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EMEA statement following withdrawal of Vioxx (rofecoxib)

EU regulators met with the marketing authorisation holder of Vioxx (rofecoxib), Merck Sharp & Dohme, on 4-5 October 2004 at the informal meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) held in Scheveningen, The Netherlands.

6 Oct 2004

Ireland's Department of Health has resolved outstanding concerns over the availability of flu vaccines

The Ireland's Department of Health has resolved outstanding concerns over the availability of flu vaccines and has secured commitments from new suppliers that will fully meet Ireland’s needs this winter.

5 Oct 2004

U.S. healthcare industry reaction to the withdrawal of Vioxx from the world-wide market

NDCHealth has announced U.S. healthcare industry reaction to the Sept. 30 announcement by Merck & Co. that it was withdrawing its anti-arthritic medication Vioxx from the world-wide market.

5 Oct 2004

U.S. Department of Health and Human Services responds to loss of Chiron flu vaccine

Clearly, the loss of the Chiron flu vaccine poses a serious challenge to our vaccine supply for the upcoming flu season. Chiron was to produce between 46-48 million doses of influenza vaccine for the United States.

5 Oct 2004

RiboNovix secures license to novel anti-infective discovery technology from Wayne State University

New biotechnology company, RiboNovix, Inc., is addressing the worsening problem of antibiotic-resistant bacteria by developing new anti-infectives that are less susceptible to drug resistance.

5 Oct 2004

Natural alternatives to osteoarthritis drug

The recall of Vioxx should come as a major sign of the need to look for safer alternatives for osteoarthritis treatment, according to the Director of the Australian Centre for complementary Medicine Education and Research (ACCMER), Professor Stephen Myers.

5 Oct 2004

Teva Pharmaceuticals granted final approval for Ribavirin capsules

Teva Pharmaceutical Industries has announced that the U.S. Food and Drug Administration has granted final approval for the Company’s ANDA for Ribavirin Capsules, 200 mg. Shipment of this product is expected to begin immediately.

5 Oct 2004

A trial of beta-interferon-1a in inclusion-body myositis has failed to find benefit from the drug in this disease

A trial of beta-interferon-1a in inclusion-body myositis (IBM) has failed to find benefit from the drug in this disease. Beta-interferons counteract some of the activities of the immune system, which some experts believe is misguided in IBM.

5 Oct 2004

$Analysis shows Teriparatide reduces fracture risk independent of bone turnover$

Analysis shows Teriparatide reduces fracture risk independent of bone turnover

Data presented yesterday at the 26th annual meeting of the American Society for Bone and Mineral Research (ASBMR) show that the ability of teriparatide to prevent fractures remained consistent regardless of pretreatment bone turnover status.

5 Oct 2004

Immediate voluntary world-wide withdrawal of Vioxx (rofecoxib)

Pharmaceutical company, Merck Sharp & Dohme has announced an immediate voluntary world-wide withdrawal of the drug, Vioxx (rofecoxib), commonly used for patients with rheumatoid or osteoarthritis.

4 Oct 2004

FDA fast tracks Genaera's drug for the treatment of wet age-related macular degeneration

Genaera Corporation has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to squalamine, an intravenously administered, first in class, small molecule anti-angiogenic drug for the treatment of "wet" age-related macular degeneration (AMD).

4 Oct 2004

First U.S. program to allow citizens to purchase lower cost, safe prescription drugs from Europe and Canada

Illinois Gov. Rod R. Blagojevich and Congressman Rahm Emanuel (D-Chicago) were joined in Chicago today by Wisconsin Governor Jim Doyle to launch the new I-SaveRx prescription drug importation program -- the first program in the nation to allow citizens to purchase lower cost, safe prescription drugs from Europe and Canada.

4 Oct 2004

Bristol-Myers Squibb submits New Drug Application to the U.S. Food and Drug Administration for entecavir

Bristol-Myers Squibb has announced the submission of a New Drug Application to the U.S. Food and Drug Administration for entecavir, an investigational antiviral agent under development for the treatment of chronic Hepatitis B.

4 Oct 2004

MHRA advice following withdrawal of Vioxx (rofecoxib)

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued advice following the withdrawal of a widely-used pain-killer and anti-inflammatory drug Vioxx (rofecoxib).

4 Oct 2004

Chiron grants a non-exclusive license to the German Red Cross

Chiron Corporation has announced that it has granted a non-exclusive license to the Blood Transfusion Centers of the German Red Cross (Blutspendediensten des Deutsche Rotes Kreuz, or DRK) for use of the company's HIV-1 and hepatitis C virus (HCV) technology for use in molecular probe "home brew" blood screening.

4 Oct 2004

Data demonstrate that Celebrex does not increase the risk of heart attack or stroke in patients with arthritis and pain

Pfizer has said that three large long-term Celebrex (celecoxib capsules) studies involving more than 6,000 patients have not shown any significant safety issues and are expected to continue to completion.

4 Oct 2004

Approval of Abilify (aripiprazole) for the treatment of acute bipolar mania

Bristol-Myers Squibb and Otsuka Pharmaceutical have announced that the U.S. Food and Drug Administration (FDA) has approved Abilify (aripiprazole) for the treatment of acute bipolar mania, including manic and mixed episodes associated with bipolar disorder.

4 Oct 2004

Pharmaceutical News

EMEA statement following withdrawal of Vioxx (rofecoxib)

Ireland's Department of Health has resolved outstanding concerns over the availability of flu vaccines

U.S. healthcare industry reaction to the withdrawal of Vioxx from the world-wide market

U.S. Department of Health and Human Services responds to loss of Chiron flu vaccine

RiboNovix secures license to novel anti-infective discovery technology from Wayne State University

Natural alternatives to osteoarthritis drug

Teva Pharmaceuticals granted final approval for Ribavirin capsules

A trial of beta-interferon-1a in inclusion-body myositis has failed to find benefit from the drug in this disease

Analysis shows Teriparatide reduces fracture risk independent of bone turnover

Immediate voluntary world-wide withdrawal of Vioxx (rofecoxib)

FDA fast tracks Genaera's drug for the treatment of wet age-related macular degeneration

First U.S. program to allow citizens to purchase lower cost, safe prescription drugs from Europe and Canada

Bristol-Myers Squibb submits New Drug Application to the U.S. Food and Drug Administration for entecavir

MHRA advice following withdrawal of Vioxx (rofecoxib)

Chiron grants a non-exclusive license to the German Red Cross

Data demonstrate that Celebrex does not increase the risk of heart attack or stroke in patients with arthritis and pain

Approval of Abilify (aripiprazole) for the treatment of acute bipolar mania

Australian nanotech Starpharma to develop a second generation microbicide for the prevention of infection by HIV

ID Biomedical awarded US$9.5 million to develop its cell culture-based influenza vaccine

Biomira and Merck announce fast track status for liposome vaccine

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