Questions about liver toxicity have dogged Genzyme/Isis’ Kynamro (mipomersen), despite robust LDL-lowering. An FDA panel review in October will tell whether seemingly reassuring safety data from a long-term extension study will do the trick for U.S. approval.
Ionis Pharmaceuticals Inc. will soon find out whether a long-term extension study of its cholesterol drug Kynamro (mipomersen) really puts concerns about liver safety to rest.
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will review the application of Kynamro for homozygous familial hypercholesterolemia on Oct. 18. The session follows the committee’s Oct. 17 review of
Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.
The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.
Two pharmacies, a medical spa and a telehealth company voluntarily removed efficacy, safety and quality claims for compounded GLP-1 products after innovator companies filed challenges with the National Advertising Division.
The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.
A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.
The US Medicare Payment Advisory Commission worries that Medicare prescription drug market trends may cause the stand-alone plan portion of the program to “wither away,” which could take the traditional fee-for-service side of Medicare with it.
The Clinical Trials Access Collaborative (CTAC) will build on a pilot program's work to bolster community-based clinical research infrastructure so "anyone who wants to participate in clinical trials can and do it closer to home,” CEO Tesheia Harris said in an interview.
