Arena seeks FDA approval for weight-loss drug
SAN DIEGO Arena Pharmaceuticals has submitted a regulatory approval application to the Food and Drug Administration for a weight-control drug, the drug maker announced Tuesday.
Arena submitted the new drug application for lorcaserin, designed to help patients lose and manage weight. The submission is based on 18 clinical trials of 8,576 patients.
“Physicians need new, better-tolerated approaches to improve the treatment of patients who are obese or significantly overweight,” Arena VP and chief medical officer William Shanahan said. “Based on the robust data package we submitted to the FDA, lorcaserin has the potential to meet this need, offering patients the opportunity to achieve sustainable weight loss in a well-tolerated manner and improve their cardiometabolic health and quality of life.”
New report questions glucose self-monitoring among noninsulin-dependent Type 2 diabetes patients
NEW YORK There’s no proof that self monitoring of blood glucose by Type 2 diabetes patients not dependent on insulin produces any benefits, according to a recent report by a German healthcare analysis organization.
The Institute for Quality and Efficiency in Health Care also said in its report that it remained unclear whether blood tests had an advantage over urine tests. Blood glucose monitoring remains important for Type 1 and Type 2 patients who do inject insulin, the report noted.
The report by IQWiG — the organization bases its acronym on its German name — used six trials, but came to the conclusion that the data from the trials were not enough to draw any conclusions on the long-term benefit of glucose self-monitoring among noninsulin-dependent Type 2 diabetes patients.
Former CDC head assumes new role at Merck’s vaccine division
WHITEHOUSE STATION, N.J. The former head of the Centers for Disease Control and Prevention will soon start work as the new president of Merck & Co.’s vaccine division.
Merck announced Monday that it had appointed Julie Gerberding as president of Merck Vaccines, effective Jan. 25. Gerberding was director of the CDC from 2002 to 2009, having led the agency through more than 40 emergency response initiatives for health crises.
“Vaccines are a cornerstone of Merck’s commitment to health and wellness,” Merck chairman and CEO Richard Clark said. “We are delighted to welcome an expert of Dr. Gerberding’s caliber to Merck.”