IN THE NEWS
Johnson & Johnson has spent $200 million on production of an Ebola vaccine that is set to begin human testing in the U.S., Europe and Africa in January, but talk of potential collaboration with GlaxoSmithKline remains only theoretical at this point.
Sponsors of clinical trials for new migraine therapies should focus on enrolling more women of childbearing age early in the drug development process, as more women than men have the condition, according to a new FDA draft guidance.
A coalition of drugmakers wants to boost performance at clinical trial sites by establishing common standards for good clinical practices and skill requirements for investigators.
Imnovid did not show superiority over either Revlimid or Velcade.
It can now be used to treat patients with mantle cell lymphoma.
The approval boosts the company’s already robust hepatitis C portfolio.
The FDA last week approved the company’s emergency investigational NDA.
A question-and-answer document released by the European Medicines Agency in September clarifies terms of engagement and expected outcomes for applicants to the agency’s adaptive licensing pilot program.
The company cited concerns of an insufficient target population.
Drug sponsors should find a more comprehensive way of recording and integrating patient outcomes data into their efficacy analyses, says a top FDA official who notes the lack of such data often presents a roadblock to making regulatory decisions.
Drugmaker Chimerix said it may soon start testing its broad-spectrum antiviral drug brincidofovir against the Ebola virus, after the FDA this week approved the company’s emergency investigational new drug application.
Companies developing pediatric vaccines for diphtheria, tetanus and pertussis, or DTaP, can streamline the process by using a single dosing schedule in clinical trials, new guidance from the European Medicines Agency says.
Sponsors submitting plans to test drug products in children in Europe need to provide the European Medicines Agency with information on all formulations being developed, according to final guidance published Sept. 27.
Indian authorities are reminding clinical investigators that trial applications must include information on the unmet medical need and risk-benefit assessments of the proposed drug, as well as comparisons of the innovator product and existing options.
The FDA has issued a preliminary list of 20 disease targets under an initiative to spur drugmakers to include patient perspectives earlier in the drug development process.
Bristol-Myers Squibb has withdrawn its NDA for a hepatitis C combination drug of Daclinza and asunaprevir, citing concerns of an insufficient target population.
Researchers determined efficacy data from Phase III trials weren’t strong enough to support a regulatory submission.
Drugmakers seeking accelerated approval of a presurgical treatment for high-risk, early-stage breast cancer may consider conducting multiple trials rather than a traditional single trial, according to a new FDA guidance that aims to give sponsors an earlier indication as to the success of a drug candidate.
The FDA has issued guidance on using social media for approved products, but the agency has been markedly silent on how drugmakers can use Facebook, Twitter and other platforms for drug development, an expert said.
Manufacturers that sell drugs in the European Union will soon have to make publicly available clinical trial data supporting approval of those products, under a landmark transparency policy adopted yesterday by the European Medicines Agency.
Eli Lilly has given up on its lupus drug candidate tabalumab after researchers determined the efficacy data from two Phase III studies were not strong enough to support a regulatory submission.
Drug sponsors submitting plans to test products in children in Europe need to provide the European Medicines Agency with information on all formulations they are developing, according to a finalized pediatric investigation plan that took effect this week.
Pharmaceutical companies developing new pediatric vaccines for diphtheria, tetanus and pertussis (DTaP) should conduct clinical trials using a single dosing schedule as a means to streamline the process, according to a new guidance from the European Medicines Agency.
Canada's Tekmira Pharmaceuticals received FDA clearance to provide its TKM-Ebola RNA interference therapeutic to patients with suspected or confirmed cases of the deadly disease.
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.
The therapy had failed a previous Phase III trial last fall.
Merck said it is giving up on its cancer treatment candidate tecemotide as a monotherapy for stage III non-small cell lung cancer.
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.
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.
The FDA has released an action plan aimed at encouraging more diverse patient participation in drug and medical device clinical trials.