Apotex faces patent infringement suit over allergy inhaler
NEW YORK Canadian generic drug maker Apotex faces a patent infringement lawsuit over its efforts to win Food and Drug Administration approval for a generic version of an allergy inhaler, according to published reports.
Bloomberg reported that Schering-Plough Corp., recently acquired by Merck & Co., was suing Apotex in the U.S. District Court for the District of New Jersey over its generic version of Nasonex (mometasone furoate monohydrate).
Under the Hatch-Waxman Act of 1984, a branded drug maker can sue a generic drug maker for patent infringement when the generic manufacturer seeks regulatory approval for its version of a drug and files a Paragraph IV certification, which asserts that its approval application does not infringe on the branded company’s patents or that the patents are unenforceable. Such a lawsuit prohibits the FDA from granting final approval to the drug for 30 months or until the generic drug maker wins the suit.
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.”