Swedish firm Active Biotech AB nearly doubled its cash position and brought on board a new investor in a SEK270 million (US$42.6 million) fundraising this week. Read More
Seeking to lift the veil on its approval process, the FDA released a draft five-year plan describing the steps it's taking to further develop and implement a structured benefit-risk assessment to be used in agency reviews of drugs and biologics. Read More
Privately held Immunomic Therapeutics Inc. (ITI) worked quietly for five years to advance its LAMP-vax technology, based on lysosomal associated membrane protein (LAMP), a ubiquitous glycoprotein found on 80 percent of the surface area of lysosomal membranes. Read More
• Cadence Pharmaceuticals Inc., of San Diego, inked a supply agreement with Laboratorios Grifols S.A. to develop, manufacture and supply commercial quantities of Ofirmev (acetaminophen) injection in flexible plastic bags. Read More
• ADMA Biologics Inc., of Hackensack, N.J., enrolled its first patient in a Phase III trial of RI-002, an immune globulin, for primary immune deficiency diseases (PIDD). The trial will enroll 60 to 70 patients for a 12-month treatment period followed by up to 90 days safety monitoring and follow-up. Its goal will be to evaluate safety and efficacy of the drug. Read More
• Kowa Co. Ltd., of Tokyo, and Eli Lilly and Co., of Indianapolis, reported results showing that Livalo (pitavastatin), after 12 weeks of therapy, had a significantly greater decrease in low-density lipoprotein cholesterol in HIV-infected adults with dyslipidemia, with and without viral hepatitis B or C, compared to pravastatin (-49.4 mg/dL and -33.6 mg/dL, respectively; p < 0.001). Read More
• Otsuka Pharmaceutical Co. Ltd., of Tokyo, and H. Lundbeck A/S, of Copenhagen, Denmark, said that Abilify Maintena (ariprazole), an extended-release (once-monthly) injectable suspension for schizophrenia will become available on the U.S. market on March 18, following its approval by the FDA on Feb. 28. Read More
