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.
The Honourable Rona Ambrose, Minister of the Environment, gave Canadians the first and central component of Canada’s New Government’s environmental Agenda when she introduced Canada’s Clean Air Act in Parliament. “We listened to Canadians. They told us they were concerned about worsening air quality and increasing emissions of greenhouse gases,” said Minister Ambrose. “After more than a decade of inaction on the environment by the previous government, Canada’s Clean Air Act is the first step in turning things around to protect the health of Canadians.”
Conventional treatment for genital warts, which are caused by the human papilloma virus (HPV), typically focuses on the visible lesions, leaving the possibility that latent infection could persist. That can result in transmission of the virus to sexual partners, and the infection could progress to cervical cancer.
“Asia has shown significant progress in preparing to fight the spread of the virus, but more help is needed to support Indonesia, where a majority of the country’s provinces have reported the presence of the disease”, United Nations official, David Nabarro.
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.
GlaxoSmithKline (NYSE: GSK) and Flamel Technologies (NASDAQ:FLML) announced FDA approval of once-a-day Coreg CR (carvedilol phosphate) extended-release capsules, for the treatment of three cardiovascular conditions: 1. High blood pressure, also known as hypertension. 2. A heart attack that has reduced how well the heart pumps (known medically as post-myocardial infarction left ventricular dysfunction). 3. Mild to severe heart failure.
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.
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.
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.
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.