Teva: Lou Gehrig’s disease treatment trial did not meet endpoints
JERUSALEM An investigational drug made by Teva Pharmaceutical Industries was not effective in patients with Lou Gehrig’s disease, according to results of a mid-stage clinical trial announced Monday.
Teva said the 559-patient phase 2 “ALSTAR” study showed the drug talampanel to be safe, but not effective in patients with the disease, also known as amyotrophic lateral sclerosis. Lou Gehrig’s disease is a degenerative motor neuron disease that leads to paralysis and death, usually within three to five years of onset.
“Despite our hopes to advance the treatment of this debilitating disease, talampanel did not succeed in demonstrating the required efficacy, although safety was established,” Teva group VP global branded products Moshe Manor said. “Broadening our innovative pipeline – through internal R&D, licensing and other business development activities – is part of our long-term strategy.”
Teva receives tentative approval for generic Sensipar
JERUSALEM The Food and Drug Administration has granted tentative approval to Teva Pharmaceutical Industries’ generic version of an Amgen drug, Teva said Friday.
The FDA gave the tentative approval to cincacalcet hydrochloride tablets in the 30-mg, 60-mg and 90-mg strengths. The drug is a generic version of Amgen’s Sensipar, which has annual sales of $458 million, according to IMS Health. The drug is used to treat secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
Tentative approval means that the drug meets most of the conditions for approval, but the FDA cannot grant final approval because the patents covering the drug don’t expire until December 2016, according to FDA records. Teva and Amgen are currently involved in patent litigation concerning the drug in the U.S. District Court for the District of Delaware, though a trial has not been set, Teva said.
RediClinic introduces Teen Health Package
HOUSTON RediClinic is launching in time for summer camp and upcoming school sports a new health package designed specifically for teenagers.
The new Teen Health Package includes a physical exam, an acne consultation and an immunization review for $59.
"We all know that adolescence is a time of great change," stated Susan Cooley King, VP clinical services. "With this in mind, RediClinic created a special health package that addresses the specific health needs of a teen."
Physical exams are always in season. They are required by summer camps and for participation in school sports. During a RedlClinic physical, a clinician evaluates the teen’s medical history. The exam is then performed, checking their physical health including, but not limited to, chest and heart, lymph nodes, blood pressure and abdomen.
Patients of the Teen Health Package also will receive an evaluation of their acne issues and the clinician will make recommendations for the most appropriate treatment ranging from over-the-counter medications to prescriptions.
According to the American Academy of Dermatology, 85% of American teenagers are effected by acne.
Patients also will receive an immunization review whereby the clinician will review the teen’s immunization history, identify which vaccines the patient needs for school admission and administer the vaccines, for an additional charge if necessary.