Amgen (AMGN) has been granted FDA approval for its cholesterol-lowering medication, Repatha (evolocumab) Injection. The drug is expected to be available in the U.S. next week.
Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood.
According to the company, Repatha is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C.
The U.S. Wholesale Acquisition Cost price of Repatha is $542.31 for one 140 mg single-use prefilled SureClick autoinjector or prefilled syringe, or $14,100 annually for the every two weeks administration, noted the company.
AMGN closed Thursday's trading at $155.72, up 1.13%.
Applied Genetic Technologies Corp.'s (AGTC) phase I/II clinical trial of gene therapy product candidate for the treatment of X-Linked Retinoschisis is expected to enroll a total of 27 patients at four sites, and preliminary data from the first cohorts of patients are expected by the end of 2015.
Stay tuned…
AGTC closed Thursday's trading at $15.90, up 2.71%.
DigiPath Inc. (DIGP.OB) announced that the medical marijuana safety and potency testing services of its cannabis testing subsidiary DigiPath are generating revenue as medical marijuana dispensaries open in Nevada.
The company's flagship testing lab is in Nevada, the state with the most stringent testing requirements in the nation.
DIGP.OB closed Thursday's trading at $0.23, up 17.50%.
The FDA has approved Boehringer Ingelheim Pharmaceuticals Inc. and Eli Lilly and Co.'s (LLY) Synjardy tablets for the treatment of adults with type 2 diabetes.
Synjardy is a combination of empagliflozin and metformin - two medicines with complementary mechanisms of action - to help control blood glucose in people with type 2 diabetes. The drug was also recently approved by the European Medicines Agency in May 2015.
LLY closed Thursday's trading 3.26% higher at $83.74.
Threshold Pharmaceuticals Inc. (THLD) has initiated a phase II clinical trial of its drug candidate tarloxotinib bromide for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck or skin.
The study, designed to enroll up to 68 patients, will open at 10 sites in the U.S. and Australia.
THLD closed Thursday's trading at $4.25, up 3.41%.
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