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Eurand files NDA for Zentase for the treatment of exocrine pancreatic insufficiency

Eurand has announced that Eurand Pharmaceuticals Ltd. initiated the rolling submission of its new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for Zentase for the treatment of Exocrine Pancreatic Insufficiency (EPI). Zentase (formerly EUR-1008), the company's lead product candidate, has been granted fast-track designation by the FDA.

14 Jun 2007

Alli weight loss drug on the U.S. market soon

Alli which is produced by GlaxoSmithKline will be available to consumers in America next week following a 150 million dollar advertising campaign to promote the non-prescription drug.

12 Jun 2007

FDA decision over new obesity drug hangs in the balance

The Food and Drug Administration (FDA) in the United States appears to be holding back on it's decision to grant approval for a weight loss drug.

11 Jun 2007

Buyers beware of cosmeceuticals!

Consumers are spending big bucks on a new category of anti-wrinkle creams and lotions - cosmeceuticals.

8 Jun 2007

Drug giant accused of using stand-over tactics about Avandia

The controversy surrounding GlaxoSmithKline's (GSK) diabetes drug Avandia has been exacerbated by claims from a medical expert that he was threatened with a $4bn lawsuit to try to silence his criticisms of the company's controversial diabetes drug.

7 Jun 2007

CRT and Manchester University announce biomarker alliance with AstraZeneca

Cancer Research Technology Limited (CRT), the cancer-focused development and commercialisation company, and The University of Manchester today announce the establishment of an alliance with AstraZeneca to develop serological pharmacodynamic (PD) biomarkers.

4 Jun 2007

Brits get serious about smokers

Authorities in the UK have given approval for an anti-smoking pill to be available on the National Health Service (NHS).

3 Jun 2007

FDA provides guidance to help increase supply of influenza vaccines

The U.S. Food and Drug Administration (FDA) has issued final recommendations to increase the supply of safe and effective influenza vaccines for both seasonal and pandemic use.

3 Jun 2007

FDA approves Norditropin for short stature in children with Noonan syndrome

Novo Nordisk has announced that Norditropin (somatropin[rDNA origin] injection) received U.S. Food and Drug Administration (FDA) approval for the treatment of short stature in children with Noonan syndrome.

3 Jun 2007

FDA approves Torisel (temsirolimus) for advanced kidney cancer

The U.S. Food and Drug Administration (FDA) hasapproved Torisel (temsirolimus) for the treatment of a certain type of advanced kidney cancer known as renal cell carcinoma.

1 Jun 2007

Mylan receives FDA approval for Azithromycin tablets

Mylan Laboratories Inc. ( NYSE:MYL ) today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Azithromycin Tablets, 250 mg and 500 mg.

1 Jun 2007

Pharmacists play critical role in reducing medication discrepancies

Involving pharmacists in obtaining and assessing a patient's medication history before elective surgery can significantly reduce medication discrepancies upon hospital admission.

30 May 2007

Office of Fair Trading's value-based pricing scheme is well-founded, but could increase overall NHS drug spend

A report by the Office of Fair Trading has recommended that pricing of drugs is based not on how much the drug costs to develop, but on the benefit that the drug can bring.

30 May 2007

Natalizumab returns to market

Just months after receiving FDA approval, natalizumab, a medication for the treatment of multiple sclerosis (MS) and other inflammatory disorders, was voluntarily withdrawn by its manufacturers after three patients developed a brain infection known as Progressive Multifocal Leukoencephalopathy (PML).

28 May 2007

More considered approach to the safety of rosiglitazone needed

A calmer and more considered approach to the safety of rosiglitazone (Avandia) - the GlaxoSmithKline treatment for type 2 diabetes - is needed to avoid unnecessary panic among patients, says an Editorial published online and in an upcoming edition of The Lancet.

28 May 2007

FDA completes review of FluMist

MedImmune, Inc. has announced that the U.S. Food and Drug Administration (FDA) has stated the agency has completed its review of all submissions made related to the supplemental biologics license application (sBLA) to extend the age indication of FluMist (Influenza Virus Vaccine Live, Intranasal).

28 May 2007

FDA takes action against unapproved prescription versions of Mucinex

Adams Respiratory Therapeutics, Inc. reports that the Food and Drug Administration (FDA) has announced that companies must stop manufacturing and distributing unapproved timed-release dosage forms containing guaifenesin.

28 May 2007

FDA approves treatment for bacterial vaginosis

Mission Pharmacal has announced that the U.S. Food and Drug Administration (FDA) approved Tindamax (tinidazole) for the treatment of bacterial vaginosis (BV), the most common vaginal infection among women of childbearing age in the United States.

28 May 2007

Contact lens solution found to cause serious infection

The Food and Drug Administration (FDA) in the United States has issued a warning to health care professionals and consumers regarding a certain contact lens solution.

27 May 2007

Guidelines on skin reactions to Epidermal Growth Factor Receptor Inhibitors (EGFRIs)

Skin reactions to a powerful new class of anti-cancer drugs are frequent, but manageable through a simple and rational treatment approach , usually without the need to reduce the dose or interrupt treatment with potentially life-prolonging chemotherapy, according to an article in the May issue of "The Oncologist."

24 May 2007