FDA approves drug for auto-inflammatory disease
ROCKVILLE, Md. The Food and Drug Administration has approved a new biotech drug for treating a chronic inflammatory disease.
The FDA announced Thursday the approval of Novartis’ Ilaris (canakinumab) for the treatment of cryopyrin associated periodic syndrome in children and adults. The hereditary disease, for which limited treatments exist, includes such rare, but life-long and debilitating, symptoms as fatigue, headaches and, in the long term, deafness, bone deformities, nervous system damage and death.
“Until now, treatments for CAPS patients have been limited to traditional inflammatory-disease medications that work by suppressing the entire immune system, and newer therapies that control the disease better but require more frequent injections,” University of California San Diego professor of pediatrics and medicine Hal Hoffman said in a Novartis statement.
Covidien enters a license, development collaboration with Nuvo Research
ST. LOUIS A healthcare products company hopes to expand its entry into the branded painkiller market through a new deal with a Canadian drug development company.
Covidien announced that it had entered a license and development collaboration with Mississauga, Ontario-based Nuvo Research, which develops transdermal and topical drugs. The collaboration includes a topical painkiller that combines the nonsteroidal, anti-inflammatory drug diclofenac sodium with the transdermal carrier dimethyl sulfoxide.
Covidien said that Nuvo would receive an upfront payment – which Covidien would expense in its fiscal third quarter – development and sales milestone payments and royalties.
APhA ‘stands ready’ for reformed healthcare system
WASHINGTON An organization representing the country’s pharmacists heralded comments by President Barack Obama before the American Medical Association Monday that mentioned members of the profession as playing a role in healthcare reform.
Pharmacists “stand ready” to be part of a reformed healthcare system, the American Pharmacists Association said in response.
The APhA said that evidence increasingly indicates pharmacists help keep healthcare costs in check through such services as medication therapy management, which includes educating patients on how to take prescription drugs properly and safely, and health screenings and immunizations.
“We need to build on the examples of outstanding medicine at places like the Cincinnati Children’s Hospital, where the quality of care for cystic fibrosis patients shot up after the hospital began incorporating suggestions from parents,” Obama said in his remarks before the AMA’s annual conference in Chicago. “And places like Tallahassee Memorial Health Care, where deaths were dramatically reduced with rapid response teams that monitored patients’ conditions and ‘multidisciplinary rounds’ with everyone from physicians to pharmacists.”