FDA requests delay on Merck application for cholesterol drugs
BOSTON The Food and Drug Administration has recommended that Merck wait until it finishes clinical trials of the cholesterol drugs MK-0524A and MK-0524B before re-filing a marketing application for them, Merck announced Friday.
The FDA rejected Merck’s application for the two drugs in April, and the FDA has advised that it should wait until it receives results from the clinical trial before re-filing.
MK-0524A is a combination of the drug Cordaptive and niacin; MK-0524B combines those ingredients with Zocor. Merck has said it does not plan to seek approval for MK-0524B until it completes the application for MK-0524A.
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.