• Access Pharmaceuticals Inc., of Dallas, appointed chairman Jeffrey Davis CEO, replacing Stephen Seiler. Access is developing ProLindac, a DACH platinum drug in ovarian cancer, and MuGard, a drug for mucositis.

• Aspreva Pharmaceuticals Corp., of Victoria, British Columbia, said the minister of industry, under the Investment Canada Act, approved the firm's acquisition by Berne, Switzerland-based Galenica Group for $26 per share, or about $915 million. The deal, first announced in October, was approved by Aspreva shareholders last week and is expected to close Jan. 3. (See BioWorld Today, Oct. 19, 2007.)

• Cubist Pharmaceuticals Inc., of Lexington, Mass., agreed to acquire Seattle-based Illumigen Biosciences Inc., about two months after it gained an exclusive option to buy the early stage firm. Under the terms, Cubist will pay Illumigen stockholders $9 million in cash, and agreed to make milestone payments of up to $75.5 million for further development of IB657 in hepatitis C virus infections and payments of up to $117 million for development of Illumigen products for viruses other than HCV. Assuming that HCV or other Illumigen antiviral products are commercialized, additional milestones up of to $140 million, plus tiered royalties, could apply. Cubist expects to file an investigational new drug application for IB657 in 2008. (See BioWorld Today, Oct. 18, 2007.)

• The FDA, in Rockville, Md., issued a second safety warning about the fentanyl transdermal system and said it has continued to receive reports of death and life-threatening side effects, despite a similar warning issued in July 2005. The warning letter states that the directions on the product label and on the package insert should be followed exactly to avoid overdose. The agency also is asking manufacturers to update product information and develop a medication guide for patients. The fentanyl skin patch, approved in 1990, contains opioid fentanyl and is manufactured by Janssen Pharmaceutica Products LP, a unit of New Brunswick, N.J.-based Johnson & Johnson, under the brand name Duragesic. A generic patch is sold by St. Albans, Vt.-based Mylan Technologies Inc. (See BioWorld Today, July 22, 2005.)

• Genta Inc., of Berkeley Heights, N.J., was notified that it no longer complies with Nasdaq's minimum closing bid price of $1 for at least 10 consecutive business days. If the company does not regain compliance, it can appeal a delisting determination. In other listing news, Ann Arbor, Mich.-based Aastrom Biosciences Inc. and Boulder, Colo.-based Tapestry Pharmaceuticals Inc. both were notified that their respective shares had fallen below the minimum closing bid price of $1 for 30 consecutive days. Those companies were provided 180-day compliance periods.

• Jazz Pharmaceuticals Inc., of Palo Alto, Calif., received an approvable letter for its once-a-day Luvox (fluvoxamine maleate) extended-release capsules in social anxiety disorder and obsessive compulsive disorder. Luvox is partnered with Marietta, Ga.-based Solvay Pharmaceuticals Inc. In its letter, the FDA requested information related to the companies' response concerning previously disclosed CMC (chemistry, manufacturing and controls) issues, and the firms said they are working with the agency to resolve those concerns. Jazz said the approvable letter did not raise any questions related to the product's safety or efficacy.

• Jerini AG, of Berlin, said the FDA accepted the new drug application for Icatibant in hereditary angioedema for priority review and issued a PDUFA date of April 26, 2008. The agency also scheduled a Pulmonary-Allergy Drugs Advisory Committee meeting for Feb. 20. Icatibant is a synthetic peptidomimetic designed to work by blocking the B2 receptor as an antagonist to the peptide hormone bradykinin. The drug previously was granted orphan status in HAE.

• Pfizer Inc., of New York, received an approvable letter for dalbavancin HCl, a once-weekly, two-dose antibiotic in adult patients with complicated skin and skin structure infections, including those caused by Methicillin-resistant Staphylococcus aureus. The company did not provide specific details from the FDA's action letter but said the agency recently published draft guidance on non-inferiority studies as the basis for approval of antibacterial drug products and, therefore, is requesting additional dalbavancin data. Pfizer, which acquired rights to the drug through its 2005 acquisition of King of Prussia, Pa.-based Vicuron Pharmaceuticals Inc. in a $1.9 billion deal, said it is working with the FDA to respond to those issues. (See BioWorld Today, June 17, 2005.)