Drug Development Pharma - November 24, 2014
CHMP Approves Victoza
The Committee for Medicinal Products for Human Use (CHMP) today issued a positive opinion for the use of Victoza® (liraglutide) in adults with type 2 diabetes and moderate renal impairment. Once the European Commission approves the label expansion, physicians in the European Union will be able to prescribe Victoza®, a once-daily human glucagon-like peptide-1 (GLP-1) analogue, to […]
Drug Development Pharma - November 21, 2014
Joint Bionor, FDA Study Possible
Norwegian company Bionor Pharma is in talks with the U.S. Federal Drug Administration (FDA) about a possible collaboration on a study to test a trial HIV vaccine early next year. Bionor reported strong results in one of its tests of vaccine Vacc-4x in combination with the drug Revlimid. Vacc-4x works by activating the body’s immune system to kill […]
Drug Development Pharma - November 20, 2014
BerGenBio Drug Gets Orphan-Drug Status
BerGenBio AS, a Norwegian oncology biopharmaceutical company, announced Wednesday that the US Food and Drug Administration (FDA) granted orphan-drug designation for BGB324 for treatment of acute myeloid leukemia (AML). Earlier this month BerGenBio announced that the first patient was dosed in its multi-center Phase 1b trial of BGB324, a selective inhibitor of Axl, in patients […]
Drug Development Pharma - November 19, 2014
AstraZeneca Officials Optimistic
AstraZeneca officials are feeling positive about the future, with enough drugs in production to fuel double-digit submissions and approvals by 2017, reaffirming its promise to grow sales by 75 percent. The company has 14 Phase III drugs that will account for eight-to-ten approvals over the next two years. Leading the way is the company’s revitalized […]
Drug Development Pharma - November 14, 2014
AZ Developing Blood-Thinner Antidote
While sales of AstraZeneca’s blood-thinner Brilinta have been growing, the company has started a preclinical development program on a potential Brilinta antidote, now known as MEDI2452. If it works, the antidote could quickly reverse the effects of the blood thinner in an emergency, such as a person having a major bleeding episode. Doctors would not […]
Drug Development Pharma - November 14, 2014
New Dengue Vaccine Sought
Norwegian researchers are hoping to develop a plant-based vaccine for dengue fever, an often deadly disease on the rise in Asia. As was the case with the ZMapp Ebola medicine, the scientists are utilizing tobacco plants to develop antibodies. Developing new vaccines often is extremely costly and time-consuming, so researchers are eager to find easier […]