Drug | Page 237 of 280 | SpiritIndia.com

Diabetes :: Updates on Counterfeit Blood Glucose Test Strips for LifeScan

On October 13, 2006, the U.S. Food and Drug Administration (FDA) alerted the public to counterfeit blood glucose test strips being sold in the United States for use with various models of LifeScan, Inc., One Touch Brand Blood Glucose Monitors. These test strips are used by people with diabetes to measure their blood glucose. Today’s announcement provides two additional lot numbers that are included in the distribution of counterfeit products, along with descriptions of how to identify them.

Allergy :: Altana’s Omnaris, ciclesonide nasal spray for allergies, allergic rhinitis, hay fever

The Food and Drug Administration (FDA) announced the approval of Omnaris (ciclesonide) nasal spray, a new drug for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis, commonly known as hay fever, in adults and children 12 years of age and older.

Breast Implants :: Silicone gel filled breast implants for canadian women – Health Canada

Health Canada announced that it will grant licences with conditions to Inamed Corporation and Mentor Medical Systems to market their silicone gel-filled breast implants in Canada. These Class IV licences are conditional on the manufacturers meeting several requirements to ensure their devices continue to meet the safety and effectiveness requirements of the Medical Devices Regulations.

Health :: Glivec, imatinib approved for five rare life threatening disorders

In another important milestone, Glivec? (imatinib) has received US regulatory approval to help patients with five distinct and potentially life-threatening disorders, representing the first time that a regulatory authority has ever simultaneously approved one targeted medicine for so many disorders. With today’s decision, and in only five years, Glivec has now been approved in the US for seven diseases, including two solid tumors and five blood disorders with molecular targets known to be inhibited by the drug.

Bipolar Depression :: AstraZeneca’s SEROQUEL for Bipolar Depression Treatment

AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved SEROQUEL? (quetiapine fumarate) for the treatment of patients with depressive episodes associated with bipolar disorder. SEROQUEL already is approved for the treatment of acute manic episodes associated with bipolar I disorder and for the treatment of schizophrenia. SEROQUEL is now the first and only single medication approved by the FDA to treat both depressive and manic episodes associated with bipolar disorder.

Health :: NeuGene Antisense to Alter Drug Metabolism in Humans

AVI BioPharma, Inc. (Nasdaq: AVII), presented data and analysis from four NeuGene? antisense clinical studies at the second annual meeting of the Oligonucleotide Therapeutics Society at Rockefeller University in New York. The studies showed that AVI-4557 inhibited the metabolic enzyme cytochrome P450 (CYP), a liver enzyme responsible for the metabolism or breakdown of approximately half of currently marketed drugs.

HIV :: REYATAZ, atazanavir sulfate for Adults With HIV-1 Infection

Bristol-Myers Squibb Company (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has granted approval of a new 300 mg single capsule formulation of REYATAZ? (atazanavir sulfate) for the treatment of HIV-1 infection in adults as part of combination therapy. Taken once daily along with ritonavir and food as part of a anti-HIV drug regimen, the REYATAZ 300 mg single capsule formulation can replace two REYATAZ 150 mg capsules for: patients who have previously received anti-HIV medicines, patients who will be receiving tenofovir disoproxil fumarate, and patients who have never taken anti-HIV medicines that require SUSTIVA? (efavirenz) as part of their anti-HIV drug regimen. The REYATAZ single capsule formulation will be available in the United States within seven business days.

Inflammatory Disease :: Array BioPharma’s MEK Inhibitor, ARRY-438162, meets initial clinical objectives

Array BioPharma Inc. (Nasdaq: ARRY) announced that its first-in-class MEK inhibitor for the treatment of inflammatory diseases, ARRY-438162, has met its primary objectives in a single ascending dose clinical study involving 20 healthy volunteers. These results were presented by Array?s President and Chief Scientific Officer, Kevin Koch, Ph.D., at the 14th International Inflammation Research Association Conference in Cambridge, Maryland.

Lung Cancer :: GALES Trial of ALIMTA, pemetrexed for injection in Small Cell Lung Cancer

Eli Lilly and Company has launched a major clinical trial evaluating ALIMTA (pemetrexed for injection) in extensive-stage small cell lung cancer (SCLC), a devastating and rapidly spreading form of lung cancer. This international trial, expected to be the largest ever to be conducted in SCLC(1), will assess the potential clinical benefit of pemetrexed in combination with carboplatin, a commonly-used chemotherapeutic agent, in direct comparison to the current leading treatment option of etoposide in combination with carboplatin.

Hunter Syndrome :: ELAPRASE, idursulfase – therapy for Hunter syndrome patients in Europe

Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) today reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending approval of ELAPRASE for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II). The EU Marketing Authorisation is expected early in 2007 and will result in unified labelling that will be valid in the current EU 25 member states as well as in Iceland and Norway.