Teva completes acquisition of Barr
JERUSALEM Teva has completed its acquisition of Barr Pharmaceuticals, the Israeli generic drug maker announced Tuesday.
Teva, already the world’s largest maker of generic drugs, said the combined company will have a presence in more than 60 countries and generate revenues of approximately $13.6 billion on a pro-forma basis for the 12 months ending Sept. 30, 2009.
“This is truly an exciting day for us,” Teva president and CEO Shlomo Yanai said in a statement. “By combining two industry-leading companies, we have established a stronger, more competitive company with increased scale and an expanded geographic footprint with significant potential for growth.”
Earlier this month, Barr announced that the Food and Drug Administration had accepted its biologics approval application for two vaccines for adenovirus, marking its first foray into biologics.
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.