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Guidance for generic drugs

The U.S. Food and Drug Administration (FDA) has announced that a Guidance for Industry entitled "Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003

4 Nov 2004

Wyeth shows new Phase III data about its investigational antibiotic, tigecycline

Wyeth Pharmaceuticals recently presented exciting new Phase III data about its investigational antibiotic, tigecycline, based on a clinical trial in patients with complicated intra-abdominal infections (cIAI).

4 Nov 2004

Analysis shows Remicade reduces pain associated with Crohn's disease

According to a new sub-analysis from the ACCENT I (A Crohn's disease Clinical trial Evaluating infliximab in a New long-term Treatment regimen) trial patients who received a three-dose induction regimen of Remicade experienced a significantly greater reduction in pain as assessed by four different pain questions after ten weeks, compared with patients who received a single dose of Remicade.

2 Nov 2004

Maxim Pharmaceuticals to withdraw NDA for advanced malignant melanoma

Maxim Pharmaceuticals has announced that based upon the negative outcome of it's confirmatory Phase 3 clinical trial (M0104) studying Ceplene(TM) (histamine dihydrochloride) in combination with Interleukin-2 (IL-2) in advanced malignant melanoma patients with liver metastases, it plans to close the treatment protocol approved by the FDA earlier this year.

2 Nov 2004

New vaccines to counter biological agents such as anthrax

Scientists at Imperial College London and Hammersmith Hospital are to help develop new vaccines in case of a terrorist release of biological agents such as anthrax.

1 Nov 2004

Studies show Pfizer's Azithromycin Microspheres effective as treatment for respiratory tract infections

Pfizer Inc.'s new investigational microsphere formulation of azithromycin, which is dosed as a one-time-only oral antibiotic, is comparable to other frequently prescribed treatments for some of the most common respiratory tract infections in adult patients.

1 Nov 2004

Tentative approval of testosterone gel product

Par Pharmaceutical Companies today announced that its partner, Paddock Laboratories, has been granted tentative approval by the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for testosterone gel 1%.

1 Nov 2004

No evidence that Glatiramer acetate slows multiple sclerosis progression

In this week's issue of the Lancet Neurology, glatiramer acetate, known as Copaxone(R), was subjected to an independent review. The systematic review, called a Cochrane Review, performed by Dr. Luca Munari and colleagues, challenges the claims of benefit from previous industry- based publications.

1 Nov 2004

Tamiflu significantly reduced the risk of pneumonia in patients diagnosed with flu

Treatment with the antiviral medication Tamiflu (oseltamivir phosphate) significantly reduced the risk of pneumonia in patients diagnosed with flu, according to a new retrospective cohort study of over 70,000 Americans.

1 Nov 2004

Discovery of a number of potent and selective small molecule inhibitors of the hepatitis C (HCV) NS3/4 protease

InterMune announced today the presentation of preclinical data on the discovery and characterization of a number of potent and selective small molecule inhibitors of the hepatitis C (HCV) NS3/4 protease.

1 Nov 2004

Warning on Alzheimer drug mix up

Janssen Pharmaceutica, manufacturer of the Alzheimer drug galantamine (Reminyl), says it has learned of 10 cases in which individuals who should have gotten Reminyl accidentally received the diabetes drug glimepiride (Amaryl).

1 Nov 2004

FDA approves Nastech vitamin B-12 deficiency nasal spray

Nastech Pharmaceutical Company has announced receipt of an approvable letter from the U.S. Food and Drug Administration (FDA) on Nascobal (Cyanocobalamin, USP) Nasal Spray for the treatment of vitamin B-12 deficiency.

1 Nov 2004

Alimta approved as first treatment for Mesothelioma, a deadly cancer caused by asbestos

Lilly UK announced today that Alimta( (pemetrexed) will be available shortly for the treatment of people diagnosed with mesothelioma, a cancer of the lining of the lungs for which there is no known cure. Pemetrexed is the first licenced treatment for malignant pleural mesothelioma, in combination with cisplatin.

1 Nov 2004

U.S. Department of Health & Human Services has announced progress toward expanding the nation's supply of vaccines for flu season

The Food and Drug Administration (FDA) has identified about 5 million doses of influenza vaccine from foreign manufacturers; HHS has been able to recoup an additional 300,000 doses of the injectable vaccine originally bought for federal employees and the military; and a major pneumonia vaccine manufacturer plans to triple its production.

29 Oct 2004

New data supporting the use of Renagel in patients who are new to hemodialysis

Genzyme Corporation announced that investigators tomorrow will unveil new preliminary data supporting the use of Renagel (sevelamer hydrochloride) in patients who are new to hemodialysis.

29 Oct 2004

Micro-array technology is revolutionising current drug development

Gene expression micro-array technology is benefiting all phases of the discovery, development and subsequent use of new cancer therapeutics

29 Oct 2004

Human Genome Sciences announces agreement with GSK for development of drug to treat diabetes

Human Genome Sciences today announced an agreement with GlaxoSmithKline under which GlaxoSmithKline has acquired exclusive worldwide rights to develop and commercialize Albugon (albumin-glucagon-like peptide-1, GLP-1), a drug currently in late-stage preclinical development by Human Genome Sciences for potential use in the treatment of diabetes.

26 Oct 2004

Call for a Senate Inquiry into the pharmacy industry in Australia

With the current Pharmacy Agreement expiring on 30 June 2005 and the current Senate configuration in place until the same date, Dr Glasson said the timing is perfect for a comprehensive review of the protected environment in which the pharmacies operate.

26 Oct 2004

Nonprescription medications to treat upper respiratory infections could save $4.75 billion a year

Using nonprescription, or over-the-counter (OTC), medications to treat common upper respiratory infections could save $4.75 billion a year, according to a new study conducted by researchers from Northwestern University.

26 Oct 2004

New Drug Application for Velac accepted for filing by the FDA

Connetics Corporation, a specialty pharmaceutical company focused on dermatology, today announced that the U.S. Food and Drug Administration has accepted for filing the Company's New Drug Application for Velac

25 Oct 2004

Pharmaceutical News

Guidance for generic drugs

Wyeth shows new Phase III data about its investigational antibiotic, tigecycline

Analysis shows Remicade reduces pain associated with Crohn's disease

Maxim Pharmaceuticals to withdraw NDA for advanced malignant melanoma

New vaccines to counter biological agents such as anthrax

Studies show Pfizer's Azithromycin Microspheres effective as treatment for respiratory tract infections

Tentative approval of testosterone gel product

No evidence that Glatiramer acetate slows multiple sclerosis progression

Tamiflu significantly reduced the risk of pneumonia in patients diagnosed with flu

Discovery of a number of potent and selective small molecule inhibitors of the hepatitis C (HCV) NS3/4 protease

Warning on Alzheimer drug mix up

FDA approves Nastech vitamin B-12 deficiency nasal spray

Alimta approved as first treatment for Mesothelioma, a deadly cancer caused by asbestos

U.S. Department of Health & Human Services has announced progress toward expanding the nation's supply of vaccines for flu season

New data supporting the use of Renagel in patients who are new to hemodialysis

Micro-array technology is revolutionising current drug development

Human Genome Sciences announces agreement with GSK for development of drug to treat diabetes

Call for a Senate Inquiry into the pharmacy industry in Australia

Nonprescription medications to treat upper respiratory infections could save $4.75 billion a year

New Drug Application for Velac accepted for filing by the FDA

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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