table for Rotation Medical ( Mass Device)
  • Surmodics goes head-to-head with Medtronic’s drug-coated balloon in pivotal trial ( Mass Device)
  • New interoperability standards drive improvements in the management of patient care devices ( MedTech Intelligence)
  • Misonix inks $11m Chinese licensing, manufacturing deal for SonaStar ( Mass Device)
  • FDA Medical Devices; Immunology and Microbiology Devices; Classification of the Mass Spectrometer System for Clinical Use for the Identification of Microorganisms ( Federal Register)
  • FDA Medical Devices; Immunology and Microbiology Devices; Classification of the Zinc Transporter 8 Autoantibody Immunological Test System ( Federal Register)
  • Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Measure Non-Microbial Analyte(s) in Human Clinical Specimens To Aid in Assessment of Patients With Suspected Sepsis ( Federal Register)
  • New Device FDA Approval: Medtronic’s HeartWare ( FDA)
  • First Patient Treated in Landmark Transcatheter Mitral Valve Replacement (TMVR) Pivotal Trial ( Press)

US: Assorted & Government

  • FDA Releases 2015 NARMS Integrated Report With CDC and USDA ( FDA)
  • FDA denies Trang Doan Nguyen's request for a hearing and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Nguyen for 5 years ( Federal Register)
  • Watson Laboratories, Inc., and Barr Laboratories, Inc., Subsidiaries of Teva Pharmaceuticals USA, Inc.; Withdrawal of Approval of 54 Abbreviated New Drug Applications ( Federal Register)
  • FDA Will Decide If These 26 Ingredients Count As Fiber ( NPR)
  • Bringing the World Closer to Revised Measurement System, Scientists Update Four Key Fundamental Constants ( NIST)
  • Is the FDA keeping up with digital health disruption? ( PharmaLetter-$)
  • Sharpless sworn in as 15th NCI director ( Cancer Letter)

Upcoming Meetings & Events

General Health & Other Interesting Articles

  • A baby with a disease gene or no baby at all: Genetic testing of embryos creates an ethical morass ( Stat)
  • WHO promptly responds to Marburg Outbreak in Eastern Uganda ( WHO)
  • China Shuts Down Tens Of Thousands Of Factories In Unprecedented Pollution Crackdown ( NPR)
  • Drug court – giving families a chance to break the cycle of opioid use ( Guardian)

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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