Pharmaceutical News

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A vitamin B pill that drastically lowers blood levels of homocysteine could one day be used to prevent dementia

High blood levels of homocysteine are a risk factor for stroke and dementia, including Alzheimer’s disease. Raised levels damage nerves and blood vessels, and lead to a loss of brain tissue in patients.

4 Dec 2004

FDA approval of cream to treat bacterial vaginosis

KV Pharmaceutical Company has announced that it has received approval from the United States Food and Drug Administration (FDA) to market Clindesse (clindamycin phosphate) Vaginal Cream, 2%, a single-dose prescription cream therapy indicated to treat bacterial vaginosis ("BV").

3 Dec 2004

World Health Organization is reinstating two antiretrovirals manufactured by Cipla Ltd

The two medicines (which are used in the treatment of AIDS) had been delisted by WHO in May this year due to non-compliance with international standards at the contract research organizations (CROs) hired by Cipla to conduct bioequivalence tests on the products.

30 Nov 2004

Novel anti-obesity compound shows promise for treatment of obesity

Arena Pharmaceuticals announced today results from the dosing phase of its Phase 1b clinical trial of APD356, an orally administered small molecule designed to regulate satiety (and perhaps metabolism) for the treatment of obesity.

30 Nov 2004

Rimonabant could be safer for treating obesity than previous weight-loss drugs

ECRI, a nonprofit health services research agency, recently published a Health Technology Forecast profile on a novel pharmaceutical agent that is in development for the treatment of obesity.

30 Nov 2004

Potential vaccine for the deadly toxin ricin

A potential vaccine for the deadly toxin ricin, a "Category B" biological agent, will enter the first phase of clinical testing in coming weeks at UT Southwestern Medical Center at Dallas.

30 Nov 2004

Biopharmaceuticals industry, a rapidly growing sector within the pharmaceuticals industry

Global manufacturing of biopharmaceuticals has increased significantly over the last decade due to a number of reasons. Biopharmaceuticals offer several advantages such as highly effective and potent action, fewer side effects and the potential to actually cure diseases rather than merely treat the symptoms.

30 Nov 2004

Avastin plus Folfox4 chemotherapy significantly extends survival in second-line metastatic colorectal cancer

Genentech and Roche today announced that a randomized Phase III study of Avastin™ (bevacizumab) plus the FOLFOX4 chemotherapy regimen (oxaliplatin/5-FU/leucovorin), compared to FOLFOX4 alone, in second-line metastatic colorectal cancer patients achieved its primary endpoint of improving overall survival.

29 Nov 2004

Manufacturers in the European active pharmaceutical ingredients market are struggling to overcome a variety of challenges

Manufacturers in the crowded and highly fragmented European active pharmaceutical ingredients (API) market are struggling to overcome a variety of challenges. One of the most pressing of these is the problem of overcapacity.

29 Nov 2004

FDA approves Combunox tablets for the short-term treatment of acute, moderate to severe pain

Forest Laboratories have announced that Combunox (Oxycodone HCl and Ibuprofen) Tablets (CII), the first and only fixed-dose combination of the opioid oxycodone HCl (5 mg) and the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen (400 mg), was approved by the U.S. Food and Drug Administration (FDA) for the short-term management of acute, moderate to severe pain.

29 Nov 2004

FDA approves Remodulin for the treatment of pulmonary arterial hypertension

United Therapeutics Corporation announced today that the U.S. Food and Drug Administration (FDA) has issued an approval letter for the intravenous use of Remodulin based on data establishing its bioequivalence with the previously approved subcutaneous administration of Remodulin.

24 Nov 2004

Scientists join forces to improve the effectiveness of a drug used to treat chronic myeloid leukaemia

Scientists from Glasgow and Liverpool are joining forces to improve the effectiveness of a drug used to treat a form of leukaemia, chronic myeloid leukaemia (CML), which affects 750 people in the UK each year.

24 Nov 2004

MedImmune and Medarex have announced a collaboration to develop antibodies

MedImmune and Medarex have announced a collaboration to develop antibodies targeting interferon-alpha and the type I interferon receptor 1.

24 Nov 2004

FDA approval of Tysabri, for the treatment of multiple sclerosis

Biogen and Elan Corporation have announced that the U.S. Food and Drug Administration (FDA) has approved Tysabri (natalizumab), as treatment for relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical relapses.

24 Nov 2004

Topical cream alternative to Vioxx

A clinical study recently published in The Journal of Rheumatology concludes that a topical cream consisting of a blend of natural oils called cetylated fatty acids significantly increased range of motion and physical performance in patients with osteoarthritis of the knee with no reported side effects.

24 Nov 2004

FDA incapable of protecting America against another Vioxx

The Food and Drug Administration (FDA) tried to discredit one of its own experts after he told a US Senate hearing that the FDA had failed to protect the public over rofecoxib (Vioxx), according to two articles published online by the British Medical Journal.

24 Nov 2004

FDA approves Vesicare (solifenacin succinate) for the treatment of overactive bladder

Vesicare (solifenacin succinate) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of overactive bladder (OAB) with symptoms of urgency, frequency, and urge incontinence.

23 Nov 2004

Information about serious adverse effects of cerivastatin were known within months after drug launched

A review of the published literature and of internal company documents from the manufacturer of cerivastatin, a cholesterol lowering drug removed from the market in 2001, suggests that information about serious adverse effects of this medication was known to the company within months after this drug was launched

23 Nov 2004

Hetero Drugs withdraws antiretrovirals

Following an inspection by the World Health Organization (WHO), generic manufacturer Hetero Drugs Limited, in Hyderbad, India, is withdrawing six antiretrovirals from the WHO prequalification list in order to review data on their bioequivalence.

20 Nov 2004

AstraZeneca reconfirms the safety of Crestor

In the case of Crestor (rosuvastatin calcium), the application for approval was the most extensive ever for a statin involving more than 12,000 patients, and was unanimously recommended for approval by the FDA's advisory board in July of 2003.

20 Nov 2004

Pharmaceutical News

A vitamin B pill that drastically lowers blood levels of homocysteine could one day be used to prevent dementia

FDA approval of cream to treat bacterial vaginosis

World Health Organization is reinstating two antiretrovirals manufactured by Cipla Ltd

Novel anti-obesity compound shows promise for treatment of obesity

Rimonabant could be safer for treating obesity than previous weight-loss drugs

Potential vaccine for the deadly toxin ricin

Biopharmaceuticals industry, a rapidly growing sector within the pharmaceuticals industry

Avastin plus Folfox4 chemotherapy significantly extends survival in second-line metastatic colorectal cancer

Manufacturers in the European active pharmaceutical ingredients market are struggling to overcome a variety of challenges

FDA approves Combunox tablets for the short-term treatment of acute, moderate to severe pain

FDA approves Remodulin for the treatment of pulmonary arterial hypertension

Scientists join forces to improve the effectiveness of a drug used to treat chronic myeloid leukaemia

MedImmune and Medarex have announced a collaboration to develop antibodies

FDA approval of Tysabri, for the treatment of multiple sclerosis

Topical cream alternative to Vioxx

FDA incapable of protecting America against another Vioxx

FDA approves Vesicare (solifenacin succinate) for the treatment of overactive bladder

Information about serious adverse effects of cerivastatin were known within months after drug launched

Hetero Drugs withdraws antiretrovirals

AstraZeneca reconfirms the safety of Crestor

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