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No increased cardiovascular risk seen in elderly patients taking Celebrex

The National Institutes of Health has reported in an Alzheimer's Disease prevention study that there was no increased cardiovascular risk seen in elderly patients taking Celebrex (400 mg daily) for up to three years.

21 Dec 2004

New advice on anti-inflammatory drugs called Cox-2 Inhibitors, including Celebrex

Patients who are taking Celebrex, Bextra and Arcoxia should make a non-urgent appointment with their GP to review their treatment. Patients who have established heart disease or who are at high risk of stroke will have their treatment changed.

21 Dec 2004

FDA issues advice on Naproxen

The FDA has released the following statement on NIH halting a clinical trial involving non-steroidal anti-inflammatory drugs in patients at risk of developing Alzheimer's Disease:

20 Dec 2004

Genzyme files for European approval of Myozyme for treatment of Pompe disease

Genzyme Corp. announced today that the European Medicines Agency (EMEA) has accepted its marketing authorization application for Myozyme(R) (alglucosidase alfa), an investigational enzyme replacement therapy for Pompe disease.

20 Dec 2004

Genetic markers implicated in fatal side effects of schizophrenia drug

Genaissance Pharmaceuticals today announced results from its CARING (Clozapine and Agranulocytosis Relationships Investigated by Genetics) study, reporting the discovery of genetic markers that the Company believes predict who is at risk of developing clozapine-induced agranulocytosis

20 Dec 2004

Advice for patients who have been taking Celebrex or Bextra

The recent announcement that Celebrex, a popular pain drug in the same family as Vioxx, has been found to pose an increased risk of heart problems is bound to leave many pain patients stunned, confused and worried.

20 Dec 2004

Potential safety risks with Celebrex

The Australian Therapeutic Goods Administration (TGA) has consulted today with the Chairs of its peak advisory committees, the Australian Adverse Drug Reactions Committee (ADRAC) and the Australian Drug Evaluation Committee (ADEC), about the latest research into the safety of the arthritis drug, Celebrex.

20 Dec 2004

Tentative approval for Topiramate Tablets

Ranbaxy Pharmaceuticals announced tentative approval from the U.S. Food and Drug Administration to manufacture and market Topiramate Tablets, 25 mg, 100 mg, and 200 mg. Total annual market sales for Topiramate were $1,184 million with sales of these three strengths of tablets totaling $1,129 million.

20 Dec 2004

Macugen approved for the treatment of neovascular (wet) age-related macular degeneration (AMD)

Eyetech Pharmaceuticals and Pfizer have announced that the U.S. Food and Drug Administration (FDA) approved Macugen (pegaptanib sodium injection) for the treatment of neovascular (wet) age-related macular degeneration (AMD), an eye disease associated with aging that destroys central vision.

20 Dec 2004

Celebrex suspension

The National Institutes of Health (NIH) announced that it has suspended the use of COX-2 inhibitor celecoxib (Celebrex™ Pfizer, Inc.) for all participants in a large colorectal cancer prevention clinical trial conducted by the National Cancer Institute (NCI).

19 Dec 2004

Obesity drug codenamed AOD9604 highly successful in trials

An Australian-owned obesity drug, developed by Melbourne-based biotechnology company Metabolic Pharmaceuticals Limited, is set to enter final human trials next year after successfully completing a Phase 2b human trial which proved that the drug induces weight loss and is very well tolerated with no evidence of the side effects commonly experienced with existing obesity drugs.

16 Dec 2004

Scientists have identified a novel anti-tuberculosis (TB) compound

Scientists at Johnson & Johnson Pharmaceutical Research and Development have identified a novel anti-tuberculosis (TB) compound that works better and faster than the current standard of care in mouse models of TB infection.

14 Dec 2004

GlaxoSmithKline acquires full marketing and development rights for BEXXAR worldwide

GlaxoSmithKline announced that it has reached an agreement with Corixa Corporation to acquire worldwide rights and responsibilities related to the manufacturing, development and commercialization of the BEXXAR® therapeutic regimen.

14 Dec 2004

Safety of AIDS drug to prevent mother-to-child transmission of HIV questioned

In light of several recent drug industry scandals roiling the nation's public health and raising serious questions about the US bodies that license and regulate the industry -- and startling new revelations today concerning National Institutes of Health (NIH) officials and the safety of a brand name AIDS drug used to prevent mother-to-child transmission of the HIV

14 Dec 2004

Detrol LA significantly reduces symptoms of overactive bladder

Pfizer today announced results of a comprehensive six-year review of efficacy and safety data for Detrol LA (tolterodine tartrate extended release capsules) indicating that Detrol LA significantly reduces symptoms of overactive bladder (OAB) with a low occurrence of side effects, and should be considered first-line therapy.

13 Dec 2004

Successful human trial of obesity drug that mimicks metabolic effects of growth hormone

The AOD9604 molecule is a small orally active peptide modelled on one section of the human growth hormone molecule. Growth hormone naturally occurs in the body and has profound stimulatory effects on fat metabolism, with levels of the hormone typically becoming suppressed in the obese state.

13 Dec 2004

FDA accepts Genmab's Investigational New Drug Application for active rheumatoid arthritis treatment

Genmab announced today the US Food and Drug Administration (FDA) accepted its Investigational New Drug Application (IND) to start a Phase I/II dose escalation trial for HuMax-CD20 to treat patients with active rheumatoid arthritis (RA) who have failed one treatment with one or more disease modifying anti-rheumatic drugs (DMARDs).

13 Dec 2004

Pharmaceutical, biotechnology and drug discovery companies are increasingly turning their attention to cell-based assays

Pharmaceutical, biotechnology and drug discovery companies are increasingly turning their attention to cell-based assays, as these assays offer a more accurate representation of the real-life cell model than the traditional enzyme- or antibody-based assays.

13 Dec 2004

FDA approves Topigen's investigational New Drug Application for new inhalation drug to treat asthma

Phase 1 clinical trial can be initiated for ASM8, a new inhalation drug that is designed to treat asthma through a unique approach by attacking multiple mediators of the inflammatory mechanism rather than the single mediator approach of current therapies.

8 Dec 2004

Lilly launches publicly available clinical trial registry

Eli Lilly and Company today will announce the launch of its publicly available clinical trial registry, www.lillytrials.com, which will post the results from all Phase I through Phase IV clinical trials of Lilly's marketed products.

8 Dec 2004

Pharmaceutical News

No increased cardiovascular risk seen in elderly patients taking Celebrex

New advice on anti-inflammatory drugs called Cox-2 Inhibitors, including Celebrex

FDA issues advice on Naproxen

Genzyme files for European approval of Myozyme for treatment of Pompe disease

Genetic markers implicated in fatal side effects of schizophrenia drug

Advice for patients who have been taking Celebrex or Bextra

Potential safety risks with Celebrex

Tentative approval for Topiramate Tablets

Macugen approved for the treatment of neovascular (wet) age-related macular degeneration (AMD)

Celebrex suspension

Obesity drug codenamed AOD9604 highly successful in trials

Scientists have identified a novel anti-tuberculosis (TB) compound

GlaxoSmithKline acquires full marketing and development rights for BEXXAR worldwide

Safety of AIDS drug to prevent mother-to-child transmission of HIV questioned

Detrol LA significantly reduces symptoms of overactive bladder

Successful human trial of obesity drug that mimicks metabolic effects of growth hormone

FDA accepts Genmab's Investigational New Drug Application for active rheumatoid arthritis treatment

Pharmaceutical, biotechnology and drug discovery companies are increasingly turning their attention to cell-based assays

FDA approves Topigen's investigational New Drug Application for new inhalation drug to treat asthma

Lilly launches publicly available clinical trial registry

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