• Access Pharmaceuticals Inc., of Dallas, received FDA Phase I clearance for its investigational new drug application for AP5346. Access plans to study the drug in combination with fluorouracil and leucovorin to evaluate safety and establish a starting dose for Phase II studies. The company's stock (AMEX:AKC) lost 6 cents Friday to close at $2.78.

• Cambridge Antibody Technology Group plc, of Cambridge, UK, said in its action in the High Court in London against Abbott Laboratories, of Abbott Park, Ill., the judge announced the decision arising from procedural matters from his Dec. 20 judgment in CAT's favor. Abbott was denied permission to appeal the December ruling, though the company can apply to the Court of Appeal for permission, and Abbot also was ordered to pay CAT's legal costs. CAT said Abbott agreed to pay about £2.9 million (US$5.4 million), representing an interim payment of costs due. Abbott paid Thursday $23.7 million, representing royalty arrears due to CAT arising from the original judgment, and agreed to pay an additional $1.3 million in interest and compensation for currency lost on that amount. At issue in the case was whether Abbott was entitled to reduce the royalty rate to CAT for meet payments due to other companies that have technology featured in Humira, an anti-TNF antibody. (See BioWorld Today, Dec. 22, 2004.)

• Durect Corp., of Cupertino, Calif., and Voyager Pharmaceutical Corp., of Raleigh, N.C., completed study enrollment for the DURIN-based leuprolide acetate candidate for Alzheimer's disease, a product under joint development using Durect's drug delivery platforms and Voyager's patent covering the use of leuprolide acetate for treating Alzheimer's disease. Voyager said it expects to receive approval from the FDA for pivotal studies to begin in the last half of the year. Under the 2002 agreement between the companies, Voyager has the right to commercialize the product worldwide, while Durect will receive undisclosed milestone payments and royalties on product sales. (See BioWorld Today, July 30, 2002.)

• EPIX Pharmaceuticals Inc., of Cambridge, Mass., was accused of violating federal securities laws in a case pending in the U.S. District Court for the District of Massachusetts. The law offices of Charles J. Piven PA, announced a securities class action on behalf of shareholders who acquired shares of EPIX during the period from July 10, 2003, to Jan. 14, 2005. The company is accused of issuing false and misleading statements to the market. Earlier this month, the FDA sent EPIX an approvable letter for its imaging agent, MS-325, but asked for additional trials. (See BioWorld Today, Jan. 18, 2005.)

• Neurobiological Technologies Inc., of Richmond, Calif., said the FDA granted fast-track status for its stroke treatment, Viprinex, for its intended use in patients suffering from ischemic stroke. Viprinex (ancrod) is under development for decreasing disability in patients with acute non-hemorrhagic stroke, treated within six hours of symptoms.

• Pluristem Life Systems Inc., of Haifa, Israel, completed a $755,000 interim private placement to further its development efforts. Funds will be used to achieve the company's short-term growth objectives and to continue its stem cell development plan for cell regenerative therapy. Pluristem said, as a condition of the interim funding, the new investors were entitled to appoint two members to the company's five-person board.

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