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Bonviva, to treat osteoporosis, submitted for marketing authorisation in Europe

Roche and GlaxoSmithKline announced today the submission of a Marketing Authorisation Application to the European authorities for a novel, once-monthly oral formulation of their new bisphosphonate, Bonviva (ibandronate), for the treatment of postmenopausal osteoporosis.

20 Sep 2004

European positive for Cymbalta and Xeristar

Eli Lilly and Company and Boehringer Ingelheim have announced that the Committee for Medicinal Products in Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending approval of duloxetine for the treatment of major depressive episodes.

20 Sep 2004

Crucell and AIDS Vaccine Initiative have signed an exclusive license agreement to develop an AIDS vaccine

Dutch biotechnology company Crucell and the International AIDS Vaccine Initiative (IAVI) have signed an exclusive license agreement to develop an AIDS vaccine based on Crucell’s AdVac® technology.

20 Sep 2004

Wyeth supports FDA recommendation to strengthen antidepressant labeling

Statement by Wyeth Pharmaceuticals supporting the U.S. Food and Drug Administration (FDA) Joint Advisory Committee’s recommendation to strengthen the product labels across the antidepressant category regarding use in the pediatric population.

16 Sep 2004

Prozac, Paxil, Wellbutrin, Zoloft, Celexa, Effexor, Luvox and Remeron should have "Black Box" warnings

A panel of experts has voted 15 to 8 in favour of the Federal Food and Drug Administration (FDA) adding black box warnings to certain medications used to treat depression in children and teenagers.

14 Sep 2004

ID Biomedical to supply meningitis C vaccine to the Canadian government

The Canadian government has retained an option to purchase additional product from the Company in the third and final year of the contract. The total value of the contract, including the third year option, could total approximately $30 million to ID Biomedical.

14 Sep 2004

Which provincial pharmacare system works best to protect Canadians against catastrophic drug costs?

Health-care economy researchers at the University of British Columbia have found there is wide variation in coverage for pharmaceuticals in Canada.

14 Sep 2004

Potential new drug for the treatment of sickle cell disease

The results were published in the June 2004 issue of The British Journal of Haematology (BJH). MX-1520 is a prodrug of vanillin, a very popular food additive generally regarded as safe (GRAS) by the FDA.

13 Sep 2004

Yentreve available in Europe for treatment of stress urinary incontinence

Yentreve (duloxetine hydrochloride) is now available in certain European countries, giving women suffering from moderate to severe stress urinary incontinence (SUI) a pharmaceutical treatment option for the first time.

13 Sep 2004

Phase I clinical trial of new drug for severe asthma

Cambridge Antibody Technology today announced that it is starting a Phase I clinical trial of CAT-354, a human anti-IL-13 monoclonal antibody, which is a potential treatment for severe asthma, following recent approval from the Medicines and Healthcare products Regulatory Agency (MHRA).

8 Sep 2004

Cymbalta approved for diabetic peripheral neuropathy pain

The U.S. Food and Drug Administration has approved Eli Lilly's Cymbalta, a balanced and potent serotonin and norepinephrine reuptake inhibitor. Cymbalta is the first and only FDA-approved treatment for pain caused by diabetic peripheral neuropathy.

8 Sep 2004

FDA approval for chewable ADHD tablets

Alliant Pharmaceuticals has announced FDA approval of Methylin Chewable Tablets and Methylin Oral Solution for the treatment of ADHD. The two products are the first, and only, chewable tablet and oral solution for ADHD to gain FDA acceptance.

7 Sep 2004

Topiramate help patients with alcohol dependence

The drug topiramate helps reduce drinking and improves overall quality of life among patients with alcohol dependence, according to an article in the September issue of the Archives of General Psychiatry.

7 Sep 2004

Ezetrol co-administration with statin therapy lowers LDL cholesterol in diabetics

Results from two new clinical trials show that patients with diabetes and metabolic syndrome who are treated with ezetimibe (EZETROL®) co-administered with a statin experience greater reductions in LDL (“bad”) cholesterol, compared to patients taking a statin alone.

7 Sep 2004

Phico Therapeutics secures funding to tackle superbug

Phico Therapeutics Ltd, a Cambridge-based company that has developed a unique anti-bacterial technology to treat the hospital superbug, MRSA, has raised £550,000 with the help of Oxfordshire Investment Opportunity Network, Europe’s leading technology business angel network.

6 Sep 2004

More than 100 million doses of influenza vaccine available this year in the United States

Despite an Aug. 26 announcement that some doses of influenza vaccine to the United States have been delayed, the Centers for Disease Control and Prevention said the effects of the delay will be minimal - and physicians do not need to order more doses.

5 Sep 2004