Shares of Vivus Inc. surged 77.5 percent Thursday following an overwhelmingly positive vote by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee for its weight loss candidate Qnexa (phentermine/topiramate). (See BioWorld Today, Feb. 23, 2012.) Read More
Analysts responded to EMDAC's surprisingly positive vote in favor of Qnexa. Here is a sampling of their comments on the vote and its impact to the obesity space. Read More
Forest Laboratories Inc. got hesitant, but positive, support Thursday for approval of its inhaled aclidinium bromide as a twice-daily treatment for bronchospasms associated with chronic obstructive pulmonary disease (COPD). Read More
By focusing on protein translation, scientists have gained surprising insights into the control of prostate cancer metastasis, linking it to dysregulation of the protein kinase mTOR. Read More
The Cardiovascular and Renal Drugs Advisory Committee (CRDAC), voted Thursday 7-4, with one abstention and much uncertainty, in favor of the FDA approving Northera from Chelsea Therapeutics International Inc. for treating neurogenic orthostatic hypertension (NOH) in patents with primary autonomic failure due to conditions such as Parkinson's disease, multiple system atrophy and pure autonomic failure, dopamine beta hydroxylase deficiency and nondiabetic autonomic neuropathy. Read More
Privately held Satori Pharmaceuticals Inc. raised $15 million in an inside round from existing investors as it prepares to move its Alzheimer's disease (AD) technology into the clinic. Read More
• Dyax Corp., of Burlington, Mass., reported in its fourth-quarter earnings that net sales of hereditary angioedema drug Kalbitor (ecallantide) increased to $7 million, a 130 percent jump over the fourth quarter of 2010. For the year, Kalbitor sales increased 160 percent to $22.9 million, contributing to the firm's 2011 revenues of $48.7 million. Revenue for the fourth quarter totaled $8.5 million, and the net loss was $13.5 million, or 14 cents per share, marking a slightly wider loss than the 10 cents per share predicted by analysts. Read More
• Can-Fite BioPharma Ltd., of Petah-Tikva, Israel, said the FDA granted orphan drug status to CF102, its candidate in hepatocellular carcinoma (primary liver cancer). Last month, Can-Fite reported results of a Phase I/II study of CF102 suggesting the compound demonstrated a favorable safety profile in a patient population with hepatocellular carcinoma and Child-Pugh cirrhosis Classes A and B. The study also indicated the A3 adenosine receptor, which is the target of CF102, can serve as a biomarker to predict patient response to treatment. CF102 is an orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor. Read More
• Pfizer Inc., of New York, issued a statement regarding the use of Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) in adults, 50 and older. The pharma firm said it believes Prevnar 13 should be recommended for adults in that age group, given the current burden of pneumococcal disease. Read More
• Onyx Pharmaceuticals Inc., of South San Francisco, completed enrollment in the Phase III (ASPIRE) trial of carfilzomib in relapsed multiple myeloma. The trial will compare carfilzomib/lenolidomide/dexamethasone against lenolidomide and dexamethasone in 780 patients with relapsed multiple myeloma at about 200 sites, with a primary endpoint of progression-free survival and secondary endpoints including overall survival, overall response rate, duration of response, disease control rate, safety, time-to-progression and time-to-next-treatment. Read More
