FDAnews Drug Daily Bulletin

Patent settlements between brand and generic drugmakers have increased in recent years, and the agreements are being completed without payments from the brand to the generic in exchange for the generic's commitment not to market the product, according to a new federal study.

In a recent court decision that indicates authorized generics may be here to stay, Judge Reggie Walton of the U.S. District Court for the District of Columbia denied Teva Pharmaceutical's motion for summary judgment in a lawsuit the generic drugmaker filed against the FDA.

GlaxoSmithKline (GSK) has agreed to sell the majority of its international co-promotion rights to erectile dysfunction drug Levitra to Bayer for approximately $260 million.

New research showing that Genentech's colorectal cancer drug Avastin may pose an increased risk of arterial thromboembolic events in patients undergoing chemotherapy has prompted the firm to alter the drug's labeling.

C.R. Bard, a New Jersey company, said it is buying the assets of Genyx Medical, related to its implantable treatment for incontinence, for $60 million.

Bradley Pharmaceuticals has reached agreement with DPT Laboratories and its affiliate DPT Lakewood to continue manufacturing Zonalon, a topical dermatological preparation, and other products.

Oxxon Therapeutics has licensed exclusive worldwide rights to Xenova Group's DISC-HSV and DISC-GM-CSF vector platforms for use in developing products for certain major cancers and chronic infectious diseases.

Kendle, a leading, global full-service clinical research organization, today announced the opening of an office in New Delhi, India, further expanding its access to large patient populations in the Asia/Pacific region.

Kobayashi Pharmaceutical has acquired a sole distributorship for Inochi-No-Haha A, a special supplement for females manufactured and distributed by Sasaoka Yakuhin.

Lasky & Rifkind, a law firm with offices in New York and Chicago, has announced that a lawsuit has been filed in the United States District Court for the Southern District of New York, on behalf of persons who purchased or otherwise acquired publicly traded securities of Atherogenics between Sept. 28, 2004 and Dec. 31, 2004, inclusive.

Roche Holding AG has won European Union approval for its colon cancer treatment Avastin, which helped drive growth at the Swiss drugmaker last year after sales got off to a flying start in the U.S. Roche said on Friday that the drug had been granted marketing approval by EU regulators, as expected, as a first-line treatment for colon cancer in combination with certain kinds of chemotherapy.

Alltracel Pharmaceuticals has announced that following the successful EGM and re-admission of the company's enlarged issued share capital to trading on AIM it has now formally acquired the entire issued share capital of Westone Products, for a total consideration of up to EUR8m, in a mixed cash and paper offer.