Archive for December, 2009

Chinese medicine firm employs Cambridge University to research remedies

Hutchison Chi-MedHutchison Chi-Med has signed up the University of Cambridge to investigate the potential healing and anti-aging properties of a number of the group’s herbal remedies. Aim-listed Chi-Med sells traditional medicines in China and also has a research and development laboratory in Shanghai where its scientists analyse herbal remedies, some dating back 2,000 years, to establish their active ingredients.

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Endo Pharmaceuticals Provides Regulatory Update on AVEED(TM) Injection

Endo PharmaceuticalsEndo Pharmaceuticals has announced that it received a complete response letter from the FDA regarding the New Drug Application (NDA) for its extended-duration testosterone undecanoate injection, AVEED(TM), for men diagnosed with low testosterone. Low testosterone is also known as hypogonadism. In the complete response letter, the FDA has requested information from Endo to address the agency’s concerns regarding very rare but serious adverse events, including post-injection anaphylactic reaction and pulmonary oil microembolism.

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Astellas and XenoPort Announce Submission of a New Drug Application in Japan

Astellas Pharma IncAstellas Pharma Inc. and XenoPort, Inc. have announced that a new drug application (NDA) has been filed with the Pharmaceuticals and Medical Device Agency (PMDA) in Japan for ASP8825 (gabapentin enacarbil), also known as XP13512, as a potential treatment for restless legs syndrome (RLS). The acceptance of filing of the NDA triggers a $5 million milestone payment from Astellas to XenoPort.

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Targeted Breast Ultrasound Could Reduce Need For Invasive Biopsies For Women Under 40

University ofUniversity of Washington researchers explored the effectiveness of targeted breast ultrasound showed it was able successfully to tell the difference between benign and cancerous tumors in young women with lumps or other specific, localized signs or symptoms of breast cancer; so much so that the researchers recommended this method as a “tool of choice” for evaluating palpable lumps in women under 40, thus reducing the need for invasive biopsies.

Bristol-Myers’ Abilify To Treat Irritabilty In Pediatric Patients With Autistic Disorder gets FDA Approval

Bristol Myers SquibbBristol-Myers Squibb Co. and Otsuka Pharmaceutical Co., Ltd. said that FDA has approved the supplemental New Drug Application or sNDA for Abilify for the treatment of irritability associated with autistic disorder in pediatric patients of ages 6 to 17 years. The approval of Abilify for the treatment of irritation in patients with autistic disorder in pediatric patients is based on data from two eight-week, randomized, double-blind, placebo-controlled, multi-center, Phase III studies.