FDAnews Drug Daily Bulletin

Amit Sachdev, one of the FDA's top policy officials, has resigned from the agency, acting FDA Commissioner Lester Crawford announced.

Coley Pharmaceutical has signed an exclusive global license agreement with Pfizer that will allow the drug giant to develop, manufacture and market Coley's experimental cancer treatment ProMune.

Wyeth Pharmacueticals has reformulated and renamed its tuberculosis treatment, Trecator-SC, the FDA said in a recent MedWatch alert.

A trio of final guidance documents focused on developing new ways to minimize the safety risks of prescription drugs and biologics are not expected to lengthen the product-approval process, a top FDA official said.

Vicuron Pharmaceuticals Inc. said Wednesday after the closing bell that its collaboration with Pfizer Inc. has been extended for another year.

ICOS Corporation and privately held Caprion Pharmaceuticals Inc. announced that they have entered into an agreement for the joint development of therapeutic antibodies for the treatment of cancer.

Serono and Syntonix Pharmaceuticals Inc. announced that they have entered into an agreement under which Serono has licensed worldwide exclusive rights to Syntonix' Transceptor and Synfusion technologies for the development and commercialization of interferon-beta:Fc products. Syntonix' technologies may enable the development of an interferon-beta therapy for multiple sclerosis (MS) that can be administered by inhalation.

Lexicon Genetics reached an agreement to settle its claim in Deltagen bankruptcy proceedings and said its first-quarter revenue will exceed the high end of its previous guidance as a result of the deal.

Sanofi pasteur, the vaccines business of the sanofi-aventis group, has received a license from the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) for a new polio vaccine, which is the first new vaccine developed to fight that disease in decades.

The Aeras Global TB Vaccine Foundation of Bethesda, Maryland and Statens Serum Institut (SSI) of Copenhagen, Denmark, announced a new collaboration on the preclinical and clinical development of SSI's tuberculosis (TB) vaccine, HyVac4.

Australian scientists have identified an enzyme that destroys cartilage in mice and believe the find may lead to new drugs which stop cartilage joint deterioration and painful arthritis in humans.

Cardiome Pharma Corp. announced that the underwriters of its recently completed public offering have exercised their over-allotment option in full, purchasing an additional 1,275,000 common shares for gross proceeds of approximately US$7.6 million.