Search Results for Antimicrobial Resistance

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Is Increasing Antibiotic Resistance Driving Bacteriophage Therapy Closer to Being a Reality? By Max Sherman - Published 14 August 2017

This article reviews the history of bacteriophage discovery, biology, and potential medical uses, and discusses therapeutic pros and cons compared to and potentially replacing antibiotics due to increasing antibiotic resistance. The article also highlights the future of phage therapy and the need for more scientific investigation and clinical trials prior to approval for human use and the possible patenting and regulatory issues impacting bacteriophage development. The US Food and Drug Administration (FDA) recently covered issues related to bacteriophage development during a workshop in July 2017.

Categories: Features, FDA, Biologics and biotechnology

Tags: Bacteriophage, Phage, Antimicrobial Resistance

FDA, EMA and PMDA Seek Antimicrobial Clinical Study Regulation Harmonization By Zachary Brennan - Published 26 May 2017

For the second time in seven months, the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) met in late April to discuss their approaches for evaluating antimicrobial agents, with the aim of identifying areas for convergence.

Categories: News, Asia, Europe, US, EMA, FDA, PMDA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: antimicrobial resistance, antibiotic resistance, new antibiotics

Asia Regulatory Roundup: Australia Scraps Target Date for Processing GMP Applications (25 April 2017) By Nick Paul Taylor - Published 25 April 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, MFDS, TGA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia regulatory roundup, GMP applications, stents, antimicrobial resistance

European Regulatory Roundup: UK Fines Pfizer for 2,600% Price Hike (8 December 2016) By Nick Paul Taylor - Published 08 December 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: European Regulatory Roundup, Pfizer, ATMP, GMP manufacturing, antimicrobial resistance

FDA, EMA, PMDA Begin Push for New Antibacterials By Michael Mezher - Published 08 September 2016

The US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) met at EMA headquarters in London last week to discuss their role in promoting the development of new antibacterial products.

Categories: News, Japan, Europe, US, EMA, FDA, PMDA, Clinical, Drugs, Preclinical, Regulatory strategy, Research and development

Tags: Antimicrobial resistance, AMR

FDA Finalizes Guidance on Microbiology Data for Antibacterials By Michael Mezher - Published 29 August 2016

The US Food and Drug Administration (FDA) on Friday finalized guidance intended to help drugmakers prepare the data necessary to support the approval of new antibacterial drugs.

Categories: News, US, FDA, Clinical, Drugs, Preclinical, Research and development

Tags: Antibacterial, Antimicrobial resistance, Microbiology data, Final guidance

Woodcock: Antibiotics Pipeline is 'Fragile and Weak' By Michael Mezher - Published 14 June 2016

At a congressional hearing in Washington, DC on Tuesday, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said that current incentives are not enough to overcome the challenges of developing new drugs to fight bacterial infections.

Categories: News, US, FDA, Clinical, Drugs, In vitro diagnostics, Preclinical, Research and development

Tags: Antimicrobial Resistance, AMR, Antibiotics, Janet Woodcock, Energy & Commerce Committee, GAIN Act, ADAPT Act

Experts Call for New Regulatory Pathways for Antibiotics By Michael Mezher - Published 15 December 2015

Faced with the increasing threat of antimicrobial resistance (AMR), experts are calling for more incentives to boost investment in new antibiotics.

Categories: News, US, FDA, Drugs, Regulatory strategy, Reimbursement

Tags: Antimicrobial Resistance, Reimbursement, Limited Population Antibacterial Drug, LPAD, Qualified Infectious Disease Product, QIDP

FDA Releases 18 Years of Isolate-Level Data for Common Gut Bacteria By Michael Mezher - Published 20 August 2015

In a move to make its data more transparent and promote scientific research, the US Food and Drug Administration (FDA) is releasing 18 years of data on several bacteria, collected as part of the National Antimicrobial Resistance Monitoring System (NARMS).

Categories: News, US, FDA, Drugs, Government affairs, Research and development

Tags: Antimicrobial resistance, AMR, Antibiotic resistance, NARMS

AmpliPhi Biosciences Gets First cGMP Certification for Bacteriophage Facility By Michael Mezher - Published 04 June 2015

AmpliPhi Biosciences announced Wednesday it has received the first ever good manufacturing practices certification for its bacteriophage facility in Slovenia.

Categories: News, Europe, Biologics and biotechnology, Manufacturing, Regulatory strategy, Research and development

Tags: Phage therapy, Bacteriophage, antimicrobial resistance, Good manufacturing practice, GMP

World Health Assembly Adopts Action Plan on Antimicrobial Resistance By Michael Mezher - Published 26 May 2015

In Geneva Monday, members of the World Health Assembly (WHA) endorsed a plan to fight antimicrobial resistance (AMR) on a global scale.

Categories: News, WHO, Advertising and Promotion, Distribution, Drugs, Labeling, Regulatory strategy, Research and development

Tags: Antimicrobial resistance, AMR, WHA68, World Health Assembly

To Fight Antimicrobial Resistance, FDA Asks Animal Drugmakers for More Information By Alexander Gaffney, RAC - Published 19 May 2015

A new regulation proposed by the US Food and Drug Administration (FDA) would require manufacturers and sponsors of veterinary antibiotics used in food-producing animals to collect and submit data regarding the use of the drugs in specific animal species.

Categories: News, US, CDER, Distribution, Drugs, Postmarket surveillance

Tags: AMR, Antimicrobial Resistance, NARMS, Regulation, Proposed Regulation, Antimicrobial Animal Drug Sales and Distribution Reporting

EU Parliament Calls for Measures to Combat Antimicrobial Resistance By Michael Mezher - Published 19 May 2015

The European Parliament is calling for new measures to combat antimicrobial resistance (AMR) in Europe, where 25,000 die each year due to drug-resistant infections.

Categories: News, Europe, EC, EMA, Drugs, Government affairs, Reimbursement, Research and development

Tags: Antimicrobial resistance, AMR, European Parliament

UK Review: New Models Needed to Fight Antimicrobial Resistance By Michael Mezher - Published 15 May 2015

A review of antimicrobial resistance (AMR), commissioned by the UK and led by internationally renowned economist Jim O'Neill, is calling for billions of dollars in new funding intended to incentivize drug development and head off the threat of drug-resistant disease.

Categories: News, Europe, Drugs, Regulatory strategy, Reimbursement, Research and development

Tags: Antimicrobial resistance, AMR, drug discovery, Jim O'Neill

Public Health Groups Propose Global Drug Innovation Fund By Michael Mezher - Published 13 May 2015

Two health advocacy groups, Médecins Sans Frontières (MSF) and the Drugs for Neglected Diseases initiative (DNDi) are urging public health authorities to create a global fund to tackle what they call "deadly gaps in innovation."

Categories: News, WHO, Biologics and biotechnology, Drugs, Research and development

Tags: Médecins Sans Frontières, MSF, Drugs for Neglected Diseases initiative, DNDi, Ebola, antimicrobial resistance, AMR, neglected tropical diseases, NTD

Global Efforts to Combat Antimicrobial Resistance 'Lacking,' WHO Report Finds By Michael Mezher - Published 29 April 2015

The World Health Organization (WHO) has completed the first global assessment of national strategies to counter the rise of antimicrobial resistance (AMR). Only a quarter to countries had plans in place to limit the use of antimicrobials, leaving "major gaps" in the struggle against AMR in every region of the world.

Categories: News, WHO, Drugs

Tags: WHO, Antimicrobial Resistance, Antibiotics, AMR

In Fight Against Antimicrobial Resistance, EMA Looks to Public for Help By Michael Mezher - Published 16 March 2015

The European Medicines Agency (EMA) is looking for feedback on a new set of principles for setting the defined daily dose (DDDA) and defined course dose (DCDA) for antimicrobial products used in animals.

Categories: Drugs, Postmarket surveillance, Veterinary products

Tags: Antimicrobial Resistance, AMR, European Surveillance of Veterinary Antimicrobial Consumption, ESVAC, defined daily dose, defined course dose

EU Considers Major Revisions to Veterinary Medicines Regulations By Michael Mezher - Published 13 March 2015

The European Parliament is considering major changes to how veterinary medical products are regulated in the EU.

Categories: Distribution, Postmarket surveillance, Submission and registration, Veterinary products

Tags: Veterinary Medicines, Environment Public health and Food Safety (ENVI), Antimicrobial Resistance

EMA Releases new Policies Meant to Combat Antimicrobial Resistance By Michael Mezher - Published 05 March 2015

As part of its efforts to combat antimicrobial resistance (AMR), the European Medicines Agency (EMA) has issued two draft guidelines related to the use of antimicrobial agents in veterinary medicinal products.

Categories: News, Europe, EMA, Drugs, Regulatory strategy, Veterinary products

Tags: Antimicrobial resistance, AMR, Veterinary

Three EU Agencies Collaborate on Drug Resistance Study By Michael Mezher - Published 30 January 2015

Three EU agencies have announced they will work together in the hopes of better understanding one of today's most pressing global healthcare issues: Antimicrobial resistance (AMR).

Categories: News, Europe, EC, EMA, Drugs

Tags: Antimicrobial Resistance, AMR

FDA Doubles Down on Voluntary Approach to Limiting Use of Antibiotics in Food-Producing Animals By Alexander Gaffney, RF News Editor - Published 11 December 2013

Categories: US, FDA

Tags: Antimicrobial Resistance, antibiotics

FDA, Others Plan Meeting to Address Antimicrobial Resistance By Alexander Gaffney - Published 19 September 2012

Categories: FDA

Tags: Antimicrobial Resistance, ITFAR, CDC, antibiotics, NIH, Meeting, Latest News