FDA Approves Mepolizumab (Nucala) for Severe Asthma

FDA Approves Mepolizumab (Nucala) for Severe Asthma

The drug, T VEC, is a genetically engineered version of the cold sore virus which attacks malignant melanoma, the deadliest form of skin cancer. 28, 2015 (HealthDay News) — A genetically engineered cold sore virus that “blows up” melanoma tumors has been approved by the U.S. The committee did back approval in adults. Imlygic (talimogene laherparepvec), a first-of-its-kind therapy, showed promise against lesions in the skin and lymph nodes in an early trial, the FDA said Tuesday. The new BD ProbeTec HSV Qx Assays offer excellent sensitivity and specificity and a significant improvement in the time-to-results over culture methods, which often take 2-10 days for results. First, it denies them of badly needed medications. EMA Summary of Product Characteristics Linked from EMA Aldara information page ^ PDR Health PDR: Aldara Page accessed June 14, 2015 ^ Walter A, Schäfer M, Cecconi V, Matter C, Urosevic-Maiwald M, Belloni B, Schönewolf N, Dummer R, Bloch W, Werner S, Beer HD, Knuth A, van den Broek M (2013).
FDA Approves Mepolizumab (Nucala) for Severe Asthma

Would a healthy man who understood how diet could be used to prevent, reverse and cure disease be someone who was likely to have a heart attack? The company has a long history of both clinical and regulatory setbacks with the long-delayed testosterone treatment. The agency’s approval is based on a study of 436 patients with advanced melanoma that could not be surgically removed. In addition, patients who received mepolizumab were able to reduce their daily oral corticosteroid dose while keeping their asthma under control compared with patients in the placebo group. Teva expects to make BENDEKA commercially available to prescribers during the first quarter of 2016. Adverse effects most commonly reported by patients taking mepolizumab include headache, injection-site reactions, back pain, and fatigue. The R&D field is littered with oncolytic viruses (“onco” is for cancer and “lytic” is lysis, or bursting) that didn’t make it through the clinical trials.

Darzalex daratumumab Fast Track, Breakthrough, Priority Review, Accelerated Approval Produced in a mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology. Andtbacka said he suspects it’s because the modified herpes virus can only replicate inside cancer cells. Photo: Wesley Wilson / MGN. 331 (d) and 355 (a) , a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it.

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