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AMAG receives Health Canada Notice of Non-Compliance for Feraheme NDS

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that it has received a Notice of Non-Compliance (NON) from Health Canada regarding its New Drug Submission (NDS) for Feraheme® (ferumoxytol) injection for intravenous (IV) use for the treatment of iron deficiency anemia in adult chronic kidney disease patients.

9 Feb 2011

FDA grants Actavis marketing approval for Pantoprazole Sodium Delayed-Release Tablets

Actavis Group, an international generic pharmaceuticals company, today announced that it has received approval from the US Food & Drug Administration to market Pantoprazole Sodium Delayed-Release Tablets, USP.

9 Feb 2011

NMS Labs launches unique test for Methotrexate

NMS Labs launches another unique test suitable for the evaluation of toxicity vs. efficacy and helping physicians with therapeutic drug monitoring of patients for the therapeutic agent, Methotrexate.

8 Feb 2011

Positron anticipates expanded market opportunity for Attrius PET scanner

Positron Corporation a molecular imaging solutions company focused on nuclear cardiology, announced today that with the conditional U.S. Food and Drug Administration (FDA) approval of Eli Lilly's PET imaging agent Amyvid (florbetapir), it expects to see an expanded market opportunity for its Attrius® PET scanner.

8 Feb 2011

ASBP concerned over FDA rejection of Contrave drug

The American Society of Bariatric Physicians is concerned that the FDA recently rejected the weight-loss drug Contrave, contradicting the FDA advisory panel's recommendation for approval. The rejection of Contrave marks the third weight-loss drug to be rejected by the FDA in the past six months.

8 Feb 2011

Total flu cover with one shot

In a medical breakthrough, English scientists have developed a so-called “universal” vaccine to influenza - one that protects against all strains of the potentially deadly illness. This would do away with the need for a new vaccine each flu season they say. Seasonal flu affects up to 20 percent of the population and kills an average of 24,600 people each year. This vaccine would act against swine flu as well assure researchers.

8 Feb 2011

Avandia label revised as per FDA directive

Following the 2010 FDA directive, pharmaceutical manufacturer Glaxo-SmithKline announced this Monday that they have modified the label for diabetes drug rosiglitazone (Avandia). The new label restricts its use to patients already taking it or to those who have failed other antiglycemic drugs.

8 Feb 2011

ScinoPharm to be Clinical Data's sole API supplier of vilazodone hydrochloride during Viibryd's launch

ScinoPharm, a leading active pharmaceutical ingredient (API) and contract research and manufacturing (CRAM) service provider to the global pharmaceutical and biotechnology industry, will provide commercial manufacturing service of vilazodone hydrochloride active pharmaceutical ingredient (API) for Clinical Data, Inc.'s Viibryd™, a new drug entity recently approved by the United States Food and Drug Administration.

8 Feb 2011

PDL, UCB enter definitive settlement agreement to resolve all legal patent disputes

UCB SA, on behalf of its affiliate UCB Pharma S.A., and PDL BioPharma, today jointly announced that the companies have entered into a definitive settlement agreement that resolves all legal disputes between them, including those relating to UCB's pegylated humanized antibody fragment, Cimzia, and PDL's patents known as the Queen et al. patents.

8 Feb 2011

Elan 2010 total revenue increases 5% to $1,169.7 million

Elan Corporation, plc today reported its fourth quarter and full-year 2010 financial results and provided financial guidance for 2011.

8 Feb 2011

FDA warning leads to decrease in use of atypical antipsychotics for treatment of dementia

A warning issued by the Food and Drug Administration regarding the use of atypical antipsychotics for the treatment of dementia was associated with a significant decline in the use of these medications for treating dementia symptoms in elderly patients, according to a report in the February issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

8 Feb 2011

TREK1 activity offers a key target for fluoxetine and other antidepressant drugs

Using a unique and relatively simple cell-based fluorescent assay they developed, scientists with the U.S. Department of Energy's Lawrence Berkeley National Laboratory and the University of California, Berkeley have identified a means by which fluoxetine, the active ingredient in Prozac, suppresses the activity of the TREK1 potassium channel.

8 Feb 2011

Anthem Blue Cross reminds seniors in Maine to get vaccinated against annual flu, pneumonia

While the seasonal flu can be very serious for patients of any age, senior citizens are particularly vulnerable. That's why Anthem Blue Cross and Blue Shield in Maine is reminding seniors across the state to get their annual flu and pneumonia vaccinations.

8 Feb 2011

Schizophrenia patients who consume antipsychotics appear to lose small amount of brain tissue

Patients with schizophrenia who take antipsychotic medications appear to lose a small but measurable amount of brain tissue over time, according to a report in the February issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

8 Feb 2011

Particle Sciences announces strategic alliance with HORIBA Instruments

Particle Sciences, Inc., a leading pharmaceutical CRO, is pleased to announce the establishment of a strategic alliance with HORIBA Instruments of Irvine, CA, which is the U.S. sales and marketing division of HORIBA Limited of Kyoto, Japan.

8 Feb 2011

Study on non-surgical approach for treatment of liver hydatidosis

Concerning treatment, until recently the only definitive treatment for hydatid disease had been surgery. Different surgical techniques and procedures have been carried out and even in some cases, a liver transplant has been required. Advances in drug therapy has been influenced by the introduction of albendazole and accelerated by addition of praziquantel, but this requires a long period of treatment i.e. up to a year or more, and is not effective for everyone.

8 Feb 2011

Study reports significant decline in second-generation medication use for dementia

As loved ones with dementia disappear into symptoms of aggression, agitation or delusions, families are left with few good medical solutions. A new generation of antipsychotic medications gained popularly in the 1990s because they avoided side effects such as Parkinson's syndrome associated with conventional antipsychotic medications used to treat dementia.

8 Feb 2011

Study: Cannabis use appears to be linked with earlier onset of psychotic illness

Cannabis use appears to be associated with an earlier onset of psychotic illness, according to a meta-analysis of previously published studies posted online today that will appear in the June print issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

8 Feb 2011

Tufts announces public launch of Institute for Biomedical Partnerships, HUB website

Tufts University today announced the public launch of the Tufts Institute for Biomedical Partnerships website/HUB: www.tuftspharmapartners.org.

8 Feb 2011

Natco Pharma submits ANDA to FDA for generic version of Tamiflu 75 mg capsules

Gilead Sciences, today announced receipt of a Paragraph IV Certification Notice Letter advising that Natco Pharma Limited submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration requesting permission to manufacture and market a generic version of Tamiflu 75 mg capsules.

7 Feb 2011

Pharmaceutical News

AMAG receives Health Canada Notice of Non-Compliance for Feraheme NDS

FDA grants Actavis marketing approval for Pantoprazole Sodium Delayed-Release Tablets

NMS Labs launches unique test for Methotrexate

Positron anticipates expanded market opportunity for Attrius PET scanner

ASBP concerned over FDA rejection of Contrave drug

Total flu cover with one shot

Avandia label revised as per FDA directive

ScinoPharm to be Clinical Data's sole API supplier of vilazodone hydrochloride during Viibryd's launch

PDL, UCB enter definitive settlement agreement to resolve all legal patent disputes

Elan 2010 total revenue increases 5% to $1,169.7 million

FDA warning leads to decrease in use of atypical antipsychotics for treatment of dementia

TREK1 activity offers a key target for fluoxetine and other antidepressant drugs

Anthem Blue Cross reminds seniors in Maine to get vaccinated against annual flu, pneumonia

Schizophrenia patients who consume antipsychotics appear to lose small amount of brain tissue

Particle Sciences announces strategic alliance with HORIBA Instruments

Study on non-surgical approach for treatment of liver hydatidosis

Study reports significant decline in second-generation medication use for dementia

Study: Cannabis use appears to be linked with earlier onset of psychotic illness

Tufts announces public launch of Institute for Biomedical Partnerships, HUB website

Natco Pharma submits ANDA to FDA for generic version of Tamiflu 75 mg capsules

How industrial hygiene flow calibration supports defensible exposure data

How electrical engineering ensures accurate calibration and patient safety

The importance of ketones from a clinical and medical perspective

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