FDA tentatively approves Matrix Labs’ HIV treatment
PITTSBURGH The Food and Drug Administration has given tentative approval to a subsidiary of Mylan under the President’s Emergency Plan for AIDS Relief for a drug to treat HIV in children, Mylan announced Tuesday.
The FDA gave the tentative approval for Matrix Labs’ new drug application for efavirenz tablets in the 50-mg, 100-mg and 200-mg strengths. The drug is a non-nucleoside reverse transcriptase inhibitor used to treat HIV infections in patients whether they have received prior treatment or not.
“This new drug application represents another successful innovation by Matrix in the fight against HIV/AIDS,” Mylan president Heather Bresch said in a statement. Our HIV/AIDS antiretroviral franchise continues to grow and to bring more affordable, high-quality medications to patients in the developing world.”
The tentative approval under PEPFAR means that the drug meets FDA requirements for approval. While existing patents and exclusivity prevent Matrix from marketing it in the United States, it will be available in many developing countries. Bristol-Myers Squibb Co. markets efavirenz in the United States under the brand name Sustiva.
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.”