FDAnews Drug Daily Bulletin

The FDA has issued a nationwide alert to healthcare facilities warning against using a certain lot of magnesium sulfate solution, which the agency said may contain harmful bacteria.

A proposal to grant the HHS secretary the authority to negotiate Medicare drug prices with manufacturers has been defeated in the Senate by a single vote.

The FDA is nearing approval of a proposal that will grant OTC status to Barr Pharmaceuticals' emergency contraceptive Plan B, according to the agency's acting Commissioner Lester Crawford.

Eli Lilly's Xigris may increase the risk of death in sepsis patients with single-organ dysfunction who recently underwent surgery, the FDA warned in a MedWatch alert.

Celgene announced that it has signed a licensing agreement with EntreMed Corporation whereby EntreMed has been granted rights to the development and commercialization of Celgene's tubulin inhibitor compounds, a class of orally available, anti-proliferative compounds that have demonstrated, in preclinical models, activity against drug-resistant cancer cells, inhibition of inflammatory cytokines and anti-angiogenic activity.

Savient Pharmaceuticals, Inc. has signed a definitive agreement with Ferring Pharmaceuticals, a subsidiary of Ferring B.V., to enter a co-promotion agreement to market Nuflexxa (1 percent Sodium Hyaluronate) in the United States.

Biotechnology company Icoria, announced that it is transitioning from agricultural R&D activities to concentrate on an aggressive program to discover and validate targets and potential drug candidates for the treatment of diabetes, obesity and liver injury.

GlaxoSmithKline Plc said on Thursday its asthma drug Advair/Seretide beat AstraZeneca Plc's Symbicort in a one-year clinical study, reviving rival claims about the two products.

The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals Ltd (Orchid), has entered into an exclusive agreement with STADA Pharmaceuticals Inc, the U.S. subsidiary of STADA Arzneimittel AG, for the development and supply of six prescription generic drug products to STADA for the US market.

Biologics contract manufacturer Omnia Biologics, Inc. (Rockville, Md.) and biopharmaceutical technology development company, AT-GC BioPharm, Inc. (Baltimore, Md.) announced the signing of a strategic alliance to develop AT-GC Electronic Eye technology for the manufacture of biopharmaceutical products.

Two big Japanese drugmakers are merging -- and New Jersey is the loser. Next month, Yamanouchi Pharmaceuticals and Fujisawa Pharmaceuticals will form Astellas Pharma, and locate their U.S. headquarters in Fujisawa offices in Deerfield, Ill.

Lion Bioscience AG said shareholder Ian Humphrey-Smith has informed its extraordinary general meeting of a possible takeover offer for the company by a group of investors.

Iowa residents will have to show ID and sign their names when buying cold medicines containing pseudoephedrine under an anti-methamphetamine law approved by state lawmakers this week.