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GlaxoSmithKline receives NDA for Coreg CR

GlaxoSmithKline has announced that the new drug application (NDA) for Coreg CR has been accepted for review by the U.S. Food and Drug Administration (FDA).

17 Mar 2006

Drug trial nightmare - two still critically ill

In the drug trial nightmare which has left six men very ill in a London Hospital two remain in intensive care and are not expected to make any early improvement, according to their doctor Ganesh Suntharalingham, Northwick Park Hospital's Clinical Director of Intensive Care.

17 Mar 2006

Lives in danger as drug trial goes horribly wrong

In a drug trial which went horribly wrong two men are critically ill in a London hospital and four others are seriously ill, after suffering violent reactions to a new drug they took as part of a clinical trial.

16 Mar 2006

Drug trial goes wrong and six end up intensive care

After taking part in a clinical trial of a new drug six men are now seriously ill in a north London hospital in the UK.

15 Mar 2006

New agreement on Chinese malaria vaccine candidate

In a move that promises to expand the clinical testing of another promising malaria vaccine candidate, the US-based PATH Malaria Vaccine Initiative (MVI) and the Chinese company Shanghai Wanxing Bio-Pharmaceuticals today announced an agreement that supports the development of a pediatric malaria vaccine against Plasmodium (P.) falciparum, the most deadly strain of malaria.

15 Mar 2006

Best seller Lipitor shown to improve kidney function

According to drug maker Pfizer it's top selling product worldwide, the cholesterol lowering medication Lipitor (Atorvastatin) has been shown to improve kidney function in patients with heart disease.

13 Mar 2006

Nabi Biopharmaceuticals receives Fast Track status for nicotine vaccine

Nabi Biopharmaceuticals today announced that NicVAX (Nicotine Conjugate Vaccine), the company's novel investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA).

9 Mar 2006

Drug shortfall as more than 5,000 conditions need medication

Only seven per cent of drug applications for treating people with rare diseases were approved in Europe between 2000 and 2004, despite the fact that there are currently more than 5,000 conditions needing medication.

9 Mar 2006

Revatio now available in the UK

Patients in the UK suffering from a rare life-threatening heart condition, pulmonary arterial hypertension (PAH), could soon be offered a new treatment.

8 Mar 2006

MS sufferers lobby for return of Tysabri

Despite the deaths of two people among the thousands treated with a promising multiple sclerosis drug, MS patients are trying to persuade the U.S. government to allow the drug back onto the market.

8 Mar 2006

Novavax and Bharat Biotech form alliance for influenza vaccine development

Novavax and Bharat Biotech International Limited (BBIL), have jointly announced a strategic alliance to pursue the rapid development of pandemic influenza vaccine for India and certain other south Asian markets.

7 Mar 2006

Tibotec Pharmaceuticals receives NDA for investigational HIV protease inhibitor

Tibotec Pharmaceuticals has announced that the New Drug Application (NDA) for TMC114, an investigational HIV protease inhibitor, has been accepted for priority review by the United States Food and Drug Administration (FDA).

7 Mar 2006

Will the FDA rise to the occasion and admit their natalizumab mistake?

When Anita Louise Smith enrolled in an experimental drug trial in 2002 in Colorado, she had a diagnosis of multiple sclerosis but no symptoms and was looking to reduce the chances of being ravaged by the disease.

7 Mar 2006

Pharmaceutical brochures don't always present accurate data

A study published in the journal BMC Family Practice found that three out of twenty promotional brochures studied contained data that was different from the original study on the effects of the drug.

7 Mar 2006

Artificial intelligence addresses the problem of confusing drug names

Was that Xanex or Xanax? Or maybe Zantac? If you're a health care professional you'd better know the difference--mistakes can be fatal.

7 Mar 2006

5,000 rare diseases need drugs, but Europe only approves a handful each year

6 Mar 2006

Next-generation drug development: risky and costly, but worth it

Generic drugs, which drive a $40 billion dollar generics industry expected to hit $60 billion by 2007, account for 53% of all prescriptions filled in the United States today.

6 Mar 2006

Topical therapies show promise for Psoriasis

Psoriasis, a chronic skin condition characterized by thick, red, scaly patches that itch and bleed, not only makes the activities of daily life difficult, but also can affect a person's emotional well being.

6 Mar 2006

UCB submits application to FDA for new treatment in Crohn's disease

UCB has announced the submission of a Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) for the approval of CIMZIA (certolizumab pegol, CDP870) for the treatment of patients with Crohn's disease.

6 Mar 2006

FDA grants priority review for Revlimid

Celgene Corporation announced that the U.S. Food and Drug Administration (FDA) has granted a Priority Review designation to its Supplemental New Drug Application (sNDA) for REVLIMID (lenalidomide) for the treatment of relapsed or refractory multiple myeloma.

6 Mar 2006