Cytokinetics Inc., of South San Francisco, said it began enrolling the expansion phase of COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure). The double-blind, randomized, placebo-controlled, multicenter phase II trial is designed to assess the pharmacokinetics and tolerability of omecamtiv mecarbil oral dosing in patients with heart failure and left ventricular systolic dysfunction. Read More
Actavis plc, of Dublin, said the U.S. Court of Appeals for the Federal Circuit has reversed a lower court ruling that Actavis’ generic version of Shire plc’s (also of Dublin) Lialda (mesalamine extended-release tablets) infringes U.S. Patent No. 6,773,720 (the ‘720 Patent). Read More
Scientists from Stanford University have developed a nanosensor that could improve the detection of liver toxicity in preclinical drug testing. Liver toxicity is one major form of drug toxicity, which, in turn, is the most frequent reason that drugs either fail to win FDA approval or are withdrawn from market. Read More
Halozyme Therapeutics Inc., of San Diego, said the European Commission has approved the subcutaneous formulation of Mabthera (rituximab) from Basel, Switzerland-based Roche AG for treating patients with follicular lymphoma and diffuse large B-cell lymphoma. Read More
Advaxis Inc., of Princeton, N.J., announced a full exercise of the overallotment option granted to the underwriters to purchase an additional 612,000 shares of its common stock at a public offering price of $3 per share in connection with its previously announced underwritten public offering of 4.08 million shares of common stock, bringing the total gross proceeds from the offering to approximately $14.076 million, before deducting expenses. Read More
Scientists have come to a surprising conclusion about how Taxol works – one that might lead to the development of biomarkers that could predict which patients will benefit from the drug, and of better anti-mitotic agents. Read More
Syndax Pharmaceuticals Inc. filed for an initial public offering (IPO) Friday under the Jumpstart Our Business Startups Act of 2012. The oncology-focused biotech with an FDA breakthrough designation for its lead program, entinostat, plans to use proceeds from the Nasdaq offering to support trials of the therapeutic and a new drug application for its use in treating metastatic breast cancer. Read More
Mention the term “hereditary ataxia” and the first disease likely to come to mind is Friedreich’s ataxia, a rare, genetic disorder that has nabbed the attention of several companies. Read More
Top-line data suggested the randomized, double-blind, placebo-controlled phase II trial of Idera Pharmaceuticals Inc.’s lead candidate IMO-8400 met its primary endpoint, demonstrating the compound was safe and well tolerated in patients with moderate-to-severe plaque psoriasis. Read More
Briefing documents released ahead of the Endocrinologic and Metabolic Drugs Advisory Committee meeting Tuesday for Mannkind Corp.’s regulatory-plagued inhaled insulin candidate, Afrezza, indicate that executives of the Valencia, Calif.-based firm have their work cut out for them. Read More
