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Second-quarter fiscal 2009 results announced by Gentium

Gentium S.p.A. (NASDAQ: GENT) today reported financial results for the second quarter ended June 30, 2009.

17 Sep 2009

Study: Antiretroviral drugs may prevent HIV infection in women

Hopeful that some of the same antiretroviral (ARV) drugs used to treat HIV infection can also prevent it, researchers from the Microbicide Trials Network have enrolled the first participants into a new, large-scale clinical trial testing two approaches of the strategy in women.

17 Sep 2009

VOICE clinical study for testing the efficacy of two HIV prevention strategies

A new, large-scale clinical trial is examining whether antiretroviral medications normally used to treat HIV infection can also prevent HIV infection in women when applied as a vaginal gel or taken as oral tablets once daily.

16 Sep 2009

Rib-X and NIAID collaborate to develop an antibiotic treatment for N. gonorrhoeae

Rib-X Pharmaceuticals, Inc., a company focused on the discovery, development and commercialization of novel drugs for the treatment of multi-antibiotic resistant infections, today announced that it intends to enter into a Clinical Trials Agreement with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services.

15 Sep 2009

AzaSite production increased to combat erythromycin ophthalmic ointment shortage

InSite Vision Incorporated today announced that Inspire Pharmaceuticals, its commercial partner for AzaSite (azithromycin ophthalmic solution) 1% in the U.S and Canada, has committed to increasing production of AzaSite in response to the manufacturing supply shortage of erythromycin ophthalmic ointment (0.5%).

15 Sep 2009

Merck update on the status of telcagepant clinical development programs

Merck & Co., Inc. today updated the status of the clinical development programs for telcagepant (MK-0974) and MK-3207, the Company's investigational oral calcitonin gene-related peptide (CGRP) receptor antagonists for the intermittent treatment of acute migraine.

11 Sep 2009

GI Company's Phase II study demonstrates safety of rhITF oral spray formulation

Published today, as an original investigation, in the peer-reviewed Journal of Clinical Oncology, are statistically significant Phase II clinical results of The GI Company's lead clinical compound, rhITF (recombinant human Intestinal Trefoil Factor) oral spray. The article is titled, "A Phase II, Randomized, Double-blind, Placebo-Controlled Study of rhITF Oral Spray for Prevention of Oral Mucositis in Colorectal Cancer Patients Receiving 5-Fluorouracil-based Chemotherapy."

10 Sep 2009

St. Vincent develops the first-ever HIV educational widget

Saint Vincent Catholic Medical Centers and the New York State Department of Health (DOH) today unveiled a novel Web-based technology to rapidly instruct health care providers throughout New York State about HIV diagnosis and prevention.

10 Sep 2009

Inspire Pharmaceuticals to increase production of azithromycin ophthalmic solution

Inspire Pharmaceuticals, Inc. announced today that it has been communicating with the U.S. Food and Drug Administration (FDA) and is increasing its production of AzaSite® (azithromycin ophthalmic solution) 1% in response to the manufacturing supply shortage of erythromycin ophthalmic ointment (0.5%).

10 Sep 2009

Phase III trials for CS-8958 neuraminidase inhibitor successful

Hovione is pleased to announce that its TwinCaps(R) inhaler licensees Daiichi Sankyo Co. Ltd. (Tokyo, Japan) and Biota Holdings Ltd (Victoria, Australia) have both announced successful Phase III trials for CS-8958, a new long-acting neuraminidase inhibitor for treatment of influenza (known as a prodrug of laninamivir).

9 Sep 2009

rPA anthrax vaccine and its Valortim anthrax anti-toxin program data presented

PharmAthene, Inc., a biodefense company developing medical countermeasures against biological and chemical threats, announced today that data from the Company's third generation recombinant protective antigen (rPA) anthrax vaccine program and its Valortim((R)) anthrax anti-toxin program were presented at the Bacillus - ACT 2009 meeting, August 30 - September 3, 2009, organized by the American Society for Microbiology.

4 Sep 2009

Sheller, P.C helps to settle the largest whistleblower complaint

Pfizer Inc. ignored a 2005 FDA Warning Letter to stop promoting its antibiotic Zyvox(R) as clinically superior to the significantly less expensive, generic vancomycin when its own FDA-approved label indicated otherwise. The drug giant also defrauded federal and state taxpayers by marketing Zyvox off-label, according to a qui tam whistleblower complaint filed by Philadelphia law firm Sheller, P.C. and other documents unsealed with today's $2.3 billion Pfizer settlement.

3 Sep 2009

Pathogenic microbes can suppress immune system in newborns

Group B Streptococcus (GBS), a bacterial pathogen that causes sepsis and meningitis in newborn infants, is able to shut down immune cell function in order to promote its own survival, according to researchers at the University of California, San Diego School of Medicine and the Skaggs School of Pharmacy and Pharmaceutical Sciences.

2 Sep 2009

Cimzia approved for treating adult patients with rheumatoid arthritis

UCB Canada Inc. announced today that Health Canada has approved Cimzia, the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

1 Sep 2009

Thrombogenics issues business update and half year results

ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer, is today issuing a business update and its half year results for the six month period ending 30 June, 2009.

28 Aug 2009

New rule from CMS for improving stroke patient care in hospitals

A new rule from the U.S. Centers for Medicare and Medicaid Services (CMS Final FY 2010 Rule) focuses on improving stroke patient care in hospitals. Beginning 2010, hospitals submitting Medicare claims for stroke must let CMS know if they participate in a database registry for stroke care, such as that maintained by the American Heart Association/American Stroke Association's Get With The Guidelines-Stroke (GWTG-Stroke) quality improvement initiative.

28 Aug 2009

Prevention and eradication of FVIII antibodies could improve hemophilia treatment

Octapharma AG is leading an international initiative focused on confronting the major risk associated with hemophilia A therapy - anti-factor VIII (FVIII) antibodies, also known as inhibitors. This initiative, combined with Octapharma's efforts to pursue the first recombinant FVIII therapy produced from a human cell line, could dramatically impact the treatment of an estimated one in every 5,000 to 10,000 men born with hemophilia A worldwide.

27 Aug 2009

Hiberix receives accelerated approval from FDA to overcome nationwide shortage

The U.S. Food and Drug Administration today approved Hiberix, a Haemophilus influenzae Type b (Hib) vaccine, as a booster dose for children 15 months through 4 years old. Hiberix is manufactured by GlaxoSmithKline, with U.S. headquarters in Research Triangle Park, N.C. and Philadelphia.

26 Aug 2009

FDA issues marketing approval for APP Pharmaceuticals' Penicillin G potassium for Injection, USP

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc. (NASDAQ: APCVZ), announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market penicillin G potassium for Injection, USP, in two dosage strengths. Penicillin G is therapeutically equivalent to the reference drug PfizerPen™ G, which is marketed by the innovator Pfizer, Inc.

25 Aug 2009

NIAID funds Nanotherapeutic for developing an inhaled version of the injectable antiviral drug

Nanotherapeutics, Inc., today announced that it has been awarded a $30.9 Million, 5-year contract from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to develop an inhaled version of the injectable antiviral drug, cidofovir, for non-invasive, post-exposure prophylaxis and treatment of the Category A bioterrorism agent smallpox (Variola major).

25 Aug 2009