World Pharma/Clinical Trial Regulatory (From Nov. 29 to Nov. 30)
On Nov. 30, 2012, Exelixis, Inc. (EXEL) announced that the U.S. Food and Drug Administration (FDA) have approved COMETRIQ™ (cabozantinib) for the treatment of progressive, metastatic medullary thyroid cancer (MTC). COMETRIQ is an inhibitor of multiple receptor tyrosine kinases involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and maintenance of the tumor microenvironment. The COMETRIQ label has boxed warnings concerning risk of perforations and fistulas, and hemorrhage.
On Nov. 30, 2012, AstraZeneca has won approval for its new heart drug Brilinta in China, an increasingly important market for the British pharmaceuticals group. China's State Food and Drug Administration has issued an drug import license for the product, meaning it will now be available for treating patients with acute coronary syndrome in the country, the company said on Thursday. Brilinta has proved better than the cheaper generic medicine clopidogrel in preventing the recurrence of heart attacks, but its sales to date in markets around the world have been disappointing.
On Nov. 29, 2012, Theravance, Inc. (NASDAQ: THRX) announced a favorable outcome of the Anti-Infective Drugs Advisory Committee (AIDAC) of the U.S. Food and Drug Administration (FDA) meeting on VIBATIV® (telavancin) for the treatment of nosocomial pneumonia (NP) due to susceptible isolates of Gram-positive microbiology organisms.
On Nov. 29, 2012, Johnson & Johnson's ($JNJ) Janssen has taken a step closer to gaining approval for the first new way of combating tuberculosis in decades. And an FDA advisory committee voted 18-0 in favor of efficacy of the experimental med, bedaquiline, for combating multidrug-resistant cases of the infection. Yet the panel was more mixed on the risks of the drug, voting 11-7 in support of safety data, as some experts question the effects of the treatment on the liver and heart, according to Reuters report.
On Nov. 27, 2012, Gilead Sciences ($GILD) is sprinting ahead with initial positive results from a Phase III study for what could be a first all-oral combination therapy for certain patients with chronic hepatitis C virus in the U.S. The company reported clinical cures for about three quarters of patients with genotypes 2 or 3 of the liver-damaging virus on a combination of its experimental "nuc" sofosbuvir or GS-7977 and standard ribavirin.
Tags: Metastatic Medullary Thyroid Cancer (MTC), Heart Drug, Nosocomial Pneumonia (NP), Tuberculosis, Chronic Hepatitis C