Efficacy News and Research

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Phase III studies of EXPAREL (DepoBupivacaine) from Pacira complete enrollment

Pacira Pharmaceuticals, Inc., an acute care specialty pharmaceutical company, announced today that enrollment has been completed in two pivotal Phase III SIMPLE trials to evaluate the safety and efficacy of a single intraoperative administration of EXPAREL(TM) (DepoBupivacaine) for prolonged postoperative analgesia.

6 Jan 2009

Nicotine gum effective for gradual smoking reduction and cessation

Nicotine gum has been in use for over 20 years to help smokers quit abruptly yet close to two-thirds of smokers report that they would prefer to quit gradually.

6 Jan 2009

Pneumococcal polysaccharide vaccines do not appear to protect against pneumonia

Commonly used pneumococcal polysaccharide vaccines do not appear to be effective for preventing pneumonia, found a study by a team of researchers from Switzerland and the United Kingdom.

5 Jan 2009

Phase 3 trial begins for Gammagard liquid plus rHuPH20 in primary immunodeficiency patients

Baxter International Inc. and Halozyme Therapeutics, Inc. gas announced the start of a Phase 3 clinical trial of Baxter's Gammagard Liquid [Immune Globulin Intravenous] 10% (IGIV), marketed as KIOVIG in the European Union, with Halozyme's recombinant human hyaluronidase enzyme (rHuPH20, Enhanze Technology) for the treatment of primary immunodeficiency (PID).

From Baxter International Inc. 5 Jan 2009

Metadherin gene plays dual role in breast cancers with poor prognosis

A new study reveals that the metadherin gene (MTDH) plays a role in both cancer metastasis and resistance to chemotherapy.

5 Jan 2009

New technique for creating authentic embryonic stem cells from rats

Stem Cell Sciences plc has announced that pioneering research describing a technique for creating authentic embryonic stem (ES) cells from rats has been published in the prestigious peer-reviewed journal, Cell.

30 Dec 2008

Pegloticase BLA filing accepted for priority review by FDA

Savient Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's Biologics License Application (BLA) for pegloticase, a novel biological drug for treatment-failure gout (TFG) patients.

30 Dec 2008

FDA issues complete response letter to Ipsen for Dysport BLA

Ipsen has announced that the US Food and Drug Administration (FDA) issued a Complete Response Letter for its Biologics License Application (BLA) for its Botulinum toxin Type A, Dysport.

30 Dec 2008

Scientists reverse brain birth defects using stem cell therapy

Scientists at the Hebrew University of Jerusalem have succeeded in reversing brain birth defects in animal models, using stem cells to replace defective brain cells.

29 Dec 2008

FDA approves injectable drug degarelix for advanced prostate cancer

The U.S. Food and Drug Administration recently approved the injectable drug degarelix, the first new drug in several years for prostate cancer.

29 Dec 2008

Trial looks at high intensity focused ultrasound for locally recurrent prostate cancer

A Phase III clinical trial at New York University is investigating the safety and efficacy of High Intensity Focused Ultrasound (HIFU) for the treatment of locally recurrent prostate cancer following failed external beam radiation therapy (EBRT) using the Sonablate(R) 500.

22 Dec 2008

GlaxoSmithKline ready to supply Biota's Relenza to meet CDC recommendations

GlaxoSmithKline (GSK) is prepared to respond to public health needs for Relenza (zanamivir) Inhalation Powder this flu season following a Health Alert Advisory issued by the Centers for Disease Control and Prevention (CDC).

21 Dec 2008

FDA issues complete response to biologics license application for ustekinumab

Centocor, Inc., has announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter for its Biologics License Application (BLA) for ustekinumab.

21 Dec 2008

FDA approves Gleevec (imatinib mesylate) to prevent gastrointestinal stromal tumor

The U.S. Food and Drug Administration has approved Gleevec (imatinib mesylate) for a new indication – keeping cancer from growing in patients following surgical removal of a gastrointestinal stromal tumor or GIST.

21 Dec 2008

VistaGen, WARF sign license agreement for human embryonic stem cell technology

VistaGen Therapeutics and the Wisconsin Alumni Research Foundation (WARF) have signed a license for human embryonic stem cell patents for the development and commercialization of stem cell-based research tools.

18 Dec 2008

Prozac enhances effectiveness of anti-cancer drug

Prozac is regularly prescribed to ease the emotional pain of patients who are being treated for cancer.

18 Dec 2008

How cancer cells ensure their survival

A team of researchers headed by Professor Roland Stauber of Mainz University's ENT clinic has identified a molecular mechanism used by cancer cells to "defend" themselves against chemotherapeutics in an attempt to ensure their own survival.

17 Dec 2008

Male circumcision may help prevent human papillomavirus infection

Two new studies suggest that male circumcision may assist in the prevention of human papillomavirus (HPV) infection, particularly infection with the high-risk subtypes associated with cervical, penile, and other cancers.

17 Dec 2008

Biopure submits IND for trial in patients with acute myeloid leukemia

Biopure Corporation has announced that it has submitted to the Food and Drug Administration (FDA) an investigational new drug (IND) application to conduct a pilot phase 2 clinical trial of the company's oxygen therapeutic Hemopure [hemoglobin glutamer - 250 (bovine)].

17 Dec 2008

Abbott starts trial of 2.25 mm stent system

Abbott has announced the start of SPIRIT Small Vessel, a clinical trial evaluating a 2.25 mm size of the XIENCE V Everolimus Eluting Coronary Stent System.

17 Dec 2008