FDA report lays quality-control accusations to rest for Mylan
PITTSBURGH The Food and Drug Administration has released its official and final report of a generic drug maker’s manufacturing plant after its quality control was brought into question by a newspaper.
Last month, the Pittsburgh Post-Gazette made accusations that a Morgantown, W.Va. manufacturing facility owned by Mylan had ignored and deleted computerized warnings of problems with drugs and the equipment used to manufacture them, according to leaked internal documents.
The newspaper article was based on improperly obtained documents, uninformed third-party commentary and anonymous sources, Mylan said. The final FDA report closes the inspection with no deficiencies found and no FDA “483” issued.
“Mylan’s manufacturing facilities — especially our plant in Morgantown — have always represented the gold standard when it comes to quality,” said Mylan CEO Robert Coury. “Without ever getting complacent, our entire management team and all of our employees continue to demonstrate an unyielding commitment to sustain the highest of quality standards. I would like to thank all of our employees for their continued hard work and execution, and I am pleased that this investigation is formally behind us.”
Study finds link between radiation therapy in children, diabetes
NEW YORK Children with cancer who undergo a common cancer therapy may be at increased risk of developing diabetes, according to research published recently in the journal Archives of Internal Medicine.
Researchers at Emory University found that childhood cancer survivors who had received total-body or abdominal radiation therapy had increased risk of developing cancer, with the risk increasing more than twofold if they received a cancer diagnosis before age 5, compared with those diagnosed in late adolescence. Out of a total of 8,599 survivors diagnosed before age 21, 2.5% developed diabetes, compared with 1.7% of their 2,936 siblings, apparently regardless of body mass index.
“It is likely that this additional chronic disease in childhood cancer survivors, who frequently also sustain damage to the heart, kidneys and endocrine system, will lead to further morbidity and premature mortality,” the authors of the study wrote. “Therefore, it is imperative that clinicians recognize this risk, screen for diabetes and prediabetes when appropriate and approach survivors with aggressive risk-reducing strategies.”
Sun sets on company’s acquisition of Taro
MUMBAI, India Indian generic drug maker Sun Pharmaceutical Industries’ tender offer to acquire Israeli drug maker Taro Pharmaceutical Industries has expired, Sun announced Thursday.
Sun said it plans to renew its offer to buy the company through subsidiary Alkaloida Chemical Co. Exclusive Group, but the offer is subject to an order issued by the Supreme Court of Israel prohibiting its closing until the court resolves litigation against Alkaloida by Taro concerning the application of Israeli laws regulating mergers and acquisitions.
Sun has sought to acquire Taro since June 2008. As of Wednesday, more than 32,000 shares of Taro had been tendered.