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Innovative new cancer drug enters the first phase of clinical trials

An innovative drug with a new mechanism of action that may be effective against a range of cancers will enter the first phase of clinical trials, it was announced today (Monday) at Cancer Research UK's Senior Researchers Meeting.

24 May 2004

KETEK® (telithromycin) is highly active in vitro against Streptococcus pneumoniae (S. pneumoniae) isolates

Results from an ongoing surveillance study, PROTEKT US (Prospective Resistant Organism Tracking and Epidemiology of the Ketolide Telithromycin – United States) Year 2 (2001-2002), suggest that KETEK® (telithromycin) is highly active in vitro against Streptococcus pneumoniae (S. pneumoniae) isolates, including those resistant to other antimicrobial agents.

24 May 2004

Significant symptom relief reported in clinical trial patients with irritable bowel syndrome

Solvay Pharmaceuticals unveiled this week results from a six-month study of both male and female patients and from a subgroup analysis of males with Irritable Bowel Syndrome with Diarrhea predominance (IBS-D).

24 May 2004

Once-daily treatment with Alvesco (ciclesonide) in asthma patients has no effect on normal adrenal function

New data presented at the American Thoracic Society’s 2004 International Conference show that once-daily treatment with the investigational therapy Alvesco (ciclesonide) in mild-to-moderate asthma patients has no effect on normal adrenal function, as demonstrated by measurements of the hypothalamic-pituitary-adrenal (HPA)-axis.

24 May 2004

An antibiotic, Tigecycline produces 74 percent cure rate in cSSSI patients

An antibiotic, currently being tested in clinical trials, produced a 74 percent cure rate for hospitalized patients with possibly life-threatening, complicated skin and skin structure infections (cSSSI).

23 May 2004

Diabetes drug improves metabolic changes associated with HIV combination therapy

Use of an oral antidiabetes medication produced significant improvement in a group of patients with HIV lipodsytrophy, a syndrome involving the redistribution of fat and other metabolic changes in those receiving combination drug therapy for HIV infection.

20 May 2004

$First drug approved for hormone refractory prostate cancer that has shown a survival benefit$

First drug approved for hormone refractory prostate cancer that has shown a survival benefit

The the Food and Drug Administration (FDA) approved Taxotere (docetaxel), injection in combination with prednisone ( a steroid), for the treatment of patients with advanced metastatic prostate cancer. This is the first drug approved for hormone refractory prostate cancer that has shown a survival benefit.

19 May 2004

FDA approves new drug for bone marrow disease

The Food and Drug Administration (FDA) today announced the approval of Vidaza (azacitidine) injection, the first effective treatment for patients with Myelodysplastic Syndrome (MDS). The product was given Fast Track Status and a priority review.

19 May 2004

Drug combo effective for advanced breast cancer

A pair of studies at UCLA's Jonsson Cancer Center that takes laboratory science to the patients' bedside found that combining the molecularly targeted therapy Herceptin with a specific chemotherapy combination resulted in significant tumor response rates and longer relapse-free periods in women with an aggressive form of advanced breast cancer.

19 May 2004

Variability in weight and drug content of split tablet may put patients at risk of receiving wrong dosage

Back and neck pain sufferers who divide the most frequently prescribed muscle relaxant may be getting anywhere from half to one-and-a-half times the amount of medicine they believe they are taking, suggests a new study examining the practice of tablet splitting.

19 May 2004

A new synthetic chemical may provide framework for future drugs to treat brain-based ailments

A new synthetic chemical may provide the framework for future drugs that can treat a variety of brain-based ailments, ranging from overeating and drug dependency to neuropathic pain.

19 May 2004

Prescription drugs imported by patients into the United States may be unsafe

Prescription drugs imported by patients into the United States may be unsafe, ineffective, adulterated, misbranded, expired or counterfeit, and could result in harm or death, according to AMA Trustee Rebecca J. Patchin, MD, who testified before the Department of Health and Human Services (HHS) Task Force on Drug Importation on May 14.

19 May 2004

Drug-Drug Interaction Initiative to provide pharmacists with reliable drug interaction messaging

Whenever you pick up a prescription at your community pharmacy, the information is entered into a computer database, which immediately checks the new prescription against your current medications and alerts pharmacists about possible interactions between drugs.

18 May 2004

First filing for zoledronic acid in metabolic bone disease

One 15-minute infusion of the intravenous bisphosphonate zolendronic acid more rapidly reduced the biochemical markers of bone turnover in patients with Paget's disease than was seen in a head-to-head comparison with the oral treatment risedronate (95% vs. 75% response rate).

17 May 2004

FDA today alerted consumers not to purchase or use a recalled lot of DU brand nasal decongestant spray

FDA today alerted consumers not to purchase or use a recalled lot of DU brand nasal decongestant spray (distributed by Drugs Unlimited, of Puerto Rico) because it may be contaminated with Burkholderia cepacia – a bacterium that could cause serious, potentially life-threatening infections in some patients. Individuals with compromised immune systems, especially those with cystic fibrosis, could be at risk.

17 May 2004

Statins should not be considered as a stand-alone wonder-drug in the fight against heart disease

Dr John Reid, the Health Secretary for the United Kingdom (UK), announced the reclassification of statins as ‘over the counter’ products in the UK, to be available to members of the public directly from pharmacists without the need for a prescription.

17 May 2004

IMPAX receives final FDA approval for generic version of Sinemet CR

IMPAX Laboratories, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application (ANDA) for Carbidopa/Levodopa Extended Release Tablets, its generic version of Sinemet(R) CR tablets.

17 May 2004

Pharmaceutical agreement involving novel obesity compound

Bristol-Myers Squibb Company and Solvay Pharmaceuticals today announced that the companies have entered into a worldwide agreement for the Solvay compound SLV319, which is currently in Phase I development with potential for use in treating obesity and other metabolic disorders.

17 May 2004

GlaxoSmithKline and Boehringer Ingelheim agree to assess the development of important HIV medicines for the developing world

GlaxoSmithKline plc and Boehringer Ingelheim announced today that both companies welcome the United States' continued involvement in the global response to HIV/AIDS.

17 May 2004

Guidelines for FUZEON (enfuvirtide) are published today in AIDS

New international consensus guidelines for FUZEON (enfuvirtide) are published today in AIDS, the official journal of the International AIDS Society.

17 May 2004

Pharmaceutical News

Innovative new cancer drug enters the first phase of clinical trials

KETEK® (telithromycin) is highly active in vitro against Streptococcus pneumoniae (S. pneumoniae) isolates

Significant symptom relief reported in clinical trial patients with irritable bowel syndrome

Once-daily treatment with Alvesco (ciclesonide) in asthma patients has no effect on normal adrenal function

An antibiotic, Tigecycline produces 74 percent cure rate in cSSSI patients

Diabetes drug improves metabolic changes associated with HIV combination therapy

First drug approved for hormone refractory prostate cancer that has shown a survival benefit

FDA approves new drug for bone marrow disease

Drug combo effective for advanced breast cancer

Variability in weight and drug content of split tablet may put patients at risk of receiving wrong dosage

A new synthetic chemical may provide framework for future drugs to treat brain-based ailments

Prescription drugs imported by patients into the United States may be unsafe

Drug-Drug Interaction Initiative to provide pharmacists with reliable drug interaction messaging

First filing for zoledronic acid in metabolic bone disease

FDA today alerted consumers not to purchase or use a recalled lot of DU brand nasal decongestant spray

Statins should not be considered as a stand-alone wonder-drug in the fight against heart disease

IMPAX receives final FDA approval for generic version of Sinemet CR

Pharmaceutical agreement involving novel obesity compound

GlaxoSmithKline and Boehringer Ingelheim agree to assess the development of important HIV medicines for the developing world

Guidelines for FUZEON (enfuvirtide) are published today in AIDS

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