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Pharma, life science and medical news Aug 1st week



USFDA approves Bayer’s darolutamide for Prostate Cancer.

U.S. Food and Drug Administration has approved new prostate cancer drug daroluramide.

Darolutamide is a nonsteroidal antiandrogen – specifically, a selective antagonist of the androgen receptor.

The U.S. Food and Drug Administration has approved darolutamide, under the brand name Nubeqa, for the treatment of patients with non-metastatic castration-resistant prostate cancer. 

FDA approves Samsung Bioepis’s Hadlima, fourth Humira biosimilar.

Healio reports the FDA has approved the fourth biosimilar to adalimumab, for all eligible indications of the biologic product, according to a company press release.

Hadlima (of Samsung Bioepis), a biosimilar to Humira (of AbbVie), is a TNF inhibitor intended to treat patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.

Hadlima is the fourth biosimilar to Humira to gain FDA approval in the United States, following Hyrimoz (of Sandoz) in 2018, Cyltezo (of Boehringer Ingelheim) in 2017 and Amjevita (of Amgen) in 2016.

Zydus Cadila has received final approval for acne drug from FDA.

Zydus Cadila has received final approval from the US health regulator to market minocycline hydrochloride extended release tablets used to treat acne, Zydus Cadila said in a BSE filing on 02nd Aug 2019.

Minocycline hydrochloride extended release tablets are indicated to treat only inflammatory lesions of non-modular moderate to severe acne vulgaris in patients of 12 years of age or older.

U.S. FDA approves Daiichi Sankyo’s Turalio for rare joint tumor.

Reuters reported that The U.S. Food and Drug Administration on Friday approved Daiichi Sankyo Co Ltd’s treatment for adult patients with a debilitating rare condition called tenosynovial giant cell tumor, which is a non-cancerous tumor affecting joints and limbs.

The label for the treatment, Turalio, includes a boxed warning flagging the risk of serious and potentially fatal liver injury.

Turalio is the first approved therapy in the United States for tenosynovial giant cell tumor, the primary treatment of which has so far been surgery.

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