Regulatory Recon: FDA Panel Denies Support for Abuse-deterrent Opioid (11 September 2015)

Posted 11 September 2015 | By Zachary Brennan 

Regulatory Recon: FDA Panel Denies Support for Abuse-deterrent Opioid (11 September 2015)

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

  •  US FDA Advisory Committee Nearly Unanimously Withholds Support to Approve Purdue’s Avridi (Reuters) (SAC Tracker)
  • Congress Will Not Tinker With FDA LDT Guidance Before Final, Staffers Indicate (Gray Sheet-$)
  • Calif. Lawmakers Approve Bill Requiring Drug Labeling In 5 Foreign Languages (Kaiser Health News)
  • Is FDA Having Trouble Setting Date for Biomarin, Sarepta Advisory Panels? (TheStreet)
  • Clinical Oncologists: Next Generation Sequencing Needs Uniform Reg Plan (InsideHealthPolicy-$)

In Focus: International

  • UK's Latest Cancer Drug Cull Draws Renewed Calls For NICE Reform (Pink Sheet-$)
  • UK's MHRA takes action against NW Bio for advertising an unlicensed medicine (MHRA)
  • EC Calls for Indefinite Exemption from Pharma IP Rules for Least-Developed Countries (Focus) (PharmaLetter-$)

US: Pharmaceuticals and Biotechnology

  • Actelion in talks with ZS Pharma amid surge in biotech deal-making (Reuters)
  • AstraZeneca Purchases US Biologics Manufacturing Facility to Support Growing Pipeline (Press)
  • Pfizer Made ‘Groundless Threats’ to Pharmacies in Patent Dispute (Bloomberg)
  • Landmark UK patent case rules against Pfizer (PharmaTimes)(Reuters)
  • Radio on GSK's latest setback, Kyle Bass' 'truthful irrelevancy,' and Horizon's web presence (FierceBiotech)
  • CardioBrief: When Should Drugs Be Discontinued? (MedPage Today)
  • Doubleplusgood CorporateSpeak (In the Pipeline)
  • SSR report links PBM exclusions to cresting drug prices (BioCentury)
  • Spark Tries to Quell Investor Fears About Gene Therapy Test (TheStreet)
  • Eli Lilly expands size of new Kendall Square innovation center (Boston Business Journal)
  • Allergan Settles With Amneal Pharmaceuticals over Namenda XR ANDA (FDANews-$)
  • East Coast Biotech Roundup: Biogen, Watson, Data Dumps & More (Xconomy)

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

  • Merck KGaA to try again to get approval for MS pill cladribine (Reuters)(FierceBiotech)(SCRIP-$)
  • Aridis Pharmaceuticals Receives FDA Fast Track Designation for AR-301 for Acute Pneumonia caused by Staphylococcus aureus (Press)
  • Allergan And Perrigo Receive FDA Approval Of Three Extended Release Products Equivalent To Mucinex And Mucinex DM (Press)
  • AstraZeneca to present data from its diabetes portfolio and pre-clinical research at EASD 2015 (Press)
  • NIH panel approves Sangamo hemophilia B protocol (BioCentury)
  • US FDA accepts first digital medicine application (Focus)(Pharmafile)

US: Medical Devices

  • New device could save millions from septic shock (Reuters)
  • FDA Approves First Touchscreen Insulin Pump With CGM Integration (Med Device Online)
  • Velico Medical extends BARDA contract (Mass Device)
  • Delphinus raises nearly $40m for SoftVue breast ultrasound (Mass Device)
  • How the FDA process is biased against new technology (MobiHealthNews)
  • ShiftLab's first device is nearing commercialization. Will it start a low-cost revolution? (FierceMedicalDevices)
  • Booz Allen On Track To Deliver CDRH Progress Report To Congress In February (Gray Sheet-$)
  • 3M mulls HIT spinout or sale (Mass Device)
  • Cardiac Dimensions touts cost-utility study of Carillon mitral valve (Mass Device)

US: Assorted and Government

  • New FDA Rules Tighten Food Safety Requirements (WSJ)
  • Bernie Sanders unveils bill to battle rising drug prices (FiercePharma)
  • King & Spalding Lures Off-Label Expert From FDA (Law360-$)
  • Senators Reintroduce Bill to Stop Pay-For-Delay Drug Deals (Focus)(FDANews-$)
  • Senate ‘Innovation’ Bill Being Narrowed With Year-End Committee Passage In Mind (Pink Sheet-$)
  • FDA Focus: Suing the FDA (PharmaLetter-$)
  • Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implications (Federal Register)
  • Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Federal Register)
  • Invokana and Invokamet (canagliflozin): Drug Safety Communication (FDA)(Law360-$)
  • Medistat RX Sterile Drug Products: Recall - Possible Contamination (FDA)
  • The Amarin Injunction (PhillyCooke Consulting)

Upcoming Meetings and Events              

Europe

  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 September 2015 (EMA)
  • La Jolla Pharmaceutical Company Receives Positive Opinion from European Orphan Committee for LJPC-401 (Press)
  • NICE nod for BI's lung-scarring drug Ofev (PharmaTimes)
  • Europe pledges greater access to medication (Digital Journal)
  • EU celebrates 50 years of pharmaceutical legislation (Manufacturing Chemist)
  • EDQM revised policy document “Content of the Dossier for Chemical Purity and Microbiological Quality" (EDQM)
  • Janssen seeks EU marketing nod for daratumumab to treat relapsed, refractory multiple myeloma (PharmaBiz)
  • MedImmune, Cancer Research UK Open Cancer Biotherapeutics Lab (GEN)
  • Big-name backers give ReViral $21M to move RSV drug into the clinic (FierceBiotech)
  • Boston Scientific wins CE Mark for Vercise DBS component (Mass Device)
  • Euro Biotech Report (FierceBiotech)

Australia

  • National guideline for retail storage of Schedule 6 and Schedule 7 poisons (TGA)

India

  • Tuberculosis an 'economic drain', impediment to development: Ratan Tata (Economic Times)

China

  • Mindray management lowers takeover offer to $3B (Mass Device)

Ebola Outbreak

  • IMF says it's committed to backing Liberia’s recovery from Ebola (Reuters)
  • New cheaper, sensitive Ebola test to help curb disease spread (Economic Times)

General Health and Other Interesting Articles

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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe