The FDA’s Antiviral Drugs Advisory Committee voted 15 – 0 to recommend approval of Gilead Sciences Inc.’s sofosbuvir for genotype 2 and 3 hepatitis C virus (HCV) patients and for treatment-naïve genotype 1 and 4 patients. Read More
Dynavax Technologies Corp. gained financial traction for the continued traversal of its long road with hepatitis B virus (HBV) vaccine Heplisav, pulling down about $132 million in a pair of public offerings that will fund another, FDA-mandated Phase III trial. Read More
LONDON – Actelion Ltd. added the European Medicines Agency’s (EMA) nod for Opsumit (macitentan) in treating pulmonary arterial hypertension (PAH) to FDA approval received at the end of last week. (See BioWorld Today, Oct. 21, 2013.) Read More
Not if, but when and how. That’s the conclusion most biopharmaceutical executives have today when it comes to developing a global strategy – increasingly focused on Asia. China likely will be the second-largest pharmaceutical market by 2020, surpassing Japan. Surrounding countries such as Taiwan and South Korea already have powerful biotechnology and biosimilars subsectors well established. To succeed in today’s global economy, an Asia strategy is not optional. Read More
By first looking at the tumor of one specific lung cancer patient in prodigious detail, and validating their findings a large number of cell lines, researchers have achieved two things. Read More
• Bioheart Inc., of Sunrise, Fla., said it entered an agreement with Anosis, a company based in Turkey, to distribute their therapies in Turkey, Azerbajian, Kazakhistan, Turkmenistan, Georgia and Iraq. Terms were not disclosed. Read More
• Immunogen Inc., of Waltham, Mass., reported a net loss of $11.2 million, or 13 cents per basic and diluted share during its 2014 first quarter ending Sept. 30, compared to a net loss of $25.2 million, or 30 cents per basic and diluted share, for the same quarter in the previous year. Revenues for the quarter were $17.2 million, compared to $4.1 million during the same quarter a year earlier, and included $13.2 million in license and milestone fees compared to $900,000 in the same quarter a year earlier. Read More
• Santarus Inc., of San Diego, said based on data from its Phase I study testing SAN-300, an antibody designed to inhibit very late antigen-1, the firm will initiate a placebo-controlled, multiple-ascending-dose Phase IIa trial with subcutaneous administration in patients with active rheumatoid arthritis. The study is slated to start this quarter. Read More
• H. Lundbeck A/S, of Valby, Denmark, said the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion and recommended marketing authorization for Brintellix (vortioxetine) to treat adults with major depressive episodes, or depression. Read More
Scientists from Johns Hopkins University have shown that erasing HIV’s reservoir may prove more challenging than anticipated. The reservoir consists of infected T cells that are not dividing and so are immune to antiviral medications. In cell culture, most such T cells do not release functional HIV even when they are stimulated to divide, and scientists have assumed that is due to the integrated virus having defects that prevent it from being able to replicate. Read More
