FDA committee recommends expansion of Enbrel age group
NEW YORK A Food and Drug Administration advisory committee voted 8-5 Friday to recommend approval of the drug Enbrel to treat plaque psoriasis in children and teenagers, though the FDA is not required to follow the committee’s recommendation.
Enbrel is already approved to treat plaque psoriasis in adults, as well as arthritis in adults and children. The FDA had expressed concerns about possible life-threatening side effects in children who had received the drug for treating psoriasis, including infections and cancers.
In May, Enbrel got a black box warning about the risk of serious infections that may lead to hospitalization or death.
Enbrel (etanercept), which is marketed by Amgen and Wyeth, had sales of $2 billion in 2007, according to Wyeth financial data.
ShopKo to open in-store clinics in Wisconsin
MADISON, Wis. Meriter, a provider of healthcare services, has teamed up with ShopKo to open two FastCare clinics in Madison in mid-October.
Meriter’s clinics, which will be located in ShopKo East and ShopKo West, will be staffed by nurse practitioners who can offer treatment for such acute ailments as pink eye, bladder infections and skin rashes. The n.p. can write a prescription, if needed.
“We’re very pleased to provide this service to residents, as well as visitors, to our community,” stated Geoff Priest, Meriter chief medical officer. “Providing quality health care that is convenient, both in hours and location, is very important to us at Meriter.”
Green Bay, Wis.-based Bellin Hospital, in partnership with ShopKo, started the FastCare concept. Since then, they have negotiated partnerships with other health care systems, including ThedaCare in Appleton, Aspirus in Wausau and Olmstead in Rochester, Minn. Others underway include Beaver Dam and one in Waukesha.
Alnylam inks potential $93 million deal with Kyowa Hakko Kogyo
CAMBRIDGE, Mass. Alnylam Pharmaceuticals has signed a collaborative deal with Kyowa Hakko Kogyo, that could be worth as much as $93 million, to develop and market the experimental respiratory drug ALN-RSV01, according to the Associated Press.
ALN-RSV01 is currently in midstage development for respiratory syncytial virus, which can cause severe lower respiratory infections, particularly in infants. Most of Alynlam’s pipeline, though, is still in the preclinical phase of development, with potential candidates for liver cancer, Huntington’s disease, pandemic flu, and cystic fibrosis, among others.
This is the company’s second recent deal. At the end of May, Alnylam signed a research partnership deal with Takeda Pharmaceuticals worth as much as $1 billion.