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MediciNova receives FDA approval to proceed with initial trial of ibudilast

MediciNova Inc, a biopharmaceutical company publicly traded on the NASDAQ Global Market and the Hercules Market of the Osaka Securities Exchange (Code Number:4875), today reported FDA's approval to proceed with an initial trial of the company's neurological drug candidate, ibudilast (MN-166/AV411), as a potential new pharmacotherapy for methamphetamine addiction.

27 Sep 2010

FDA approves Beyaz tablets to increase folate level in women

The U.S. Food and Drug Administration today approved Beyaz tablets, an estrogen/progestin combined oral contraceptive that also contains a folate (levomefolate calcium 0.451 mg).

27 Sep 2010

Astellas Pharma announces Phase IV study results of Lexiscan injection at ASNC session

Today Astellas Pharma US, Inc. announced results of a Phase IV study showing Lexiscan(regadenoson) Injection was comparable to placebo in causing a >15% decrease in forced expiratory volume in one second (FEV1) in subjects with asthma or chronic obstructive pulmonary disease (COPD) who are likely candidates for myocardial perfusion imaging (MPI) studies.

27 Sep 2010

Calcitonin combination therapy may help treat osteoarthritis: Study

Tarsa Therapeutics, Inc. and Unigene Laboratories, Inc. today reported preclinical data showing that calcitonin may have synergistic effects in combination with other drugs in reducing the collagen degradation associated with osteoarthritis.

27 Sep 2010

Stirling Products’ drug delivery technology interests big ‘pharma’

Healthcare group, Stirling Products Limited (ASX:STI) has advised that following the recent TeleMedCare e-health acquisition and the conditional addition of the recently announced pathology business (subject to due diligence completion and shareholder approval), the Company is now in process of its strategised business integration.

26 Sep 2010

Genta commences new tesetaxel Phase 2 clinical trial in advanced bladder cancer

Genta Incorporated today announced that the Company has initiated a new Phase 2 clinical trial of tesetaxel in patients with advanced bladder cancer. Tesetaxel is the leading oral taxane in clinical development. The new trial will be conducted at Memorial Sloan-Kettering Cancer Center, New York, NY, the Kimmel Cancer Center at Jefferson University, Philadelphia, PA, and at least one site in the EU.

24 Sep 2010

Cylene commences CX-4945 Phase I trial in multiple myeloma

Cylene Pharmaceuticals, Inc. announced today the initiation of a Phase I clinical trial of their first-in-class, oral CK2 inhibitor CX-4945 in patients with multiple myeloma. Cylene also announced the simultaneous closing of a $12 million financing with participation from existing investors including Sanderling Ventures, HBM BioVentures (Cayman) Ltd., Novartis BioVenture Fund, BioVentures Investors, Lilly Ventures, Mitsui & Co. and Morningside Venture Investments Ltd.

24 Sep 2010

Phase 3 clinical study demonstrates efficacy of metformin therapy in type 2 diabetes

Bristol-Myers Squibb Company and AstraZeneca today announced results from a randomized, double-blind Phase 3 clinical study in adults with type 2 diabetes inadequately controlled on metformin therapy alone.

24 Sep 2010

Researchers discover new signaling pathway for cell development

Researchers at UCLA's Jonsson Comprehensive Cancer Center have discovered a new cell signaling pathway that controls cell growth and development, a pathway that, when defective, helps promote the formation of several major forms of human cancer, including lymphoma and leukemia.

24 Sep 2010

FDA approves Bionovo's CMC plan for Menerba drug candidate

Bionovo, Inc. announced today that the U.S. Food and Drug Administration (FDA) accepted the Company's Chemistry, Manufacturing and Controls (CMC) plan for its lead drug candidate, Menerba, in a Type "B" or "End of Phase 2" meeting.

24 Sep 2010

Abbott, Reata enter agreement to commercialize bardoxolone drug for CKD

Abbott and Reata Pharmaceuticals today announced that they have entered into a collaboration agreement to develop and commercialize bardoxolone methyl (bardoxolone), which is currently in late Phase 2 trials for the treatment of chronic kidney disease (CKD).

24 Sep 2010

Surefil emerges from Chapter 11 protection with Federal Court approval

Surefil, a contract manufacturer of liquid-fill products for the personal care, home care, oral care, medical industries, and energy drinks, emerged from Chapter 11 protection with Federal Court approval on September 15, 2010.

23 Sep 2010

Linagliptin clinical trial data shows positive result for type 2 diabetes treatment

New data from the linagliptin late stage clinical trial programme were presented this week at the 46th Annual Meeting of the European Association for the Study of Diabetes (EASD).

23 Sep 2010

Phase II study: Fostamatinib improves outcomes in RA patients

AstraZeneca's new oral syk inhibitor, fostamatinib (R788), recently in-licensed from Rigel Pharmaceuticals, Inc., significantly improved outcomes of patients with rheumatoid arthritis who responded inadequately to ongoing treatment with methotrexate, according to phase II study data published in The New England Journal of Medicine today.

23 Sep 2010

Genetic variation in taste pathway genes associated with dental caries risk

Dental caries is a highly prevalent disease that is disproportionately distributed in the population. Caries occurrence and progression is known to be influenced by a complex interplay of both environmental and genetic factors, with numerous contributing factors having been identified including bacterial flora, dietary habits, fluoride exposure, oral hygiene, salivary flow, salivary composition, and tooth structure. Previous reports have characterized the influence of the genetic variation on taste preferences and dietary habits.

23 Sep 2010

Chromium picolinate may cure inflammation associated with diabetic nephropathy: Research

Taking chromium picolinate may help lessen inflammation associated with diabetic nephropathy (kidney disease), say researchers at the Medical College of Georgia in Augusta.

23 Sep 2010

FDA and EMA accept regulatory submissions of vandetanib for advanced medullary thyroid cancer

AstraZeneca today announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted regulatory submissions for review of the investigational drug vandetanib in the treatment of patients with advanced medullary thyroid cancer (MTC). The FDA also granted priority review status for the new drug application and set a Prescription Drug User Fee Act (PDUFA) action date of 7 January 2011.

23 Sep 2010

FDA approves fingolimod drug for multiple sclerosis

The first oral medication for multiple sclerosis was approved today by the Food & Drug Administration. Physicians praised the decision to approve the drug, called fingolimod, saying it would give multiple sclerosis patients new options for treatment.

23 Sep 2010

Biogen Idec concurs with FDA on safety monitoring for Gilenya through REMS

Biogen Idec is committed to improving the lives of people with multiple sclerosis (MS), and no company is doing more for these patients. There has been a desire within the MS community for an oral treatment for a long time, and the approval of Gilenya has made this a reality.

23 Sep 2010

Scientists develop humanized mouse model to study typhoid fever

Better treatments and prevention for typhoid fever may emerge from a laboratory model that has just been developed for the disease. The model is based on transplanting human immune stem cells from umbilical cord blood into mice that are susceptible to infections.

23 Sep 2010