The Burrill Report
China's Ministry of Public security has arrested at least 30 employees of GlaxoSmithKline, including some senior executives, for alleged bribery and tax violations. GSK says that recent details released by the ministry provided its first official insight into the matter and that the company had not detected bribery through its own internal monitoring. Formal charges will not be filed against GSK's employees until Chinese officials complete their preliminary investigations, according to Reuters. If evidence is found supporting China’s allegations, GSK could face legal trouble not just in China, but also in the United Kingdom and United States, both of which have laws forbidding bribery of foreign officials.
An independent data and safety monitoring board recommended that Roche halt a late-stage trial of aleglitazar for the management of patients with increased risk of heart disease and type 2 diabetes. The undisclosed concerns are related to safety and lack of efficacy. Roche will work with investigators to assist in managing patient transition from aleglitazar treatment to other blood sugar control therapies. The company will also terminate all other trials involving aleglitazar, a small molecule activator of both alpha and gamma forms of the peroxisome proliferator-activated receptor whose dual function was under investigation to improve both insulin sensitivity and defective lipid metabolism.
A federal court jury began hearing evidence in a trial accusing CR Bard of making its Avaulta Plus vaginal mesh from plastic unsuitable for human implantation and of hiding that information from doctors and women. The claims in the case include accusations that CR Bard ignored a warning from Chevron Phillips Chemical, maker of the mesh-implant’s plastic, that indicated the material shouldn’t be used in “medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.” There are at least 3,600 claims over the implant citing organ damage and painful sexual intercourse from the device as it erodes. Last year CR Bard pulled the implants off the market after the U.S. Food and Drug Administration ordered all makers of mesh vaginal implants to analyze organ damage, infection, and painful sex linked to their products.
Aveo Pharmaceuticals received a subpoena from the U.S. Securities and Exchange Commission requesting documents and information related to tivozanib, its oral, investigational tyrosine kinase inhibitor in clinical trials for cancer. The U.S. Food and Drug Administration wants communications with their own agency, investors, and others, and Aveo has said it will cooperate fully. The agency’s Oncologic Drugs Advisory Committee recommended against approving tivozanib for the treatment of advanced renal cell carcinoma in May but the compound is still in trials for breast and colorectal cancer. Tivozanib is a non-selective inhibitor of all three vascular endothelial growth factor receptors.
India’s Department of Industrial Policy and Promotion has halted U.S.-based Mylan's planned $1.6 billion purchase of Agila Specialties, a division of Bangalore-based Strides Arcolab that handles injectables. The Foreign Investment Promotion Board deferred a decision on the deal over concerns that it would transfer the vaccine plant to a foreign owner, that foreign multinational firms are taking over the few remaining domestic cancer drug-making facilities, and that the purchase would limit the country's ability to supply affordable medicines to its citizens. With the U.S. market facing acute shortages of many injectables, especially cancer therapies in the past few years, companies manufacturing these drugs have become lucrative targets for multinationals, according to the Economic Times.
July 12, 2013