FDAnews Drug Daily Bulletin

A federal court has issued preliminary approval for a $36 million settlement agreement that would resolve allegations that New Jersey-based drugmaker Organon USA engaged in anticompetitive acts related to its depression drug Remeron.

The FDA has made significant revisions to a November 1999 guidance that provides recommendations on the types of drug impurity data included with drug applications.

Two prominent Democratic senators have announced FDA reform plans -- one calling for the government to require certain postmarketing studies on drug products, and another proposing the creation of a new drug safety watchdog office under the auspices of the FDA commissioner.

A bipartisan bill proposing sales restrictions on certain cold medicines commonly used to produce methamphetamine is gaining steam in the Senate, much to the chagrin of advocacy organizations that contend the proposal would limit consumer access to popular cold treatments such as Sudafed and Tylenol flu medicine.

Biolex, a privately held protein therapeutics company, has announced the signing of a new agreement with Medarex, an antibody therapeutics company, to create a commercial line for an undisclosed Medarex monoclonal antibody using the Biolex LEX System.

There is no way Merck will have to declare bankruptcy over pending Vioxx litigation, nor is it considering a major merger, the company's chief declared.

DOR BioPharma said it has agreed to privately sell securities to institutional investors for $3.77 million in gross proceeds.

Staff at Schering-Plough, which is based at Brinny near Innishannon in West Cork, were recently told by management that the workforce at the plant is to be reduced from around 700 to 545 over the next three months.

Basilea Pharmaceutica AG has entered into an exclusive worldwide agreement with Cilag AG International, a Johnson & Johnson company, to develop, manufacture and market ceftobiprole, Basilea's novel broad-spectrum cephalosporin antibiotic that has activity against methicillin-resistant Staphylococcus aureus (MRSA).

Novavax, a specialty pharmaceutical company, has received a three-year contract from NIH to develop a Severe Acute Respiratory Syndrome (SARS) vaccine using its proprietary Virus Like Particle (VLP) technology.

Pharmaceutical company Novartis AG (NVS) has said it will launch a new share-buyback program valued at up to CHF4 billion, but stressed that it will maintain strategic flexibility despite the cash outflow.

Intendis GmbH has started operations as a new, fully integrated pharmaceutical company, dedicated to the development and marketing of systemic and topical treatments for skin disorders.