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New and Generic Drug Approvals from FDA

This newly approved or tentatively approved drug listing from the FDA is an interim page intended to provide timely information on new drug products as a more comprehensive page is developed.

12 Apr 2004

FDA approval of stomach acid suppressant

Wyeth Pharmaceuticals, a division of Wyeth, has announced that the U.S. Food and Drug Administration (FDA) approved the reformulation of the stomach acid suppressant, PROTONIX(R) I.V. (pantoprazole sodium) for Injection.

12 Apr 2004

Medicare to launch website showing comparative drug pricing

Medicare has announced it will be publishishing detailed information comparing the prices of most prescription drugs, which is set to shake up the pharmaceutical industry.

12 Apr 2004

FDA issues warning againts street drug alternatives

FDA issued a warning in February 2004, about adverse events experienced by four teenagers after they consumed Green Hornet Liquid that contained high levels of the over-the-counter drugs diphenhydramine and dextromethorphan.

11 Apr 2004

Bush Administration Undermining World Health Organisation Guidelines

Since the release of President George W. Bush's Emergency Plan for AIDS Relief, the U.S. global AIDS coordinator and former CEO of Eli Lilly, Randall Tobias, and other Bush administration officials have made public remarks that question the quality of generic antiretroviral drugs and undermine international quality standards set by the World Health Organization.

11 Apr 2004

Ephedra - herbal stimulant sales illegal as of Monday

Sales of the herbal stimulant ephedra become illegal in the United States on Monday, barring a last-minute reprieve from a federal judge.

11 Apr 2004

Natural medication shown to not always be a safe alternative to synthetic medication

The common perception that if medication is natural then it must be safe has recently come under fire from a researh by a Consumer Reports magazine. The consumer publication found a dozen herbal supplements, some banned in Asia, Europe and Canada but widely available in the United States, may cause cancer, kidney or liver damage and even death.

10 Apr 2004

Indevus announces agreement with Pliva for overactive bladder treatment drug

Indevus Pharmaceuticals, Inc. has announced that it has entered into a co-promotion and licensing agreement with PLIVA d.d. through its specialty branded subsidiary, Odyssey Pharmaceuticals Inc., for the U.S. commercialization of SANCTURA™ (trospium chloride), under review by the U.S. Food and Drug Administration (FDA) as a treatment for overactive bladder.

10 Apr 2004

Generic ribavirin product launched in the United States

Schering-Plough Corporation has announced that its wholly owned subsidiary Warrick Pharmaceuticals has launched a generic ribavirin product in the United States.

9 Apr 2004

A drug that improves function of retinal blood vessels may be able to reduce the risk of stroke

The small study found that endothelial function is abnormal in eye blood vessels of patients who have early-stage hypertension, but that treatment with an angiotensin-receptor blocker (ARB) drug improves endothelial function. The endothelium is the lining of vessel walls and plays a key role in the vessels’ ability to relax and to constrict.

9 Apr 2004

Roche announces new dosing strategy

Roche has announced results from a study demonstrating that the new boosted dosing regimen for its protease inhibitor Invirase(R) (saquinavir 1000 mg with ritonavir 100 mg twice-daily) has no significant interactions when it is co-administered with tenofovir disoproxil fumarate (300 mg once-daily).

9 Apr 2004

Hepatitis C wonder drug Ribasphere gets approval from FDA

The President and CEO of Three Rivers Pharmaceuticals, Donald J. Kerrish, RPh., stated, “The approval of Ribasphere™ marks a milestone in the treatment of HCV. Ribasphere™ is positioned to break down the economic barriers that have existed for the past decade in treating this chronic and potentially deadly disease.” Traditionally the cost of treatment for HCV can range from $20,000 – $25,000 annually. “Our aim is to bring affordable medicine to all individuals infected with this dreadful disease.” Mr. Kerrish continued.

8 Apr 2004

Unique heart arrhythmia drug represents one of the first molecular-based therapies for heart failure

Heart researchers at Columbia University Medical Center have developed and tested a unique heart arrhythmia drug that could prevent the sudden death of millions of people with heart failure as well as people with an inherited heart disorder. The drug represents one of the first molecular-based therapies for heart failure and avoids the toxicity of current treatments.

8 Apr 2004

Cinacalet helps control overactive thyroids, a major complication of advanced kidney disease

A new drug can help control an overactive thyroid, a major complication of advanced kidney disease, by playing a trick on the gland, a new study finds. The drug, cinacalet, is much more effective at keeping the parathyroid gland working normally than a placebo, according to the study. It may be a good alternative to standard therapy, researchers said.

7 Apr 2004

Research shows that intense high dose cholesterol lowering drugs result in a major reduction in deaths and severe heart attacks

If you want to increase your chances of living longer, taking cholesterol drugs is an easy way to do it. That's the message from a Harvard study of 4,162 people hospitalized in 350 places in eight countries. It is the first research to show that intense lowering of cholesterol results in a major reduction in deaths and severe heart attacks.

7 Apr 2004

Oral sildenafil improved exercise tolerance, cardiac output and quality of life in 22 patients with primary pulmonary hypertension

Oral sildenafil (Viagra®) improved exercise tolerance, cardiac output and quality of life in 22 patients with primary pulmonary hypertension, according to the results of the first randomized, placebo-controlled, double-blind, crossover study, reported in the April 7, 2004 issue of the Journal of the American College of Cardiology.

6 Apr 2004

Phase 3 study of drug teduglutide in patients with short bowel syndrome

Teduglutide is an analog of glucagon-like peptide 2 (GLP-2), a naturally occurring hormone that regulates the growth, proliferation and maintenance of cells lining the gastrointestinal tract. Teduglutide has been shown in animal studies and previous human clinical trials to increase the size and number of these cells, thereby increasing the absorptive surface area of the intestines.

6 Apr 2004

Collaboration to create a series of small molecule drugs leads against a Takeda target

Array BioPharma Inc. today announced the commencement of a drug discovery collaboration with Takeda Chemical Industries, Ltd. to create a series of small molecule drug leads against a Takeda target. This collaboration is in addition to Array's existing research agreement with Takeda that began in 2001.

5 Apr 2004

NeoRx Corporation acquires worldwide rights to platinum-based anti-cancer agent

NeoRx Corporation today announced that it has acquired from AnorMED Inc. the worldwide exclusive rights, excluding Japan, to develop, manufacture and commercialize AMD473, a platinum-based anti-cancer agent. AMD473 has been administered to more than 500 cancer patients in phase I and phase II clinical trials, demonstrating anti-cancer activity in a wide range of tumors and a manageable safety profile. NeoRx expects to initiate clinical studies of AMD473 in one or more cancer indications in the second half of this year.

5 Apr 2004

SkyePharma agreement with Medeus Pharma for marketing and distribution of DepoMorphine

SkyePharma PLC has announced that it has entered into a strategic marketing agreement with Medeus Pharma for the marketing and distribution of DepoMorphine(TM) in Europe. DepoMorphine(TM) is SkyePharma's novel sustained-release injectable formulation of morphine for relief of moderate-to-severe post-operative pain. DepoMorphine(TM) was filed in the US and Europe last year and approvals are anticipated to commence in the second half of 2004.

5 Apr 2004

Pharmaceutical News

New and Generic Drug Approvals from FDA

FDA approval of stomach acid suppressant

Medicare to launch website showing comparative drug pricing

FDA issues warning againts street drug alternatives

Bush Administration Undermining World Health Organisation Guidelines

Ephedra - herbal stimulant sales illegal as of Monday

Natural medication shown to not always be a safe alternative to synthetic medication

Indevus announces agreement with Pliva for overactive bladder treatment drug

Generic ribavirin product launched in the United States

A drug that improves function of retinal blood vessels may be able to reduce the risk of stroke

Roche announces new dosing strategy

Hepatitis C wonder drug Ribasphere gets approval from FDA

Unique heart arrhythmia drug represents one of the first molecular-based therapies for heart failure

Cinacalet helps control overactive thyroids, a major complication of advanced kidney disease

Research shows that intense high dose cholesterol lowering drugs result in a major reduction in deaths and severe heart attacks

Oral sildenafil improved exercise tolerance, cardiac output and quality of life in 22 patients with primary pulmonary hypertension

Phase 3 study of drug teduglutide in patients with short bowel syndrome

Collaboration to create a series of small molecule drugs leads against a Takeda target

NeoRx Corporation acquires worldwide rights to platinum-based anti-cancer agent

SkyePharma agreement with Medeus Pharma for marketing and distribution of DepoMorphine

Streamlining Immuno-Oncological Therapeutic Antibody Discovery

Applying a Proteomics-based Approach to the Clinic

Proteomics & DIA Mass Spectroscopy in Neurodegenerative Disease Research

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