Sanofi-aventis on Tuesday reported study results comparing the efficacy and safety of its experimental anti-arrhythmic drug Multaq (dronedarone) to amiodarone in patients with persistent atrial fibrillation (AF). The results showed that Multaq appeared safer than amiodarone when gastrointestinal events were excluded, while the treatment led to significantly more occurrences of the composite primary endpoint.

In the [...]

Popularity: 12% [?]

Amgen announced that it filed denosumab for approval to the FDA to treat and prevent postmenopausal osteoporosis in women, as well as to treat bone loss in patients undergoing hormone ablation for either prostate or breast cancer.
The filing contains data from six late-stage studies involving more than 11 000 patients, Amgen stated, adding that it [...]

Popularity: 10% [?]

Johnson & Johnson announced that the company received a complete response letter from the FDA requesting additional information on the drugmaker’s psoriasis drug ustekinumab before rendering a final decision on the treatment. The company is seeking marketing approval for ustekinumab as a subcutaneous treatment for patients with chronic moderate-to-severe plaque psoriasis.

The FDA asked for a [...]

Popularity: 9% [?]

GlaxoSmithKline on Thursday reported that the company will undertake the first late-stage trial to test the long-term efficacy of its experimental Lp-PLA2 inhibitor darapladib in patients with chronic coronary heart disease. Patrick Vallance, head of GlaxoSmithKline’s drug discovery division, stated that “we are prepared to take a risk in an area where risk-taking is necessary [...]

Popularity: 13% [?]

Based on these data, Merck has moved rapidly into late-stage clinical development to further evaluate ZOLINZA in combination with bortezomib for advanced multiple myeloma.

Popularity: 13% [?]

GlaxoSmithKline stated that the company intends to submit an application for the drug this year in Europe, where it will be marketed as Revolade, if approved.

Popularity: 14% [?]

Johnson & Johnson announced that the FDA approved the company’s oral analgesic tapentadol to treat moderate-to-severe acute pain in adults. The drugmaker licensed the US marketing rights for the treatment from Grunenthal.

The approval was based on data from more than 2100 patients, according to Johnson & Johnson. The file will now be reviewed by the [...]

Popularity: 14% [?]

As part of the study, researchers randomly assigned 4065 males between the ages of 16 and 26 to receive three injections of either Gardasil or placebo over a six-month period.

Popularity: 28% [?]

Findings presented at the American Heart Association scientific sessions on Wednesday demonstrated that GlaxoSmithKline’s Avandia (rosiglitazone) failed to significantly slow progression of atherosclerosis in patients with type 2 diabetes, compared with the sulphonylurea glipizide, marketed by Pfizer as Glucotrol.

Participants in the 672-patient APPROACH trial were randomly assigned either Avandia or glipizide. After 18 months of [...]

Popularity: 38% [?]

Johnson & Johnson and Bayer announced Monday that results from a Phase II dose-finding study of anticoagulant Xarelto (rivaroxaban) demonstrated “encouraging response rates” in patients with acute coronary syndrome (ACS). The companies stated that the data, which were presented at the American Heart Association’s Scientific Sessions, support moving Xarelto into Phase III testing for the [...]

Popularity: 26% [?]