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Pfizer to withdraw global marketing applications for Dalbavancin to conduct a new trial

Pfizer Inc today announced it will globally withdraw all dalbavancin marketing applications for the treatment of complicated skin and skin structure infections in adults, including the U.S. new drug application (NDA) and the European marketing authorization application (MAA).

9 Sep 2008

Vitamin may protect the ageing brain from memory loss

Scientists in Britain are suggesting that a vitamin found in meat, fish and milk, may offer protection against memory loss in older people.

9 Sep 2008

Vaginal rings provide new HIV protection for women

Vaginal rings, similar to those used for contraception and hormone replacement therapy, could protect women from sexually-transmitted HIV, according to research presented at the British Pharmaceutical Conference (BPC) in Manchester.

8 Sep 2008

Trastuzumab-DM1 - a 'smart bomb' for breast cancer treatment

Sarah Cannon Research Institute (SCRI) investigators have found that "smart bomb" therapies are effective in treating breast cancer patients while minimizing side effects.

7 Sep 2008

African countries commit to new meningitis vaccine

Health ministers from countries of the African meningitis belt today committed themselves to introduce a highly promising candidate meningitis vaccine. The vaccine is designed to prevent periodic epidemics of the deadly disease in these countries.

4 Sep 2008

Nanotherapeutics files INDA for NanoDOX hydrogel to treat type of diabetic ulcers

Nanotherapeutics announced today that it has submitted its first Investigational New Drug (IND) application to the FDA for a phase IIa clinical study for its product NanoDOX Hydrogel, a topical doxycycline hydrogel for chronic wounds.

4 Sep 2008

FDA 'fast track' granted to BioMS Medical for lead drug, dirucotide for the treatment of multiple sclerosis

BioMS Medical Corp has announced that the Food and Drug Administration (FDA) of the United States has granted fast track designation for the Company's lead drug, dirucotide (MBP8298), for the treatment of secondary progressive MS (SPMS). Dirucotide (MBP8298) is currently being evaluated in a U.S. pivotal phase III trial, named MAESTRO-03, at 68 sites with approximately 510 patients.

4 Sep 2008

Anadis to commercialise "BioGard" adjunctive therapy for HIV/AIDS

Anadis announced today its commercialization of a new product, BioGard, intended to maintain gastrointestinal and immune system health. The specific formulation may be of particular clinical benefit in persons undergoing antiretroviral therapy for HIV/AIDS.

4 Sep 2008

Second phase 3 trial of Bronchitol in cystic fibrosis sufferers begins

Pharmaceutical company Pharmaxis today announced that it has enrolled the first subject into its second pivotal Phase 3 clinical trial evaluating Bronchitol in cystic fibrosis sufferers.

4 Sep 2008

Clinical trial advances cystic fibrosis therapy

Axentis Pharma AG has initiated a clinical phase IIa trial to assess the safety and tolerability of a new therapeutic formulation for the treatment of severe pulmonary infection in cystic fibrosis patients. The new formulation allows an established therapeutic agent to be delivered directly to the site of infection. The forthcoming trial will also compare the effects of two different doses of the new drug.

4 Sep 2008

Diffusion Pharmaceuticals initiates phase I/II clinical trial in patients with peripheral arterial disease

Diffusion Pharmaceuticals LLC, a clinical-stage drug-development company commercializing new drugs for the treatment of unmet medical needs, announced today that it has begun to enroll patients in a Phase I/II clinical trial of its lead drug candidate trans sodium crocetinate (TSC).

3 Sep 2008

Vimpat (lacosamide) approved in Europe

UCB announced today that the European Commission (EC) has approved Vimpat (lacosamide) as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. Vimpat is the first new antiepileptic drug (AED) for partial-onset seizures in three years and offers a new treatment option for European patients living with uncontrolled partial-onset epilepsy.

3 Sep 2008

Further analysis from ATHENA study showed Multaq (Dronedarone) reduced risk of stroke in patients with atrial fibrillation

The results of a post-hoc analysis of the data from the ATHENA study were presented today at the clinical trial update session of the European Society of Cardiology congress 2008, in Munich, Germany.

3 Sep 2008

FDA authorizes INDA for recombinant human C1 inhibitor in kidney transplantation

Biotech company Pharming Group NV has announced that the US Food and Drug Administration (FDA) has authorized a clinical study with recombinant human C1 inhibitor (rhC1INH) for the treatment of antibody-mediated rejection (AMR) in kidney transplantation. Dr. Hans Sollinger of the University of Wisconsin, Madison will conduct the clinical trial with rhC1INH under an Investigator IND from the FDA.

3 Sep 2008

New hope for treating common form of inherited neuromuscular disease

Treatments that ramp up production of the tiny "motors" that power cells may have promise for treating one of the most common forms of inherited neuromuscular disease, according to a report in the September Cell Metabolism, a Cell Press publication. Neuromuscular disorders caused by defects in those mitochondrial motors affect a large number of children and adults worldwide, but today remain without treatment, the researchers said.

3 Sep 2008

Anadis Ltd's clinical trial against mucositis approved in Israel

Anadis Ltd., an Australian biopharmaceutical company specializing in oral immunotherapy using naturally derived antibodies and other proteins is announcing the clinical protocol for its Cancer-related Mucositis Program was cleared by the Tel Aviv Souraski Medical Center's Institutional Review Board (IRB) and by the Israeli Ministry of Health (MOH).

3 Sep 2008

Spinifex secures major investment to develop pain drug

Spinifex Pharmaceuticals, an Australian pain drug development company, today announced it has secured venture capital investment of A$12 million from GBS Venture Partners Limited, Brandon Capital Partners and Uniseed to fund the development of its pain management drug, EMA401.

2 Sep 2008

Fibrex medical reports positive phase II results for peptide for the treatment of reperfusion injury

Fibrex Medical has announced positive Phase II results for FX06, a peptide for the treatment of reperfusion injury - the damage to heart muscle that results from remedial treatment following a heart attack. The results will be presented at the ESC Congress today in Munich, Germany.

2 Sep 2008

Fibrin-derived peptide FX06 reduces cardiac reperfusion injury

Data presented today at the European Society of Cardiology Congress demonstrates the effectiveness of a peptide called FX06 in preventing cardiac damage resulting from treatment following a heart attack.

2 Sep 2008

Results from the Simvastatin and Ezetimibe in aortic stenosis study

The SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) study has investigated the effects of intensive cholesterol lowering with the combination of simvastatin (40 mg daily) and ezetimibe (10 mg daily) in patients with aortic stenosis.

2 Sep 2008