FDA has announced approval of Eli Lilly’s Emgality (galcanezumab-gnlm), the first treatment for episodic cluster headache that reduces the frequency of attacks. Decision was made based on a clinical trial that compared the drug to placebo in 106 patients, and found that during a three-week period, patients taking Emgality experienced 8.7 fewer weekly cluster headache
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FDA has given Breakthrough Therapy Designation to Bayer’s PI3K inhibitor Copanlisib for marginal zone lymphoma (MZL) patients who have received two prior therapies. MZL is an indolent form of non-Hodgkin’s Lymphoma (iNHL) and accounts for approximately 10% of all non-Hodgkin’s Lymphoma cases in the US. The designation was based on data from a MZL subgroup
Akcea Therapeutics’ Inotersen has received recommendation from NICE, meaning the therapy will now be made available to NHS patients in England and Wales for the treatment of Stage 1 or Stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR). hATTR is a serious condition caused by “the abnormal formation of the TTR protein