Regulatory Focus™ > News Articles > Regulatory Recon: EMA Releases Antibiotic Use Plan (1 August 2014)

Regulatory Recon: EMA Releases Antibiotic Use Plan (1 August 2014)

Posted 01 August 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: EMA Releases Antibiotic Use Plan (1 August 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register by 29 August 2014 to receive the lowest rate.

In Focus: US

  • Boehringer’s Striverdi gains FDA approval (Pharmafile) (FDA) (SCRIP-$) (MNT) (BioCentury) (Fierce) (Press) (Reuters)
  • U.S. FDA Noticed Data Tampering At Ipca’s Ratlam Unit, Expert Says (PharmAsia-$)
  • Individual Patient Expanded Access: Developing Principles For A Structural And Regulatory Framework (Health Affairs)
  • Why Crucial Vaccines Are Sometimes Unavailable (The Upshot)
  • Where’s The Bolus? ANDA Projections For FY 2015 Don’t Reflect Past, Future Surges (Pink Sheet-$)
  • US Patient Receiving Experimental Ebola Treatment (Daily Beast) (NBC) (CBS)
  • FDA panel green-lights Baxter and Halozyme's drug HyQvia on a second pass (Fierce) (BioCentury) (Reuters) (Press)
  • Johnson & Johnson Praised for Taking Uterine Surgery Tools Off Market (NYTimes)
  • FDA advisory panel to consider PMA of TissuGlu surgical adhesive (Fierce)

In Focus: International

  • EMA Releases Draft Antibiotic Use Policy (EMA) (Report)
  • European Medicines Agency invites comments on new overarching guidance for the development of influenza vaccines (EMA) (Guideline)
  • UK Politicians Call for Eventual Ban on Animal Testing (Pharma Times) (Pharmafile)
  • Vertex Receives European Approval for KALYDECO™ (ivacaftor) in Eight Non-G551D Gating Mutations (Press)
  • EMA publishes first public summaries of Paediatric Committee evaluations of paediatric investigation plans (EMA)
  • Vittamed wins 2 CE Marks for non-invasive neuro-diagnostics (Mass Device) (Press)
  • Rein in use of antibiotics in animals: Indian Medical Association (India Times)
  • Japanese regulators announce enforcement date for new medical device and drug laws (Emergo)

US: Pharmaceuticals and Biotechnology

  • Boehringer’s Striverdi gains FDA approval (Pharmafile) (FDA) (SCRIP-$) (MNT) (BioCentury) (Fierce) (Press) (Reuters)
  • U.S. FDA Noticed Data Tampering At Ipca’s Ratlam Unit, Expert Says (PharmAsia-$)
  • Individual Patient Expanded Access: Developing Principles For A Structural And Regulatory Framework (Health Affairs)
  • Why Crucial Vaccines Are Sometimes Unavailable (The Upshot)
  • Where’s The Bolus? ANDA Projections For FY 2015 Don’t Reflect Past, Future Surges (Pink Sheet-$)
  • Where are the Treatments for Ebola? (Guardian)
  • US Patient Receiving Experimental Ebola Treatment (Daily Beast) (NBC) (CBS)
  • FDA panel green-lights Baxter and Halozyme's drug HyQvia on a second pass (Fierce) (BioCentury) (Reuters) (Press)
  • Drugs you take while pregnant may not be as safe as you think (Consumer Reports)
  • Partnerships key for antibiotics' future: NIH-FDA forum (SCRIP-$)
  • FDA extends review for AZ's olaparib (BioCentury)
  • Muscular dystrophy biotechs buoyed by FDA's encouragement on accelerated Oks (Fierce)
  • Hovione’s Cork, Ireland API Plant Passes FDA Pre- Approval Inspection (PharmPro)

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

  • Sanofi sees first dengue vaccine filings in first quarter of 2015 (Reuters)
  • GSK and Genmab announce positive interim results for ofatumumab Phase III (Pharma Letter-$) (Press)
  • Taiho discontinues Phase III HCC trial (BioCentury)
  • Biota's flu drug fails mid-stage study (Reuters)
  • Study Casts Doubts on Truvada PReP for AIDS, Shows 49% Efficacy (Press)
  • Arzerra meets PFS endpoint as CLL maintenance therapy (BioCentury)
  • Development of Ebola vaccine placed on fast track amid West African outbreak (WaPo) (USA Today)
  • Sustained efficacy, immunogenicity, and safety for GlaxoSmithKline's HPV vaccine (Press)

US: Pharmaceuticals and Biotechnology: General

  • U.S. top lawyer calls for greater transparency over execution drugs (Reuters)
  • Illinois Med Director on Gilead Hep C Pill: “We Want to be Compassionate” (Pharmalot)

US: Medical Devices

  • Johnson & Johnson Praised for Taking Uterine Surgery Tools Off Market (NYTimes)
  • FDA advisory panel to consider PMA of TissuGlu surgical adhesive (Fierce)
  • FDA panel votes against Edap's ultrasound prostate cancer ablation (Mass Device) (Fierce)
  • HeartWare celebrates record Q2 sales despite regulatory pushback (Fierce)
  • Medicrea’s K-JAWS Obtains FDA Approval for Its Marketing in the United States (Press)

US: Assorted And Government

  • Bipartisan Committee Leaders Call on GAO to Evaluate Federal Lab Procedures Following Safety Lapses (E&C) (Letter) (The Hill)
  • New Bill Would Increase NIH Funding, Citing its Role in FDA Approvals (Bill)
  • Permanent R&D tax credit bill introduced in Senate (BioCentury)

Europe

  • EMA Releases Draft Antibiotic Use Policy (EMA) (Report)
  • European Medicines Agency invites comments on new overarching guidance for the development of influenza vaccines (EMA) (Guideline)
  • UK Politicians Call for Eventual Ban on Animal Testing (Pharma Times) (Pharmafile)
  • Vertex Receives European Approval for KALYDECO™ (ivacaftor) in Eight Non-G551D Gating Mutations (Press)
  • European Medicines Agency publishes first public summaries of Paediatric Committee evaluations of paediatric investigation plans (EMA)
  • European Commission Grants Orphan Drug Designation to Soliris (eculizumab) for the Treatment of Patients with Myasthenia Gravis (Press)
  • Vittamed wins 2 CE Marks for non-invasive neuro-diagnostics (Mass Device) (Press)
  • Revision of EDQM “Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia monographs” (EDQM)
  • Draft reflection paper on the use of cocrystals and other solid state forms of active substances in medicinal products (EMA)
  • Concept paper on revision of guideline on epidemiological data on blood transmissible infections (EMA)
  • Questions and answers on wheat starch containing gluten in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (EMA)
  • Draft guideline on core SmPC and package leaflet for sodium fluoride (18F) (EMA)
  • pSivida Corp. Reports ILUVIEN for Chronic Diabetic Macular Edema Receives Marketing Authorization in Denmark, 9th EU Approval (Press)
  • UK says hidden drugs shortage ‘getting worse’ as generics supply slows (In-Pharma)
  • Germany to set up eHealth council to promote healthcare technology (PMLive)
  • Politically acceptable - a unified patent for Europe (PMLive)

India

  • Indian Regulator Says New Legislation Not Needed for CDSCO to Regulate Medical Devices (PharmaBiz)
  • Rein in use of antibiotics in animals: Indian Medical Association (India Times)

China

  • 24 Pharma Companies Obtain New GMP Certification (PharmAsia-$)

Japan

  • Japanese regulators announce enforcement date for new medical device and drug laws (Emergo)

Canada

  • Health Canada Releases Canadian Adverse Reaction newsletter (Press)

Australia

  • New tool helps work out whether a product is a therapeutic good or food (TGA)

Clinical Trials

  • Five Ways To Improve Combination Studies Of Cancer Drugs (PAM-$)
  • Infographic: What is ClinicalTrials.gov? (Eli Lilly)

General Regulatory And Interesting Articles

  • Report: Medtech M&A exits don't hinge on FDA approval (Mass Device)
  • The Pill linked to breast cancer risk for younger women (Reuters)
  • Whooping cough vaccine safe for pregnant women (Reuters)
  • C. difficile vaccine proves safe, 100 percent effective in animal models (Press)

Regulatory Reconnaissance #370 – 1 August 2014

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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