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Thyroid cancer drug given expanded approval by FDA

The U.S. Food and Drug Administration (FDA) has given expanded approval for a drug used to treat thyroid cancer.

19 Dec 2007

New scheme to revolutionise system of prescribing medicines

Patients could be saved millions of trips to their GP under a new scheme that has the potential to revolutionise the system of prescribing medicines.

18 Dec 2007

Oral diabetes medication - new guidelines

A pair of plain-language guides that outline the latest scientific evidence on the effectiveness and safety of oral medications for adults with type 2 diabetes are now available from HHS' Agency for Healthcare Research and Quality.

18 Dec 2007

Eli Lilly and BioMS Medical announce licensing and development agreement

Eli Lilly and Company and BioMS Medical Corp. have announced that the two companies have entered into a licensing and development agreement granting Lilly exclusive worldwide rights to BioMS Medical's lead multiple sclerosis (MS) compound, MBP8298.

18 Dec 2007

NCPA applauds pharmacy tricare provisions in the congressional passage of the defense authorization bill

The National Community Pharmacists Association (NCPA) thanks Congress for including key pharmacy provisions in the Defense Authorization Act Conference Report for fiscal year 2008 it passed last week.

17 Dec 2007

New principle for developing vaccines

Infections with a certain type of bacteria (group B streptococcus) can lead to severe, sometimes life-threatening, infections in newborn infants.

14 Dec 2007

BioMarin Pharmaceutical announces FDA approval for Kuvan

BioMarin Pharmaceutical Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Kuvan(TM) (sapropterin dihydrochloride) Tablets, the first specific drug therapy approved for the treatment of phenylketonuria (PKU).

14 Dec 2007

GlaxoSmithKline response to JAMA article on ICES retrospective analysis

The following is GlaxoSmithKline's response to the retrospective analysis by the Institute for Clinical Evaluative Sciences (ICES) titled "Thiazolidinediones and Cardiovascular Outcomes in Older Patients with Diabetes".

13 Dec 2007

Cell-tracking software speeds drug development

Time is money, especially in the race to discover new anti-inflammatory drugs and bring them to market.

13 Dec 2007

Carbamazepine based drugs to include new advice for patients with Asian ancestry

The U.S. Food and Drug Administration today announced that the manufacturers of drugs containing the active ingredient carbamazepine have agreed to add to the drugs' labeling a recommendation that, before starting therapy with the drugs, patients with Asian ancestry get a genetic blood test that can identify a significantly increased risk of developing a rare, but serious, skin reaction.

13 Dec 2007

Novel technique using computer modeling identifies potential side effects of pharmaceuticals

Early identification of adverse effects of drugs before they are tested in humans is crucial in developing new therapeutics, as unexpected effects account for a third of all drug failures during the development process.

12 Dec 2007

FDA and Pharsight continue to collaborate under CRADA

Pharsight Corporation has provided an update on its Cooperative Research and Development Agreement (CRADA) with the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER).

12 Dec 2007

SEBIA joins EDMA corporate membership

EDMA , the European Diagnostic Manufacturers Association welcomes SEBIA as new corporate affiliate, bringing the Association's overall membership up to 33 major IVD companies and 21 National Associations.

12 Dec 2007

BioMS Medical's phase III U.S. multiple sclerosis trial receives positive safety review

A leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) has reviewed data from the Company's on-going MAESTRO-03 U.S. pivotal phase III clinical trial of MBP8298 for the treatment of secondary progressive MS and recommended that the trial continue.

12 Dec 2007

Popular heartburn drug given the all clear

Concerns that a drug used to treat stomach conditions such as heartburn could cause heart problems have been laid to rest by a comprehensive review.

11 Dec 2007

New drug candidate knocks out resistant form of chronic myeloid leukemia

Oregon Health & Science University Cancer Institute researchers have found a new, experimental drug candidate it to be effective against a highly resistant mutation in chronic myeloid leukemia (CML).

10 Dec 2007

Nanogen reaches milestone in influenza project

Nanogen, Inc. has announced that it has delivered the second phase milestone requirements, including the point-of-care prototype device to detect influenza viruses rapidly in clinical samples, to the Center for Disease Control and Prevention (CDC) for their evaluation.

10 Dec 2007

MDs' reactions to pharma marketing influenced by brand, side effects

A study of pharmaceutical companies' marketing to physicians shows that doctors are most influenced by brand preference and marketing that addresses the problems of drugs with many side effects, according to the Management Insights feature in the current issue of Management Science, the flagship journal of the Institute for Operations Research and the Management Sciences (INFORMS).

10 Dec 2007

ImmunoVaccine Technologies to acquire Immunotope

ImmunoVaccine Technologies Inc. (IVT), a Nova Scotia-based vaccine enhancement company, has signed a binding memorandum of understanding to acquire Immunotope Inc., a Pennsylvania-based biotechnology company developing immunotherapy products for the treatment and prevention of cancer and infectious diseases.

10 Dec 2007

Resverlogix receives FDA approval to start clinical trial for RVX-208

Resverlogix Corp. has announced that it has received approval by the US Food and Drug Administration (FDA) to initiate a Phase 1a clinical trial of oral RVX-208 in the USA. RVX-208 is a novel first-in-class small molecule that increases the production of ApoA-I and HDL.

10 Dec 2007