IN THE NEWS
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.
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?
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.
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.
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.
Sponsors designing clinical trials that involve certain vulnerable patient populations will soon face greater scrutiny from institutional review boards, under newly issued FDA guidance.
Conducting clinical trials with multiple drug candidates from different manufacturers simultaneously will be key.
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.
The European Medicines Agency is seeking suggestions on promising techniques to identify genomic biomarkers that might spur development of targeted therapies.
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.
Drops are for the treatment of glaucoma.
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.
Goal is to curb potential delays at time of drug approval.
GSK developed the product in partnership with PATH Malaria Vaccine Initiative and Bill & Melinda Gates Foundation.
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.
The European Medicines Agency has approved a controversial policy that grants researchers access to detailed clinical trial data submitted in support of drug approvals.
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.
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.
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.
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.
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.
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.
The FDA is making minor changes to its recommendations for sponsors developing new treatments for all types of uncomplicated gonorrhea.
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.
Bills introduced in four states would grant terminally ill patients access to post-Phase-I experimental drugs without having to go through the FDA.
Company stops a Phase III Trial of nivolumab after showing superior survival compared to chemo.
The company said it plans to apply for FDA and European approval in the fourth quarter.
Company says there is no longer an unmet need for its treatment, faldaprevir.
Federal and state lawmakers are questioning whether the FDA’s Expanded Access program, which allows terminally ill patients to use experimental drugs in certain cases, adequately addresses the current need, with several states considering legislation that would let patients bypass the agency in acquiring investigational therapies.
Each year, up to 20 percent of the U.S. population gets the flu, resulting in more than 200,000 flu-related hospitalizations and 36,000 deaths.