Novartis announced the US regulatory approval of Tyzeka(TM) (telbivudine) as a new once-a-day oral treatment for patients with chronic hepatitis B, a disease estimated to affect about 1.25 million people in the US but more than 350 million globally and considered the tenth leading cause of death.
Abbott announced results from a study showing HUMIRA? (adalimumab) induced significantly higher rates of clinical remission compared to placebo in patients with moderately to severely active Crohn’s disease who lost response to, or were intolerant to, infliximab therapy. The data is being presented simultaneously at the American College of Gastroenterology (ACG) annual meeting in Las Vegas and the United European Gastroenterology Week (UEGW) in Berlin.
Speaking at a Ferring-sponsored symposium on the occasion of the 14th United European Gastroenterology Week (UEGW) congress, Christoph Gasche, Associate Professor of Medicine, Medical University of Vienna, Austria presented the findings of an in-vitro study which for the first time demonstrates a mode of action by which mesalazine may reduce the risk of colorectal cancer in Inflammatory Bowel Disease (IBD) patients.
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.
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.
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.
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.
Young people who get a new meningitis shot may be at a slightly higher risk of developing a paralyzing side effect, federal researchers said. Even so, U.S. health officials said the benefits far outweigh the risk of getting the rare condition, Guillain Barre syndrome. They are not backing off their recommendation that most students be vaccinated.