P53 is a regulatory protein well known to cancer researchers and biotech firms alike. It is mutated in more than half of all human cancers. Even where it is not outright mutated, its functions appear compromised in most cancers. And some research has indicated that loss of p53 can turn cells into cancer stem cells. (See BioWorld Today, Sept. 21, 2009.) Read More
WASHINGTON – Threats of terrorist attacks in the wake of the death of Osama bin Laden and the reality of immense natural disasters are creating a sense of urgency as government officials recognize that the U.S. is "woefully behind" in its capability to rapidly produce vaccines and develop medical countermeasures (MCM). Read More
Tibotec Pharmaceuticals Inc.of Raritan, N.J., a unit of Centocor Ortho Biotech Inc., said the FDA approved Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in treatment-naïve patients. Edurant is a non-nucleoside reverse transcriptase inhibitor. The drug also is part of the single-tablet regimen combining it with Truvada (emtricitabine/tenofovir disoproxil fumarate) from Foster City, Calif.-based Gilead Sciences Inc. Dubbed "Btripla," the combo pill received a refuse-to-file letter for its new drug application in January, with requests for additional chemistry, manufacturing and controls information. Gilead resubmitted the application a few weeks later. Read More
Onyx Pharmaceuticals Inc., of Emeryville, Calif., reported updated results from the Phase IIb 003-A1 study of single-agent carfilzomib for treatment of patients with relapsed and refractory multiple myeloma in which carfilzomib achieved a clinical benefit rate (minimal response or greater) in the study population of 37 percent with a duration of response of 8.3 months. The primary endpoint, overall response rate (defined as partial response or greater) was 24 percent with a median duration of response of 7.8 months. Read More
The notion of a bad gut feeling is, apparently, literal: McMaster University scientists have shown that bacteria residing in the gut influence brain chemistry and behavior. Read More
About two weeks after AstraZeneca plc passed on an option for TC-5619, Targacept Inc. priced a $75 million public offering to move forward with the alpha7 neuronic nicotinic receptor-targeting drug on its own, with plans to launch a Phase IIb study in cognitive dysfunction in schizophrenia (CDS). Read More
Despite having a healthy amount of cash in its coffers, ImmunoGen Inc. capitalized on the fact that its stock is heading toward a 10-year high and raised $84 million in a public offering. Read More
