Reports: Congressional committee looking into compounding industry group’s practices
NEW YORK — A Congressional committee is looking into allegations that a compounding pharmacy industry association may have taught pharmacists how to sidestep requests for samples from the Food and Drug Administration, according to published reports.
Reuters reported that the House Energy and Commerce Committee had requested internal documents from the International Academy of Compounding Pharmacists, citing a news report about the organization.
The request comes amid a nationwide meningitis outbreak linked to contaminated supplies of steroid drugs prepared at the New England Compounding Center that had sickened 541 people and killed 36 in 19 states as of Monday, according to the Centers for Disease Control and Prevention.
FDA approves new indication for J&J prostate cancer drug
SILVER SPRING, Md. — The Food and Drug Administration has approved a new use for a cancer drug made by Johnson & Johnson, the agency said Monday.
The FDA announced the approval of Zytiga (abiraterone acetate), made by J&J subsidiary Janssen Biotech, for men with castration-resistant prostate cancer that has spread to other parts of the body, for use prior to receiving chemotherapy. The drug was already approved for castration-resistant prostate cancer in men who had already undergone chemotherapy treatment.
In castration-resistant prostate cancer, the cancer cells continue to grow even when men have undergone drug treatment or surgery to block testosterone, which stimulates the growth.
"Today’s approval demonstrates the benefit of further evaluation a drug in an earlier disease setting and provides patients and healthcare providers the option of using Zytiga earlier in the course of treatment," FDA Office of Oncology Drug Products director Richard Pazdur said.
Amgen buys DeCode Genetics for $415 million
THOUSAND OAKS, Calif. — Amgen is buying an Iceland-based biotech company for $415 million, the two said Monday.
Amgen announced it would acquire DeCode Genetics, based in Reykjavik, Iceland, in a deal that Amgen’s board of directors unanimously approved. Founded in 1996, DeCode focuses its business on finding links between the human genome and disease susceptibility. The acquisition is expected to close before the end of 2012 and does not require regulatory approval.
"DeCode Genetics has built a world-class capability in the study of the genetics of human disease," Amgen president and CEO Robert Bradway said. "This capability will enhance our efforts to identify and validate human disease targets. This fits perfectly with our objective to pursue rapid development of relevant molecules that reach the right disease targets while avoiding investments in programs based on less well-validated targets."