Content about Clinical research

THOUSAND OAKS, Calif. — The Food and Drug Administration has approved two new uses for a drug made by Amgen, the drug maker said Monday.

Amgen announced the approval of the biotech drug Prolia (denosumab) for increasing bone mass in men and women who are at risk of fractures due to hormone ablation treatments they are receiving for prostate and breast cancer, respectively.

SILVER SPRING, Md. — The Food and Drug Administration is reorganizing its division for regulating cancer drugs, the agency said Monday.

The FDA said it would rename the Office of Oncology Products the Office of Hematology and Oncology Products. The office, which is responsible for reviewing regulatory applications for pharmaceutical and biotech drugs for cancer, is overseen by the Center for Drug Evaluation and Research. Office of Oncology Products director Richard Pazdur will continue as director of the OHOP.

MOUNTAIN VIEW, Calif. — The Food and Drug Administration has accepted a regulatory approval application for a drug made by Vivus for treating erectile dysfunction.

Vivus said it expected the Food and Drug Administration to complete its review of the application for avanafil by April 29, 2012.

"We are pleased with FDA's acceptance of our NDA," Vivus president Peter Tam said. "If approved, avanafil could be a valuable treatment alternative for the 18 million men in the United States that suffer from ED."

PRINCETON, N.J. — The Food and Drug Administration has approved a new use for a follow-on biologic made by Sandoz.

Sandoz, the generic drugs arm of Swiss drug maker Novartis, announced the approval of Omnitrope (somatropin [rDNA origin]) for children with growth failure due to Turner syndrome. Sandoz said Omnitrope was now approved for all the same indications as the reference product, Pfizer's Genotropin.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Shire for a rare autoimmune condition, the agency said.

The FDA announced the approval of Firazyr (icatibant) for acute attacks of hereditary angioedema in patients ages 18 years and older. HAE, which affects fewer than 30,000 people in the United States, results from improper function of C1 inhibitor, a protein that regulates how certain immune system and blood clotting pathways function.

THOUSAND OAKS, Calif. — The Food and Drug Administration will decide whether or not to approve a new usage for a cancer drug made by Amgen by next year, the drug maker said.

DANBURY, Conn. — With the global biosimilars market expected to expand nearly sixfold by the middle of the decade, market research firm IMS Health is launching a market-measurement tool for drug makers interested in getting into the space, the company said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug and companion diagnostic test for the most dangerous type of skin cancer, the agency said Wednesday.

The FDA announced the approval of Genentech's and Daiichi Sankyo's Zelboraf (vemurafenib), for patients with late-stage melanoma that can't be removed by surgery. Genentech is the U.S. division of Swiss drug maker Roche.

CHADDS FORD, Pa. — Profits for Endo Pharmaceutical Holdings rose to $54.6 million during second quarter 2011, up 6% from $51.5 million in second quarter 2010, the drug maker said.

Sales for the quarter were $607.5 million, compared with $396.5 million in second quarter 2010. Sales of branded drugs were $398.3 million, an 8% increase over last year, which the company attributed to better sales of the pain drug Opana ER and the joint pain drug Voltaren Gel.

SILVER SPRING, Md. — The Food and Drug Administration has reorganized the Office of Generic Drugs in an effort to improve efficiency, according to an internal memo.

The new organizational scheme will add a new division to the bioequivalence program called Division of Bioequivalence II and a new chemistry division, Division of Chemistry IV.

PHILADELPHIA — The Food and Drug Administration has approved a generic version of a short-term adjunct treatment for obesity.

Lannett said that the FDA approved its abbreviated new drug application for phentermine resin extended-release capsules in the 15-mg and 30-mg strengths. The drug, which is equivalent to UCB's Ionamin, will be sold in bariatric clinics.

INDIANAPOLIS — Eli Lilly has launched its physician payment registry, a website that enables visitors to search payments to individual U.S.-based physicians and the institutions or research organizations that receive payments on behalf of a physician.

The drug maker said that its website, which is in line with its corporate integrity agreement with the U.S. government, aims to show how the company works with U.S. physicians and compensates them for their services and how these collaborations benefit patient care.