Janssen Pharmaceuticals Inc., of Titusville, N.J., part of Johnson & Johnson, said a study in the April 2015 issue of The Journal of Clinical Psychiatry showed long-acting Invega Sustenna (paliperidone palmitate) was effective six months longer than other oral antipsychotics commonly prescribed for schizophrenia, and delayed relapses, which can result in hospitalization, arrest and incarceration. Read More
The EMA released two draft good practice guides to improve the reporting, evaluation and prevention of medication errors by regulators and drugmakers. Read More
Daiichi Sankyo Co. Ltd., of Tokyo, said Swissmedic, the regulatory authority of Switzerland, approved Lixiana (edoxaban), an oral, once-daily selective factor Xa inhibitor, to prevent stroke and systemic embolism in adults with nonvalvular atrial fibrillation. Read More
Heart Metabolics Ltd., of Dublin, received an agreement letter from the FDA related to the company's proposed phase III trial special protocol assessment, agreeing to a single, randomized, pivotal trial of 350 patients evaluating perhexiline for the treatment of moderate-to-severe hypertrophic cardiomyopathy. Read More
Celprogen Inc., of Torrance, Calif., said it developed a pharmacological inhibitor, CEP1430, a synthetic molecule capable of inhibiting the growth and proliferation of the human pancreatic tumor. Read More
Biodel Inc., of Danbury, Conn., said it priced a public offering of 32.6 million shares of common stock at 92 cents per share and granted underwriters an option to purchase up to 4.9 million shares to cover overallotments. Read More
Researchers at the University of California at Berkeley have developed the prototype of a better mousetrap for in vitro drug studies that could someday transform the screening of cardiovascular drug candidates. The ultimate goal is to replace the use of animals to screen drug candidates for safety and efficacy, reducing both the time and cost to speed therapies through the development pipeline. Read More
The FDA's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 9-2, with one abstention, Wednesday to recommend approval for The Medicines Co.'s (MDCO) cangrelor, but the panel's love for the drug wasn't much lovelier the second time around. Read More
PARIS – In Europe, patient involvement in drug development and regulatory assessment is evolving from an ad hoc occurrence into a more structured process, driven by a shared interest on the part of regulators and drug developers in having patient input influence the development and assessment process. Read More
The results of a new study call into question the practice of sequencing patient's tumors without directly comparing the sequence data to the individual patient's healthy genome. Read More
It might not add much to Pfizer Inc.'s bottom line, since oral Ibrance (palbociclib) is approved already as a first-line therapy, but the first randomized phase III data with the compound made a strong showing in the trial called PALOMA-3, stopped early because of solid efficacy. Read More
Shares of Aduro Biotech Inc. (NASDAQ:ADRO) rose 147 percent to $42 in the company's Nasdaq debut Wednesday as investors clamored to get a piece of the cancer immunotherapy company's upsized 7 million share offering. Read More
