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Clinical trials to test the safety of a first-of-its-kind human hookworm vaccine

Clinical trials to test the safety of a first-of-its-kind human hookworm vaccine will begin in the Washington, DC area in a couple of months after the U.S. Food and Drug Administration conferred investigational new drug status on the vaccine.

27 Jan 2005

Enbrel to treat rheumatoid arthritis approved in Japan

Wyeth K.K. and Takeda Pharmaceutical Company Limited (Takeda) have announced that Enbrel (etanercept) has been approved by the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of rheumatoid arthritis (RA) in patients who had an inadequate response to existing therapies.

27 Jan 2005

$Phenoxodiol gets fast track status for its intended use in patients with hormone-refractory prostate cancer$

Phenoxodiol gets fast track status for its intended use in patients with hormone-refractory prostate cancer

Marshall Edwards today announced that the U.S. Food and Drug Administration (FDA) has granted the investigational anti-cancer drug, phenoxodiol, fast track status for its intended use in patients with hormone- refractory prostate cancer (HRPC).

26 Jan 2005

Tentative approval of co-packaged lamivudine/zidovudine fixed dose combination tablets and nevirapine tablets

The Food and Drug Administration (FDA) has announced the tentative approval of a co-packaged antiretroviral drug regimen manufactured by Aspen Pharmacare of South Africa for the treatment of HIV-1 infection in adults.

26 Jan 2005

Schering and Novartis agree on joint commercialization of novel cancer drug

Schering AG, Germany announced today that, following regulatory approvals, it will co-promote the novel oral angiogenesis inhibitor PTK787/ZK 222584 (PTK/ZK) for all oncology indications together with Novartis Pharma AG in Europe, North America and Japan. This agreement will enable both Schering and Novartis to maximize the compound's full potential.

25 Jan 2005

Monoclonal antibody therapeutics to fill vacuum left by ineffective conventional therapies

Currently, the limited efficacy of conventional therapies, especially in the case of several oncology and autoimmune and inflammatory disorders (AIID), is creating the need for safe and effective treatment alternatives.

25 Jan 2005

Launch date announced for Abraxane to treat metastatic breast cancer

American Pharmaceutical Partners announced today that February 8, 2005 is the launch date of Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound). Abraxane will be marketed by the national sales force of Abraxis Oncology, APP's proprietary sales and marketing division.

25 Jan 2005

Vioxx withdrawal raises many questions concerning drug policy

Daniel H. Solomon, M.D., M.P.H., from Brigham and Women’s Hospital, Boston, and Jerry Avorn, M.D., of Harvard University School of Medicine, write in the January 24 issue of Archives of Internal Medicine that the withdrawal of rofecoxib (Vioxx) from the market in September 2004 by its manufacturer, Merck & Co., “raises many questions concerning drug policy, scientific evidence, and treatment alternatives.

24 Jan 2005

Phenoxodiol increases the effectiveness of Docetaxel by at least 100 times

The investigational anti- cancer drug, phenoxodiol, considerably enhances the ability of the drug, docetaxel (Taxotere(R), Sanofi-Aventis), to kill human ovarian cancer cells in the laboratory. The findings are reported in the current issue of Oncology Research.

24 Jan 2005

Orally ingested drug to help Type 2 diabetes sufferers

A new drug invented by Monash University researchers Paul Zimmet and Frank Ng could help Type 2 diabetes sufferers lower blood glucose levels and enhance the potency of insulin, with few side effects.

24 Jan 2005

Organon’s compound, Org 24448, selected to test efficacy of cognitive dysfunction in schizophrenia

The National Institute of Mental Health (NIMH) sponsored network called Treatment Units for Research on Neurocognition in Schizophrenia (TURNS) has selected Organon’s compound, Org 24448, to undergo testing as part of its effort to facilitate the development of medications to enhance cognition in patients with schizophrenia.

24 Jan 2005

Call for Anastrozole (Arimidex) to be the new preferred breast cancer treatment option

An international group of breast cancer experts called for the aromatase inhibitor (AI), anastrozole ('Arimidex'), to be considered as the new 'preferred treatment option' for postmenopausal women with early breast cancer.

24 Jan 2005

Health authorities reviewing scientific data from trials evaluating Alzheimer's treatment, Reminyl

Johnson & Johnson Pharmaceutical Research & Development, LLC (J&JPRD) announced that health authorities are reviewing scientific data from two clinical trials evaluating an investigational use of the company's Alzheimer's treatment, Reminyl (galantamine hydrobromide), in individuals with mild cognitive impairment.

24 Jan 2005

Serono completes enrollment in phase III trial of Serostim

Serono has announced that it has completed enrollment in its second multi-center, phase III trial of Serostim (somatropin [rDNA origin] for injection) in the treatment of HIV-Associated Adipose Redistribution Syndrome (HARS).

24 Jan 2005

ID Biomedical begins development of pandemic influenza vaccine

ID Biomedical announced today that it has begun development of an experimental ("mock") vaccine against a strain of the influenza virus, H5N1, that experts believe could cause a deadly worldwide epidemic (pandemic) of influenza.

19 Jan 2005

NIH begins Phase 1 clinical trial of HIV vaccine candidate

GenVec announced today that the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), has begun the second Phase 1 clinical trial in healthy adult volunteers of an HIV vaccine candidate jointly developed by the Dale and Betty Bumpers Vaccine Research Center (VRC), a part of NIAID, and GenVec.

19 Jan 2005

FDA knocks back anticancer drug Marqibo

Inex Pharmaceuticals announced today that United States Food and Drug Administration (FDA) provided an action letter detailing that the anticancer drug Marqibo (vincristine sulfate liposomes injection) is "not approvable" under the FDA's accelerated approval regulations based on the phase 2 clinical trial data submitted.

19 Jan 2005

Measures to improve the drug side effect reporting system - the Yellow Card Scheme

Patients and researchers will be able to look at data on the safety of different medicines announced Health Minister, Lord Warner today. The move is part of a series of measures to further improve the drug side effect reporting system - the Yellow Card Scheme, which is used by the medicines watchdog (MHRA) to monitor the safety of medicines in the UK.

17 Jan 2005

No to over the counter statin!

Last Friday an FDA expert panel voted overwhelmingly against the over-the-counter sale of Merck's cholesterol lowering drug Mevacor (lovastatin). Mevacor is one of a number of drugs known as "statins" which are widely considered to be the most effective drugs for the treatment of high cholesterol. Statins work by inhibiting a liver enzyme used in the manufacture of cholesterol.

17 Jan 2005

Alvesco now available for asthma sufferers in the United Kingdom

Altana AG has announced that Alvesco (Ciclesonide), a novel inhaled corticosteroid (ICS) for the treatment of adults (18+ years) suffering from persistent asthma is now available for the first time in the United Kingdom (UK).

17 Jan 2005

Pharmaceutical News

Clinical trials to test the safety of a first-of-its-kind human hookworm vaccine

Enbrel to treat rheumatoid arthritis approved in Japan

Phenoxodiol gets fast track status for its intended use in patients with hormone-refractory prostate cancer

Tentative approval of co-packaged lamivudine/zidovudine fixed dose combination tablets and nevirapine tablets

Schering and Novartis agree on joint commercialization of novel cancer drug

Monoclonal antibody therapeutics to fill vacuum left by ineffective conventional therapies

Launch date announced for Abraxane to treat metastatic breast cancer

Vioxx withdrawal raises many questions concerning drug policy

Phenoxodiol increases the effectiveness of Docetaxel by at least 100 times

Orally ingested drug to help Type 2 diabetes sufferers

Organon’s compound, Org 24448, selected to test efficacy of cognitive dysfunction in schizophrenia

Call for Anastrozole (Arimidex) to be the new preferred breast cancer treatment option

Health authorities reviewing scientific data from trials evaluating Alzheimer's treatment, Reminyl

Serono completes enrollment in phase III trial of Serostim

ID Biomedical begins development of pandemic influenza vaccine

NIH begins Phase 1 clinical trial of HIV vaccine candidate

FDA knocks back anticancer drug Marqibo

Measures to improve the drug side effect reporting system - the Yellow Card Scheme

No to over the counter statin!

Alvesco now available for asthma sufferers in the United Kingdom

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