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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

Biopharmaceutical market generated revenues of USD 45.0 billion in 2004

New analysis from Frost & Sullivan, Strategic Analysis of the World Plant Molecular Farming Market, reveals that the biopharmaceutical market generated revenues of USD 45.0 billion in 2004. It is likely to reach USD 98.2 billion by 2011.

17 Jan 2005

FDA licenses Sanofi pasteur vaccine for protection against meningococcal disease

Sanofi pasteur, the vaccines business of the sanofi-aventis Group, announced today that the U.S. Food and Drug Administration (FDA) has licensed Menactra (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) for protection against meningococcal disease in adolescents and adults aged 11-55 years.

17 Jan 2005

Avastin available across Europe within the next few weeks

Roche has announced that the European Commission has approved Avastin (bevacizumab, rhuMAb-VEGF), the new innovative anti-angiogenesis drug, for the treatment of patients with previously untreated metastatic colorectal cancer.

16 Jan 2005

Committees will weigh up COX-2 benefits and risks

The U.S. Food and Drug Administration (FDA) has announced a joint public meeting of the agency's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee to be held February 16, 17 and 18, 2005.

16 Jan 2005

Evaluation of BAY 43-9006 (Sorafenib) for pancreatic cancer

Oncologists from USC/Norris Comprehensive Cancer Center are running tests on a new pancreatic cancer drug that targets the cancer from two directions.

13 Jan 2005

MHRA and FDA to inspect Chiron's Liverpool manufacturing facility

Chiron Corporation announced at a presentation at the 23rd Annual JPMorgan Healthcare Conference that the company anticipates that the UK Medicines and Healthcare products Regulatory Agency (MHRA), accompanied by U.S. Food and Drug Administration (FDA) inspectors as observers, will conduct a series of inspections of Chiron's Liverpool manufacturing facility.

13 Jan 2005

Major partnership with National Institute of Allergy and Infectious Diseases for Narhex Life Sciences

Australian drug specialist Narhex Life Sciences, has announced a partnership with one of the world’s foremost US medical research centres to evaluate its protease inhibitor Nar DG 35 Prodrug for its activity against Hepatitis C and SARS viruses.

12 Jan 2005

Research breakthrough in treatment of TB and MDR-TB

FASgen Inc.'s compound, FAS20013, has emerged from an intense multi-year program of pre-clinical studies that clearly validate its potential as an ideal new drug for the treatment of tuberculosis and MDR-TB, the disease caused by organisms that are resistant to the drugs now commonly used to treat TB. Initial clinical trials in both TB and MDR-TB are scheduled for later this year.

12 Jan 2005

Myriad Genetics initiates phase 3 clinical trial of Flurizan

Myriad Genetics announced today that it has initiated enrollment in a Phase 3 human clinical trial of its lead therapeutic candidate, Flurizan (MPC-7869), in patients with Alzheimer's disease.

12 Jan 2005

Amarin announces positive results from studies using Miraxion to treat unresponsive depression

Amarin Corporation today announced positive data analysis from two exploratory phase IIa clinical studies using Miraxion (formerly referred to as LAX-101c) to treat depression.

12 Jan 2005

Escalating demand for novel and effective therapeutic approaches underlines growing appeal of peptides

With a 30 per cent revenue share, Europe trails the United States as the second largest regional market for therapeutic peptides. The rising need for new therapeutic approaches combined with the potential of peptides as active pharmaceutical ingredients for effective drug formulation is contributing to rapid market development.

12 Jan 2005

Safety established for Vaxin's first flu vaccine in clinical trial

Vaxin Inc., a privately-held biotechnology company, has demonstrated, in a Phase I human clinical study, that the company's recombinant influenza vaccine provides a potential alternative to traditional flu vaccines.

12 Jan 2005