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POZEN Inc. (Nasdaq: POZN) $6.62. Today announced that it has been notified by AstraZeneca that marketing and pricing approval for VIMOVO (naproxen/ esomeprazole magnesium) 500/20 mg modified-release tablets, has been granted in the United Kingdom (UK). VIMOVO is indicated for the symptomatic treatment of osteoarthritis (OA), rheumatoid arthritis (RA), and ankylosing spondylitis (AS) in patients who are at risk for developing non-steroidal anti-inflammatory drug (NSAID)-associated gastric and/or duodenal ulcers and where treatment with lower doses of naproxen or of other NSAIDs is not considered sufficient.
Under the terms of its agreement with AstraZeneca, POZEN will receive a $25 million milestone payment within 20 days. As a result of the payment, the Company is confirming its 2010 year-end guidance will be net income of $21 to $23 million. Additionally, the Company's year-end cash guidance is anticipated to be $63 to $65 million.
What They Do: POZEN Inc. is a progressive pharmaceutical company that is transforming how the healthcare industry addresses unmet medical needs.
Biodel Inc. (Nasdaq: BIOD) $1.98. Today announced new findings from the company's Linjeta, insulin glargine, "smart" basal insulin and stabilized glucagon development programs in poster presentations yesterday and today at the Tenth Annual Diabetes Technology Meeting in Bethesda, MD.
Dr. Frank Flacke presented results of a Phase 1 single-center, double-blind, randomized crossover trial in 13 subjects with type 1 diabetes who received a once-daily injection of Linjeta™ or one of two modified formulations of Linjeta™, each on a separate day ("Characterization of Pharmacokinetics and Toleration of Three Variant Formulations of Linjeta™"). The purpose of the study was to compare the pharmacokinetic characteristics and toleration of Linjeta™ to the two modified formulations. The study found that the modified formulations were associated with improved toleration profiles and lower maximal insulin concentrations compared to Linjeta. Modified formulation BIOD-102 was associated with a similar rate of absorption as Linjeta.
What They Do: Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes.
Transgenomic, Inc. (OTCBB: TBIO) $0.51. Today announced that it has been awarded a research and development grant totaling $1,070,453.32 from the U.S. government under HR: 3590 – Patient Protection and Affordable Care Act (the "Act") in immediately available funds. This is among the largest awards for any one company under the Act. Four of the Company's R&D programs received the highest maximum allowable award of $244,479.25 each, including COLD-PCR, the company's ultra-high mutation detection technology, Surveyor SCAN kit development for key cancer pathway gene mutations and mtDNA Damage Assays.
Under the Act, $1 billion was earmarked for qualifying therapeutic discovery projects that treat areas of unmet medical need or prevent, detect or treat chronic or acute diseases and conditions, and/or reduce the long-term growth of healthcare costs in the United States. In addition, allocation of the credit took into consideration which projects show the greatest potential to create and sustain high-quality, high-paying U.S. jobs and to advance U.S. competitiveness in life, biological and medical sciences. Applicants were required to submit detailed information demonstrating that their research conformed to the parameters of the Act, along with a summary of qualifying expenditures that formed the basis for the award. The award of $1,070,453 represents a pro rata reduction applied to all applicants, as the program was significantly over-subscribed.
What They Do: Transgenomic, Inc. is a global biotechnology company specializing in high sensitivity genetic variation and mutation analysis, providing products and services in DNA mutation detection and discovery for clinical research, clinical molecular diagnostics and pharmacogenomics analysis.
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