Regulatory Focus™ > News Articles > Regulatory Recon: New Batch of Drugs Recommended by EMA (27 February 2015)

Regulatory Recon: New Batch of Drugs Recommended by EMA (27 February 2015)

Posted 27 February 2015 | By Alexander Gaffney, RAC

Regulatory Recon: New Batch of Drugs Recommended by EMA (27 February 2015)

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

In Focus: US

  • Where's FDA's past-due 'animal rule' final guidance? (SCRIP-$)
  • FDA Releases Biannual Progress Report on Judicious Use of Antimicrobials in Food-producing Animals (FDA) (Farm Futures)
  • FDA AdComm to Discuss The Medicines Company's NDA for Cangrelor (FDA)
  • FDA Rebuffed on Quality Culture, Right-First-Time Metrics (Gold Sheet-$)
  • Actavis Avycaz Approval Shows How FDA Handles Limited-Data, Limited-Use Antibiotic (Pink Sheet-$)
  • FDA Approves Allergan’s Natrelle Inspira Round Gel-Filled Breast Implants (Press)
  • Actavis' contraceptive device wins U.S. FDA approval (Reuters)

In Focus: International

  • EMA's CHMP Recommends Three New Medicines for Approval (EMA)
  • Antimicrobial Resistance to remain a priority in the EU beyond 2016 (EC) (ECDC)
  • Sparring Begins Over a European Policy for Disclosing Clinical Trial Data (Pharmalot)
  • Adjusted fees for applications to European Medicines Agency from 1 April 2015 (EMA)
  • Japan hits Novartis with 15-day ban over side effect reports (PharmaTimes) (Fierce)
  • India taking further steps to reform clinical trial industry (Outsourcing Pharma)
  • Academics urge updating WHO, ICH guidelines to ensure quality drugs used in clinical trials (Outsourcing Pharma)

As the EU Gears up for Major Device Changes, What do Regulatory Pros Need to Know?

  • In Europe, medical devices currently are regulated much the same way they have been since the 1990s. Now, almost 20 years and several major scandals later, EU officials are preparing a massive overhaul of the region's medical device regulatory directives in the hopes of modernizing the system—if only they could agree on what those changes should look like. (Regulatory Focus)
  • Find out what changes are likely to affect medical devices and IVDs next year in this 11 March 2015 webcast featuring expert Erik Vollebregt. (RAPS Webcast)

US: Pharmaceuticals and Biotechnology

  • Where's FDA's past-due 'animal rule' final guidance? (SCRIP-$)
  • FDA Releases Biannual Progress Report on Judicious Use of Antimicrobials in Food-producing Animals (FDA) (Farm Futures)
  • FDA AdComm to Discuss The Medicines Company's NDA for Cangrelor (FDA)
  • FDA Rebuffed on Quality Culture, Right-First-Time Metrics (Gold Sheet-$)
  • Actavis Avycaz Approval Shows How FDA Handles Limited-Data, Limited-Use Antibiotic (Pink Sheet-$)
  • Opposing Views Muddy Outlook for FDA’s Quality Metrics Initiative (Gold Sheet-$)
  • No Leg to Stand On: Sandoz Takes on Amgen’s Bid for an Injunction in Filgrastim Biosimilar Litigation (FDA Law Blog)
  • OGD’s January Productivity Stats are In – What Do We See? (Lachman)
  • San Francisco Moves Closer to a Take-Back Program (Pharmalot)
  • Public Citizen Blasts FDA for Delaying Generic Drug Labeling Rule (Public Citizen)
  • Federal Charges Filed Against New Jersey Compounding Pharmacy (AP)
  • Biopharma Looks Into The Supply Chain Mirror: We're The Problem (LifeSciLeader)
  • FDA’s Blizzard of Enforcement at Compounding Pharmacies Evident in GMP Warning Letters for FY 2014 (Gold Sheet-$)
  • J&J Units Look To Ditch Sunscreen SPF Labeling Claims (Law 360-$)

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

  • BMS and Gilead antivirals cure hep C in co-infected HIV patients (PMLIve) (Reuters) (AP) (Press) (SCRIP-$) (Press)
  • Biogen Idec and Sobi Announce Positive Top-Line Efficacy and Safety Results from Phase 3 ALPROLIX Pediatric Study (Press)
  • Novartis Amends Heart-Drug Trial (WSJ-$)
  • Gilead Announces Phase 3 Results for Investigational Once-Daily Single Tablet HIV Regimen Containing Tenofovir Alafenamide (TAF) (Press)
  • AMG 416 non-inferior to Sensipar, but Amgen's regulatory strategy undetermined (SCRIP-$)
  • Valeant touts PhII Provenge data following Dendreon buy (Fierce)
  • Boehringer puts BACE inhibitor trial on hold (PharmaTimes) (BioCentury)

US: Pharmaceuticals and Biotechnology: General

  • Panel: Use New Meningitis Vaccines Only for Outbreaks  (AP) (Fierce) (Reuters)
  • Advisory Committee on Immunization Practices (ACIP) reaffirms recommendation for annual influenza vaccination (CDC)
  • Merck’s 9-Valent HPV Vaccine, GARDASIL 9, Recommended by CDC’s Advisory Committee on Immunization Practices for Females Aged 9-26 and Males Aged 9-21 (Press)
  • The Drug Pipeline Flows Again—at a Cost (Bloomberg)
  • Medical countermeasures drive pharma innovation: US officials (SCRIP-$)
  • Gilead Avoids Billions in U.S. Taxes on Its $1,000-a-Pill Drug (Bloomberg)
  • 5 prescription drugs most likely to be abused – and leave you in the ER or worse (Iodine)

US: Medical Devices

  • FDA Approves Allergan’s Natrelle Inspira Round Gel-Filled Breast Implants (Press)
  • Actavis' contraceptive device wins U.S. FDA approval (Reuters)
  • Boston Scientific launches upgraded endoscope, says it will reduce repeat procedures (Fierce) (MedGadget) (Mass Device)
  • How 23andMe used rigorous clinical trials to win a landmark FDA authorization  (BioPharmaDive)
  • DexCom profitable for the first time, completes FDA submission for smartphone glucose monitor (Fierce)
  • Master Data Management Is Crucial for Medical Device Makers (MDDI)
  • BioFire Diagnostics Receives FDA Clearance for FilmArray 2.0 System (GenomeWeb)

US: Dietary Supplements

  • A Tale Of Two Expectations: NDI Notification Estimate And Guidance (Tan Sheet-$)
  • Harkin Passes Torch to Heinrich on Dietary Supplement Issues (NPI)

US: Assorted And Government

  • The 2015 Office of Regulatory Science and Innovation Science Symposium (FDA)
  • Savings From a Single Food Safety Agency Appeal to Some House Republicans (FSN)
  • PCORI explains how it will release comparative-effectiveness findings (MM&M)

Upcoming Meetings

Ebola Outbreak

  • Decision on Ebola mass vaccination in August at earliest: WHO (Reuters)
  • Liberia-U.S. clinical research partnership opens trial to test Ebola treatments (NIH)
  • ZMapp Ebola Trial To Start ‘Any Day’ With New FDA/NIH Protocol (Pink Sheet-$)

Europe

  • EMA's CHMP Recommends Three New Medicines for Approval (EMA)
  • Antimicrobial Resistance to remain a priority in the EU beyond 2016 (EC) (ECDC)
  • Sparring Begins Over a European Policy for Disclosing Clinical Trial Data (Pharmalot)
  • Adjusted fees for applications to European Medicines Agency from 1 April 2015 (EMA)
  • Novartis' Zykadia recommended for approval in advanced non small cell lung cancer (EMA) (Reuters)
  • EU agency recommends approval of Otsuka kidney drug Jinarc (Reuters) (EMA)
  • Sanofi diabetes drug Toujeo wins European green light (Reuters) (Press)
  • After painful odyssey, Newron wins European OK for Parkinson's add-on (Fierce) (Press) (SCRIP-$)
  • Ambroxol and bromhexine expectorants: safety information to be updated (EMA)
  • Alexion Receives CHMP Positive Opinions for Important Updates to the EU Label for Soliris (Press)
  • Companies need to wake up to compliance: worrying trends and uncomfortable reading (Clinica-$)
  • EC Authorizes Durata's Zydalba (EC)
  • EC Authorizes Teva's Clopidogrel (EC)
  • AMR review head O'Neill calls for $2 billion innovation fund (PharmaTimes)
  • EMA will review Amgen/Onyx' myeloma drug (PharmaTimes) (Press)
  • NICE wants more research on Sobi's Xiapex (SCRIP-$)
  • Chiesi found to have breached ABPI Code (PharmaLetter-$)
  • Meridian Bioscience Gets CE Mark for CT/NG Tests, Sample Prep System (Genome Web)
  • EU Trade Secrets Directive Threatens Scientific Open Data (ComputerWorldUK)
  • A new strategy for Ph. Eur. General Methods: Ph.Eur. Commission established a new Working Party (EDQM)
  • Public consultation of the draft methodological guideline “Process of information retrieval for systematic reviews and health technology assessments on clinical effectiveness” (EUnetHTA)

India

  • India taking further steps to reform clinical trial industry (Outsourcing Pharma)
  • NPPA to discuss identification marks for drugs under ceiling price with trade, BDCDA wants red color on packs (PharmaBiz)
  • DRL gets final hearing from State FDA minister in a case related to violation of D&C Act (PharmaBiz)

Japan

Canada

  • Health Canada Approves Jinarc for ADPKD (Press)
  • Novo Nordisk receives Health Canada approval for Saxenda® (liraglutide) for the treatment of chronic weight management (Press)

Other International

  • Academics urge updating WHO, ICH guidelines to ensure quality drugs used in clinical trials (Outsourcing Pharma)

Clinical Trials

  • Why Clinical Trialists Fail to Publish Completed RCTs (TIE)

General Regulatory And Interesting Articles

  • Building An Affordable 3D-Printed Arm (Digg)
  • Cat allergy treatment could net billions for UK pharma Circassia (Guardian)
  • Nasal flu vaccines may be safe for kids with egg allergies (Reuters)

Regulatory Reconnaissance #503 – 27 February 2015

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 @AlecGaffney 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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