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IN THE NEWS


Executive Order Aims to Combat Antibiotic-Resistant Bacteria, Stoke Pipeline

A federal effort to spur the development of new drugs to treat antibiotic-resistant infections comes as the industry warns the antibiotics pipeline is running dangerously low and more financial incentives will be required to encourage development in this area.

Merck Halts Development of Lung Cancer Treatment

The therapy had failed a previous Phase III trial last fall.

EMA Q&A Guidance Provides Clarity on Adaptive Licensing Pilot Program

The European Medicines Agency wants to help manufacturers take advantage of its adaptive licensing pilot program, which aims to speed patient access to new treatments via a process that authorizes products for use by targeted populations in stages.

Merck Scraps Development of Lung Cancer Treatment

Merck said it is giving up on its cancer treatment candidate tecemotide as a monotherapy for stage III non-small cell lung cancer.

Proposal Could Shrink Time to Clinical Trials in Brazil

Drugmakers could see their wait time to begin clinical trials in Brazil cut by more than a third under a proposed regulation calling for protocols to be reviewed in their entirety, rather than in stages, as is the current policy.

FDA Action Plan Will Enhance Demographic Data in Trials

The FDA has released an action plan aimed at encouraging more diverse patient participation in drug and medical device clinical trials.

Exelixis’ Cabozantinib Fails in Prostate Cancer Trial

The drug is indicated for treating thyroid cancer.

FDA Removes Partial Clinical Hold on Trials for OncoMed’s Ipafricept

Drugmaker OncoMed expects to resume enrollment and dosing of new patients for its experimental cancer drug ipafricept in the coming weeks, after the FDA lifted a partial hold on its clinical trials.

J&J, NewLink Genetics Fast-Track Ebola Vaccine Trials

Johnson & Johnson and NewLink Genetics are the latest companies to seek Ebola treatments through accelerated human trials of vaccine candidates, an effort that is getting a boost from a collaboration of international regulatory agencies.

Exelixis Drops Cabozantinib in Prostate Cancer Trial

San Francisco-based drugmaker Exelixis is halting research into the use of its thyroid cancer therapy Cometriq for treating prostate cancer after the drug failed a Phase III trial for that indication.

FDA Lifts Partial Clinical Hold on Trials for OncoMed’s Vantictumab

Cancer drugmaker OncoMed expects to resume enrollment and dosing of new patients for its experimental oncology drug vantictumab within the next few weeks, after the FDA removed a partial clinical hold on its clinical trials.

Australia Considers Adoption of EU Drug Development Guidelines

The Therapeutic Goods Administration is looking to Europe for guidance on drug development, including clinical development of biosimilar drugs, investigations of lipid disorder therapies and evaluations of bacterial infections.

GSK, NIH Fast-Track Testing of Ebola Vaccine, Build Up Stock

GlaxoSmithKline and the National Institutes of Health say they are fast-tracking clinical trials of their experimental Ebola vaccine candidates, and that the drugmaker will make up to roughly 10,000 additional doses of the vaccine so that stocks can be made available immediately if results are positive.

Japan’s PMDA Clarifies Requirements for Companion Diagnostic PMAs

Companies filing premarket approval applications for companion diagnostics may explain the clinical significance and clinical cut-off of their products using a summary of the clinical results for the corresponding drug product, recent technical guidance from Japan’s Pharmaceuticals and Medical Devices Agency says.

FDA Proposes Changes to GST Regulations for Biologics Manufacturers

Certain general safety testing requirements may no longer be necessary to help ensure the safety, purity and potency of licensed biological products, the FDA said.

FDA Releases Action Plan to Encourage More Demographic Subgroup Trial Data

Pharmaceutical companies should boost their efforts to collect and analyze demographic subgroup data in clinical trials, including by ensuring studies have enough women, minorities and elderly patients to be consistent with disease prevalence, the FDA has suggested.

FDA Reduces Clinical Hold on Tekmira’s Experimental Ebola Drug

The FDA has downgraded its clinical hold on Tekmira Pharmaceuticals’ TKM-Ebola experimental RNA interference therapeutic, a move that could clear the way for the drug’s potential use in individuals infected with Ebola virus.

HHS Panel Discusses Pros/Cons of Big Data in Clinical Research

Must investigators obtain informed consent anew in order to use aggregated clinical trial data for secondary purposes? What purpose does this data serve to improve standards of care? And are there risks inherent in using such data?

Australian Details Requirements for Biopharmaceutic Studies

Sponsors registering new drugs or updating existing drugs on the Australian Register of Therapeutic Goods will need to conduct biopharmaceutic studies and generate specific data on test results, the Therapeutic Goods Administration says.

Japan Clarifies Requirements for Companion Diagnostics

Companies filing premarket approval applications for companion diagnostics may explain the clinical significance and clinical cut-off of their products using a summary of the clinical results for the corresponding drug product, recent technical guidance from Japan’s Pharmaceuticals and Medical Devices Agency says.

HHS Panel: Sites Should Provide Trial Results to Patients

Sites should state clearly what patients can expect regarding access to personal results from clinical trials in their informed consent documents, an expert witness told the Secretary’s Advisory Committee on Human Research Protections in Rockville, Md., on July 22.

FDA Updates Informed Consent Guideline to Ensure Participation Is Voluntary

Sponsors designing clinical trials that involve certain vulnerable patient populations will soon face greater scrutiny from institutional review boards, under newly issued FDA guidance.

Master Clinical Trial Protocols Enable New Antibacterial Drug Development

Conducting clinical trials with multiple drug candidates from different manufacturers simultaneously will be key.

Ebola Vaccine Trials Set to Start Next Month

The National Institutes of Health is talking with drugmakers about the potential of scaling up production of an experimental recombinant Ebola vaccine set to enter human testing next month.

EMA Seeks Guidance on Developing Genomic Biomarkers

The European Medicines Agency is seeking suggestions on promising techniques to identify genomic biomarkers that might spur development of targeted therapies.

Master Clinical Trial Protocols Offer Path to Developing New Antibacterial Drugs

Conducting clinical trials with multiple drug candidates from different manufacturers simultaneously will be key to developing new antibacterial therapies, experts seeking to address the growing problem of antibiotic resistance say.

EU Approves Alcon's Simbrinza Eye Drops

Drops are for the treatment of glaucoma.

EMA Issues Guidance on Development of Flu Vaccines

Developers of influenza vaccines in Europe will have to conduct additional postmarket effectiveness studies and expand their criteria for evaluating immune responses of products in the clinical testing phase, according to the European Medicines Agency.

FDA Considers Letting Branded Drugmakers Reserve Names

Goal is to curb potential delays at time of drug approval.

Application for First Malaria Vaccine Submitted to EMA

GSK developed the product in partnership with PATH Malaria Vaccine Initiative and Bill & Melinda Gates Foundation.