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IN THE NEWS


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 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 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 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.

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.

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.

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.

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.

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?

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.

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.

EMA’s Clinical Trial Data Policy to Become Effective in the Fall

The European Medicines Agency has approved a controversial policy that grants researchers access to detailed clinical trial data submitted in support of drug approvals.

FDA Mulls Program to Let Drugmakers Reserve Proprietary Name

The FDA is considering letting branded drugmakers reserve a proprietary name for a new product, with the goal of avoiding potential delays by approving permanent drug names well in advance of product launch.

GSK Submits Application to EMA for First Malaria Vaccine

British drug giant GlaxoSmithKline has submitted the world’s first application for approval of a malaria vaccine, a product developed in partnership with the Bill & Melinda Gates Foundation and the PATH Malaria Vaccine Initiative.

FDA Aims to Minimize Potential for Coercion in Updated Clinical Trial Informed Consent Requirements

Sponsors designing trials involving certain vulnerable patient populations such as limited or non-English speakers, dementia or traumatic brain injury sufferers and children will soon face greater scrutiny from institutional review boards under newly issued FDA guidance.

Lilly and BI Insulin Biosimilar Wins Positive CHMP Recommendation

A key European panel has recommended approval for Eli Lilly and Boehringer Ingelheim’s biosimilar of Sanofi’s blockbuster long-acting insulin drug Lantus, creating a potential threat to the French drugmaker’s multi-billion dollar product.

Expert: How to Know When a Trial Is Applicable to clinicaltrials.gov

Not all clinical trials need to be registered on clinicaltrials.gov, so sponsors need to understand the specific elements that determine if their trial is applicable to those reporting requirements, an expert says.

Panel: No Need for Cardiovascular Trials for Opioid Constipation

Makers of drugs to treat opioid-induced constipation need not conduct further large, long-term cardiovascular outcomes safety trials, an FDA advisory panel tenuously concluded June 12, noting that it may be wiser to require postmarket observational studies.

FDA Revises Uncomplicated Gonorrhea Draft Guidance

The FDA is making minor changes to its recommendations for sponsors developing new treatments for all types of uncomplicated gonorrhea.

Duchenne Community Submits First-Ever Patient-Initiated Draft Guidance to FDA

A coalition of muscular dystrophy advocates, researchers, clinicians and drug manufacturers has submitted the first-ever patient-initiated draft guidance on drug development to the FDA, a move prompted by the agency’s efforts to get more patient perspectives into the drug approval process.