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FDA advisory committee recommends approval of Novartis' FTY720 for relapsing MS

Today, an advisory committee of the US Food and Drug Administration (FDA) recommended approval of FTY720 (fingolimod) for the treatment of patients with relapsing multiple sclerosis, the most common form of the disease. The FDA has the option of seeking the advice of one of its advisory committees as it reviews and decides whether to approve a new treatment. The committee voted unanimously that FTY720 demonstrated substantial efficacy in treating relapsing remitting MS and that safety of the proposed 0.5 mg dose justified approval.

11 Jun 2010

EC approves Nivestim for prevention of FN

Hospira announced today that the EC has approved Nivestim™ (filgrastim) for the prevention of FN, the most serious haematological toxicity that occurs as a result of cancer chemotherapy. Nivestim now has marketing authorisation in all EU member states. Nivestim is expected to reduce the cost of neutropenia treatment.

10 Jun 2010

Onset Therapeutics expands sales force by over 50% in 2010

Onset Therapeutics, a specialty pharmaceutical company focused in dermatology, today announced the completion of the Company's latest sales force expansion initiative designed to provide national dermatology coverage to support the success of two recently launched products and the Company's rapidly growing pipeline of products in various stages of development.

10 Jun 2010

Boston Scientific's TAXUS Element Paclitaxel-Eluting Coronary Stent System launched in Europe

Boston Scientific Corporation today announced the market launch and first implants of its TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System in the European Union and other CE Mark countries. The TAXUS Element Stent System is the Company's third-generation drug-eluting stent (DES) technology and incorporates a platinum chromium alloy with an innovative stent design and an advanced catheter delivery system. It received CE Mark approval last month, which included a specific indication for the treatment of diabetic patients.

10 Jun 2010

Neutralizing inhibitory molecules does not improve regeneration in damaged spinal axons

Neuroscientists at the University of California, San Diego School of Medicine have found that removing three key inhibitory molecules from myelin - the insulating material that surrounds nerve cell fibers - does not significantly boost the ability of injured spinal axons to regenerate and restore themselves to full function.

10 Jun 2010

MAP Pharmaceuticals to present new analyses from LEVADEX Phase 3 trial for acute migraine at 52nd AHS

MAP Pharmaceuticals, Inc. today announced that the Company will present new analyses from the FREEDOM-301 Phase 3 trial of its investigational LEVADEX™ orally inhaled migraine therapy. The post hoc analyses will be presented at the 52nd Annual Scientific Meeting of the American Headache Society (AHS) in Los Angeles, California.

10 Jun 2010

Preclinical data of VB-201 to be presented at EULAR Annual European Congress of Rheumatology

VBL Therapeutics, a clinical-stage biotechnology company committed to the development of novel treatments for immune-inflammatory diseases and cancer, today announced the upcoming presentation of preclinical data from the company's lead program, VB-201, at the European League Against Rheumatism Annual European Congress of Rheumatology.

10 Jun 2010

UC emergency medicine assistant professor compares efficacy of two seizure medications to prevent SE

When seizures strike, the most immediate goal for caregivers is to get appropriate medication to the patient as quickly as possible to stop the seizing activity. In a paper published in the June Academic Emergency Medicine, UC emergency medicine assistant professor Jason McMullan, MD, found that the best means of stopping status epilepticus may be with the least direct medication.

10 Jun 2010

Aeterna Zentaris reports final results on clinical activity of perifosine for metastatic colorectal cancer

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today reported final results on the clinical activity of perifosine (KRX-0401), the Company's novel, potentially first-in-class, oral anticancer agent that inhibits Akt activation in the phosphoinositide 3-kinase pathway, in combination with capecitabine (Xeloda) as a treatment for advanced, metastatic colorectal cancer.

10 Jun 2010

Cognitive-behavioral, skills-based treatment intervention program shows promise for teenagers with IBD

Disease is a private matter to many of us. For many reasons, we want to keep it to ourselves, and no cluster of disorders challenges patients' need for privacy more than inflammatory bowel disease.

10 Jun 2010

Sialidase improves nerve regrowth, motor recovery and nervous system function: Researchers

Once damaged, nerves in the spinal cord normally cannot grow back and the only drug approved for treating these injuries does not enable nerve regrowth. Publishing online this week in the Early Edition of the Proceedings of the National Academy of Sciences, researchers at the Johns Hopkins University School of Medicine show that treating injured rat spinal cords with an enzyme, sialidase, improves nerve regrowth, motor recovery and nervous system function.

10 Jun 2010

TF2 bispecific antibody pretargeted therapy prolongs survival in animal model of human colonic cancer

Immunomedics, Inc., a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced that pretargeted therapy with TF2, a bispecific antibody against carcinoembryonic antigen (CEA) and a small peptide, delayed tumor growth and prolonged survival in an animal model of human colonic cancer.

10 Jun 2010

CoLucid's lasmiditan NAAMA effective in treatment of acute migraine attacks

CoLucid Pharmaceuticals, Inc.,, an innovative biotechnology company focusing on therapies for central nervous system disorders, today announced that its investigational first-in-class Neurally Acting Anti-Migraine Agent (NAAMA), lasmiditan (also known as COL-144), a selective 5-HT1F receptor agonist, was effective when given orally to treat acute migraine attacks, as documented in a Phase IIb study.

10 Jun 2010

New information to help patients make important decision regarding stem cell treatments

Patients hoping to learn more about the credibility of clinics selling stem cell treatments abroad will soon have new information to help them make important and often costly decisions regarding their health. A report released today by the Task Force on Unproven Stem Cell Treatments, convened by the International Society for Stem Cell Research outlines criteria by which people can evaluate the claims made by the hundreds of so-called "rogue" clinics operating across the globe.

10 Jun 2010

NICE decides not to recommend lapatinib for women with advanced breast cancer

The National Institute for Health and Clinical Excellence has decided not to recommend the oral drug lapatinib (Tyverb) for women with advanced breast cancer, except for use in clinical trials.

10 Jun 2010

FDA approves Roxane Laboratories' Valacyclovir Hydrochloride Tablets ANDA

Roxane Laboratories, Inc. announced today the Abbreviated New Drug Application (ANDA) approval of Valacyclovir Hydrochloride Tablets 500mg and

10 Jun 2010

Regeneron's ARCALYST prevents gout attacks in Phase 3 study of patients initiating allopurinol therapy

Regeneron Pharmaceuticals, Inc. announced that a Phase 3 study in gout patients initiating allopurinol therapy to lower their uric acid levels showed that ARCALYST (rilonacept), also known as IL-1 Trap, prevented gout attacks, as measured by the primary endpoint of the number of gout flares per patient over the 16 week treatment period.

9 Jun 2010

Interim results from PROPEL study of RG7128 submitted as abstract to AASLD for Annual Liver Meeting

Pharmasset, Inc. announced today that the interim results from the PROPEL study conducted by its partner Roche demonstrate that RG7128 triple combination therapy was safe and well tolerated. In that study, the safety profile of RG7128 (1000mg BID or 500mg BID), when administered for 8 or 12 weeks with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin), the standard of care, was similar to the safety profile of SOC alone.

9 Jun 2010

S*BIO completes enrollment in SB1518 JAK2 inhibitor Phase 2 clinical trials for myelofibrosis

S*BIO Pte Ltd today announced that it has completed enrollment of patients in two separate Phase 2 clinical trials for its potent and orally-active JAK2 inhibitor SB1518 at multiple clinical sites in the U.S. and Australia for the treatment of myelofibrosis (MF).

9 Jun 2010

Discovery Labs reports preliminary results from Surfaxin Phase 2 trial in children with Acute Respiratory Failure

Discovery Laboratories, Inc., reports preliminary results from its Phase 2 clinical trial of Surfaxin® in children with Acute Respiratory Failure (ARF), a critical condition often caused in children by severe respiratory infections. The objective of the study was to evaluate the safety and tolerability of intratracheal administration of Surfaxin and to assess whether Surfaxin treatment could decrease the duration of mechanical ventilation in children with ARF.

9 Jun 2010

Efficacy News and Research

FDA advisory committee recommends approval of Novartis' FTY720 for relapsing MS

EC approves Nivestim for prevention of FN

Onset Therapeutics expands sales force by over 50% in 2010

Boston Scientific's TAXUS Element Paclitaxel-Eluting Coronary Stent System launched in Europe

Neutralizing inhibitory molecules does not improve regeneration in damaged spinal axons

MAP Pharmaceuticals to present new analyses from LEVADEX Phase 3 trial for acute migraine at 52nd AHS

Preclinical data of VB-201 to be presented at EULAR Annual European Congress of Rheumatology

UC emergency medicine assistant professor compares efficacy of two seizure medications to prevent SE

Aeterna Zentaris reports final results on clinical activity of perifosine for metastatic colorectal cancer

Cognitive-behavioral, skills-based treatment intervention program shows promise for teenagers with IBD

Sialidase improves nerve regrowth, motor recovery and nervous system function: Researchers

TF2 bispecific antibody pretargeted therapy prolongs survival in animal model of human colonic cancer

CoLucid's lasmiditan NAAMA effective in treatment of acute migraine attacks

New information to help patients make important decision regarding stem cell treatments

NICE decides not to recommend lapatinib for women with advanced breast cancer

FDA approves Roxane Laboratories' Valacyclovir Hydrochloride Tablets ANDA

Regeneron's ARCALYST prevents gout attacks in Phase 3 study of patients initiating allopurinol therapy

Interim results from PROPEL study of RG7128 submitted as abstract to AASLD for Annual Liver Meeting

S*BIO completes enrollment in SB1518 JAK2 inhibitor Phase 2 clinical trials for myelofibrosis

Discovery Labs reports preliminary results from Surfaxin Phase 2 trial in children with Acute Respiratory Failure

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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