• Biodel Inc., of Danbury, Conn., said the FDA granted orphan drug designation for Biodel's glucagon for the prevention of hypoglycemia in the congenital hyperinsulinism population.

• BioCryst Pharmaceuticals Inc., of Research Triangle Park, N.C., reported that in response to recent events including the termination of its planned merger with San Francisco-based Presidio Pharmaceuticals Inc. and setbacks in their peramivir and BCX5191 programs, as well as the delay in their BCX4161 program, it is restructuring and implementing a focused strategy to advance its hereditary angioedema (HAE) and antiviral programs. The restructuring includes a work force reduction of 50 percent, representing 38 positions. Excluding restructuring and deal charges, cash savings of $15 to $18 million are expected in 2013, as compared to an approximate $40 million cash use expected in 2012. The company said it will record a restructuring charge of $2 million to $4 million in the fourth quarter of 2012. The company plans to direct its cash and other resources primarily to enable the achievement of important near-term milestones for its BCX4161 HAE, BCX4430 broad-spectrum antiviral and BCX5191 hepatitis C programs.

• Cardium Therapeutics Inc., of San Diego, said that its current listing is noncompliant based on its quarterly report for the period ended Sept. 30, 2012. The company said it is required to submit a plan to staff of the exchange that would reestablish compliance with the NYSE MKT listing requirement by March 31, 2013. The company reported that it has already submitted such a plan in advance of the designated time frame.

• Catalent Inc., of Somerset, N.J., said it has been chosen as the exclusive U.S. drug supply partner for Cometriq (cabozantinib), the thyroid cancer therapy from South San Francisco-based Exelixis Inc., approved in late November. (See BioWorld Today, Nov. 30, 2012.)

• Cubist Pharmaceuticals Inc., of Lexington, Mass., said that the FDA has designated two of its Phase III antibiotic candidates, CXA-201 (ceftolozane/tazobactam) and CB-315, as Qualified Infectious Disease Products (QIDP). The designations will enable the company to benefit from certain incentives for the development of new antibiotics, including priority review, eligibility for fast-track status, and if CXA-201 or CB-315 are ultimately approved by the FDA, a five-year extension of Hatch-Waxman exclusivity. Those incentives are provided under the Generating Antibiotic Incentives Now (GAIN) Act. CXA-201 is currently being studied in pivotal Phase III trials as a first-line intravenous therapy for the treatment of complicated intra-abdominal infections and complicated urinary tract infections caused by gram-negative bacterial infections, including those caused by multidrug-resistant Pseudomonas aeruginosa. The FDA's QIDP designation applies to CXA-201's treatment of complicated intra-abdominal infections. CB-315 is currently being investigated in Phase III trials as an oral therapy for Clostridium difficile-associated diarrhea, or CDAD.

• Genzyme Corp., of Cambridge, Mass. (part of Sanofi SA), won European Commission approval of a product label expansion for the use of Thyrogen (thyrotropin alfa) with a wider irradiation dose range for postoperative thyroid remnant ablation. Thyrogen is used before radioiodine treatment to avoid temporarily discontinuing thyroid replacement therapy for postoperative thyroid remnant ablation. The revised indication in remnant ablation provides physicians with the option to administer a reduced dose of radioiodine (131-I). Previously the amount of radioiodine was specified at 100 mCi, whereas physicians may now select a dose from the range of 30 to 100 mCi.

• Invida Holdings Private Ltd., part of Menarini Group, of Florence, Italy, is changing its name to A. Menarini Asia-Pacific Holdings Pte. Ltd., to reflect alignment with parent, Menarini Group.

• Sirona Biochem Corp., of Vancouver, British Columbia, said its sodium glucose transporter (SGLT) inhibitor for Type II diabetes reduced blood glucose more effectively than canagliflozin, the investigational therapy from Janssen Research & Development LLC (Raritan, N.J.; unit of Johnson & Johnson). In the study, conducted on rates, SBM-TFC-039 significantly and rapidly reduced blood glucose levels at a dose of 1.0 mg/kg. Six hours after administration, SBM-TFC-039 reduced blood glucose by 44 percent compared to canagliflozin at 26 percent. SBM-TFC-039 also had a longer duration of effect than canagliflozin. At 36 and 48 hours after treatment, SBM-TFC-039, at a dose of 1 mg/kg, was still effective at reducing blood glucose, whereas canagliflozin lost its effect after 36 hours. Studies were conducted on Zucker Diabetic Fatty rats.