IN THE NEWS
The new labeling will reflect increased risks of death for patients with ventilator-associated pneumonia.
After six years of uncertainty, the FDA has lifted a clinical hold on trials of Oxygen Biotherapeutics’ Oxycyte intravenous emulsion, reviving hope for the drugmaker’s traumatic brain injury treatment.
Eisai and Biogen Idec have signed an agreement to develop and commercialize multiple potential treatments for Alzheimer’s disease.
AbbVie’s hepatitis C candidate showed positive results in the Phase III Pearl-III study, the drugmaker said.
The UK’s NICE has asked Alexion Pharmaceuticals for more information on the pricing of Soliris.
House lawmaker proposes a repeal of the orphan drug tax credit upsetting industry supporters.
When drugmakers change analytical validation methods during a drug’s lifecycle, the FDA says they should archive product samples to permit comparative studies of the old and new validation methods.
Study results from InterMune’s lung drug puts candidate back in play after FDA rejection in 2010.
FDA advisors reject anti-blood clotting drug, The Medicines Company CEO still hopeful for FDA approval.
Actavis plans to buy Forest Labs in a $25 billion deal that would expand the company’s reach into the primary care market and add to its pipeline in a wide range of diseases.
Bayer’s recombinant factor VIII met its primary endpoints in a Phase II/III trial of hemophilia A patients.
New data collection methods show more trials than previously thought need to meet their postmarketing requirements (PMR) and postmarketing commitments (PMC), a new FDA report says.
In another blow to Aveo’s oncology pipeline, Astellas announced it is ending a global partnership with the company to develop its troubled cancer drug tivozanib by August 11.
Regeneron touted its position in the international anti-VEGF market in an investor call Tuesday.
The European Medicines Agency is encouraging drugmakers looking to apply novel drug development tools to first seek the agency’s blessing and get qualification or prospective advice.
Videotapes of patients giving informed consent to participate in clinical trials must show the investigator explaining the study protocol in language the subject can understand, according to a draft guideline by India’s Central Drugs Standard Control Organization.
Japanese officials launched an investigation Jan. 10 into claims that falsified clinical trial data were used in an Alzheimer’s study involving several major drugmakers, marking an expansion of the country’s scrutiny of trial data misuse.
The European Medicines Agency is following in step with U.S. regulators and, at the request of Sweden’s medicines authority, is reviewing the efficacy of emergency contraceptives in heavier women.
Sprout Pharmaceuticals will resubmit its flibanserin NDA later this year after an FDA request for two more Phase I trials.
Sponsors of both over-the-counter and prescription point-of-care blood glucose tests should design trials that replicate real-world usage conditions, the FDA says.
Johnson & Johnson unveiled a first-of-kind clinical trial data-sharing plan that it hopes will become a model for industry transparency initiatives: rather than provide direct access to trial data, sponsors could contract with third parties to serve as gatekeeper and approve data access requests.
The FDA’s breakthrough therapy program is proving its potential to advance new drugs and biologics targeting unmet needs, a new Tufts University report says. But industry interest in the year-old program may wane if the approval times for breakthrough drugs don’t improve.
Drugmakers are encouraged to work together to get agency qualification for drug development tools, which can be used to aid in development and review of multiple companies’ drugs, according to an FDA final guidance.
CHMP adopted MCP-Mod as an efficient statistical has model for dose-finding studies under model uncertainty.
Companies producing vaccines in the EU to protect against annual flu strains will not need to conduct pre-approval clinical trials to support vaccine applications beginning with the 2015/2016 flu season.
Shire said Thursday it will abandon the development of its blockbuster hyperactivity drug Vyvanse as a treatment for major depressive disorder after two failed Phase III trials.
A new report released by Evaluate Pharma predicts that 2014 may be a disappointing year for pharma companies’ R&D productivity.
To help the European Medicines Agency (EMA) meet 90-day deadlines for orphan drug designation reviews, the agency is asking sponsors to give two months’ advance notice of their intent to file.
Merck & Amgen will collaborate on a Phase Ib/II trial evaluating Merck’s MK-3475 in combination with Amgen’s talimogene laherparepvec anti-cancer immunotherapies.
Merck and Ablynx have signed an agreement that will further their collaboration in the area of nanobodies, this time to target tumors’ immune-coopting mechanisms.