FDAnews Drug Daily Bulletin

The FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) has issued Johnson & Johnson subsidiary Centocor an untitled letter for a visual aid that it says misrepresents the effectiveness of rheumatoid arthritis (RA) drug Remicade.

The FDA has published a new draft guidance that provides recommendations on how the public, including industry representatives, may participate in open public hearing sessions conducted as part of advisory committee meetings.

A new study of several clinical research trials involving Cox-2 inhibitors suggests the drugs increase blood pressure more than conventional nonsteroidal anti-inflammatory drugs (NSAIDs).

The Senate sponsors of a medical malpractice reform bill have removed an earlier provision that would have shielded drugmakers from punitive damages if they followed all necessary FDA guidelines when seeking approval of their products.

Nautilus Biotech has reached the first milestone in its collaboration with Serono to develop a next-generation human growth hormone with an improved pharmacological profile.

Biopharmaceutical company Insmed has filed a motion to dismiss a lawsuit filed by Tercica and Genentech over efforts to commercialize its growth hormone SomatoKine in the U.S. The company said its activities concerning SomatoKine fall under federal clinical trial exemptions that prevent patent infringements from being filed against a product that is being tested in clinical trials.

Billionaire investor Carl Icahn has filed a lawsuit against generic drugmaker Mylan Laboratories and its directors in a Pennsylvania court, challenging Mylan's recent bylaw amendments that require any director nominations be completed within the next week.

Medco Health Solutions, the largest U.S. pharmacy-benefit manager, agreed to buy Accredo Health for about $2.2 billion to expand its administration of drugs for hard-to-treat diseases such as hemophilia.

Sentigen Holding has sold the Specialty Media Division of its wholly owned subsidiary, Cell & Molecular Technologies to Chemicon International, a wholly owned subsidiary of Serologicals Corporation.

Sosei has in-licensed a urology compound OPC-51803 (Sosei code SOU-003) from Otsuka Pharmaceutical who has already completed Phase I human studies.

Symyx Technologies has signed a definitive agreement to acquire privately-held Synthematix, based in Research Triangle Park, N.C. Synthematix is a provider of organic synthesis reaction planning software systems for scientific knowledge management in chemistry research, with customers primarily in the pharmaceutical and biotechnology industries.

Illumina has signed a definitive agreement and plan of merger with CyVera, a privately held Connecticut-based company, pursuant to which CyVera will become a wholly owned subsidiary of Illumina.