A month ago, Tekmira shares took a deep dive after the FDA placed a clinical hold on its Ebola therapy, the RNAi therapy TKM-Ebola, citing concerns about cytokine release--a condition which can spur a fatal noninfectious fever in the worst cases. The Canadian biotech's shot up more than 12% on Monday morning on speculation that the FDA would put the treatment back on its fast track.
Pfizer and Roche are the latest pharma heavyweights to join Icon's consortium of drugmakers working to flesh out new technology for adaptive clinical trials, allowing study sponsors to react to results in real time and maximize efficacy.
Amgen put out the word Monday morning that Kyprolis--provided in a combo package with Celgene's Revlimid--beat out Revlimid alone in a head-to-head Phase III study for multiple myeloma, hitting the primary endpoint and offering the Big Biotech a shot at expanding its franchise for the drug at a critical moment in the company's history.
Austria-based vaccinemaker Affiris announced that its Parkinson's disease vaccine has met its primary endpoint in a small Phase I safety trial of patients receiving two different doses of the jab.
The technology going into the device, called Rapid Evaporative Ionization Mass Spectrometry, by the Waters Corporation, is a move that one of the developers hopes will give the project new momentum.
Well-heeled venture capital firm Venrock has pieced together a 7th fund, banking $450 million in new investments as it sets out to grow its portfolio of promising startups.
Most devices are launched in Europe before arriving in the U.S., and cardiology devices are certainly no exception to the rule. Tough FDA premarket review standards, and the novelty of the technology, have turned the race to sell the first bioresorbable stent in the U.S. into a marathon.
Oraya Therapeutics, the developer of a low energy X-ray beam that can safely deliver radiation therapy to the into the eye, is expanding its presence in Europe. The 20-minute one-time procedure is designed to reduce the need for anti-vascular endothelial growth factor injections in patients with wet age-related macular degeneration.
Sanofi and Regeneron are heading to the FDA with a potential blockbuster cardiovascular treatment, touting positive results from a slew of Phase III trials in which the drug slashed patients' bad cholesterol.
Researchers have found a way to use nanoparticles to deliver drugs that can "wake up" the immune system and fortify its natural response to harmful cancer cells in the body.