Ranbaxy, Daiichi Sankyo restructure board of directors
GURGAON, India Ranbaxy Labs and Daiichi Sankyo have reconstituted Ranbaxy’s board of directors, the two companies announced Friday.
Ranbaxy approved the reconstitution at a meeting at its headquarters in Gurgaon, India. The new composition of the board reflects Ranbaxy’s new ownership structure, following its November takeover by Daiichi Sankyo, which now owns 63.92 percent of India’s largest drug maker.
Ranbaxy CEO Malvinder Mohan Singh will become Ranbaxy’s chairman of the board, while Daiichi Sankyo president and chief executive officer Takashi Shoda will also join the board. Ranbaxy will remain a publicly listed company and continue operating as an independent and autonomous entity.
AstraZeneca seeks approval for use of Nexium in infants
NEW YORK AstraZeneca has submitted a supplemental application to the Food and Drug Administration for the use of the drug Nexium as a short-term treatment of gastroesophageal reflux disease in infants.
GERD, which is closely related to acid-reflux disease, affects about 7 million children in the United States.
The FDA has already approved Nexium (esomeprazole magnesium) for use in children between 1 and 17 years of age, though AstraZeneca hopes to have it approved in infants less than a year old.
Amgen applies for FDA approval of denosumab osteoporosis, cancer treatment
THOUSAND OAKS, Calif. Amgen has submitted an approval application to the Food and Drug Administration for denosumab, a treatment for women with postmenopausal osteoporosis and patients undergoing hormone ablation for prostate and breast cancer, the biotech company announced Friday.
The approval application contains data from six phase 3 trials involving more than 11,000 patients, the company said. Amgen also plans to submit applications in Canada, Australia, the European Union and Switzerland.
“Today’s submission marks a significant step toward realizing our goal of making this important therapeutic available to patients at risk for fractures, for whom there is a significant need for new therapies,” Amgen EVP for research and development Roger Perlmutter said.