FDAnews Drug Daily Bulletin

The overall quality of direct-to-consumer (DTC) advertising has been declining, according to the head of the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC), which last year issued a record number of warning letters for violations of the agency's ad requirements.

A national coalition led by PhRMA will spend roughly $30 million through June to develop and promote a program that would help low-income Americans gain access to the medicines they need.

The FDA has appointed former Justice Department official Sheldon Bradshaw as its chief counsel, effective April 1.

North Carolina-based drug developer aaiPharma is on the verge of seeking Chapter 11 bankruptcy protection after missing a recent interest payment.

Nabi Biopharmaceuticals said it intends to offer $125 million in notes to raise money for, among other things, clinical trials.

Pharmexa has entered into an agreement to acquire GemVax AS, a private Norwegian biotech company focusing on cancer vaccines. The purchase price will be paid in newly issued Pharmexa shares and by issuance of a convertible debt instrument.

OnSource announced that it executed a definitive agreement to merge (the "Merger Agreement") with Osmotics Pharma (OPI). OPI is an emerging specialty pharmaceutical company focused on developing prescription products for the treatment of various dermatological disorders, antibiotic-resistant strains of bacteria and certain cancers.

DiObex, a biotechnology company developing therapeutics for the treatment of metabolic diseases, announced the conclusion of a worldwide exclusive license agreement with Cortendo Invest AB of Gothenburg, Sweden.

Janus Pharmaceuticals Inc. (Janus) announced the closing of the company's Series A financing round for a total of over $2 million. Lead investor was Private Equity Japan Co., Ltd (PEJ). of Tokyo, Japan. Commensurate with this funding, Mr. Shinji Kimura Managing Director, PEJ, joins the Janus Board of Directors.

Drug companies could face restrictions on advertising medicines under a Federal Government Budget push to prevent a blowout in Australia's pharmaceutical benefits scheme (PBS).

Cellegy Pharmaceuticals announced that it has entered into a settlement agreement with PDI, Inc. resolving the lawsuits that the companies had filed against each other relating to an exclusive license agreement for Cellegy's Fortigel (testosterone gel) product candidate in North American markets.

CortDev announced that Botaniex has purchased a 16.5-acre parcel of land in Zhaoqing High Technology Industry Development Zone, Guangdong Province, China.