Top Regulatory News Stories – Week Ending September 6, 2019

Two decades after launching clinical trials, Kyowa Hakko Kirin finally received FDA approval for add-on Parkinson’s therapy  https://endpts.com/decades-into-the-making-kyowa-hakko-kirin-wins-fda-approval-for-add-on-parkinsons-therapy/?utm Mylan won tentative US approval for generic version of Lilly’s Alimta, but it could be years before it can be sold.  https://endpts.com/mylan-wins-tentative-us-approval-for-generic-version-of-lillys-alimta-but-it-could-be-years-before-its-sold/ CARsgen Therapeutics Inc. announced the FDA has granted orphan drug designation to its investigational CAR-T[…]

Top Regulatory News Stories – Week Ending August 23, 2019

AbbVie announced that the U.S. FDA has approved RINVOQ™ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR).  https://www.prnewswire.com/news-releases/abbvie-receives-fda-approval-of-rinvoq-upadacitinib-an-oral-jak-inhibitor-for-the-treatment-of-moderate-to-severe-rheumatoid-arthritis-300903053.html Nabriva Therapeutics announced that the FDA has approved the oral and[…]

Top Regulatory News Stories – Week Ending August 16, 2019

Harmony Biosciences announced today that the FDA approved WAKIX® (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. WAKIX is the first and only treatment approved for patients with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration (DEA).  https://finance.yahoo.com/news/harmony-biosciences-announces-fda-approval-120000845.html The FDA has approved[…]

Top Regulatory News Stories – Week Ending August 9, 2019

Daiichi Sankyo announced that the US FDA approved TURALIO™ (pexidartinib) as the first and only treatment for adult patients with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery.  https://www.prnewswire.com/news-releases/fda-approves-daiichi-sankyos-turalio-pexidartinib-for-the-treatment-of-select-patients-with-tgct-a-rare-and-debilitating-tumor-300895924.html Last week the FDA approved Bayer’s Nubeqa® (darolutamide), a new treatment for men with non-metastatic castration-resistant prostate cancer.[…]

Top Regulatory News Stories – Week Ending August 2, 2019

Celgene received FDA approval for Otezla to treat oral ulcers associated with Behçet’s Disease. https://www.pharmaceutical-business-review.com/news/celgene-otezla-behcets-disease/ Apic Bio, Inc. announced that the FDA has granted orphan drug designation to APB-102, a gene therapy soon to be in clinical development for the treatment of genetic SOD1 amyotrophic lateral sclerosis (ALS).  http://www.firstwordpharma.com/node/1654288#axzz5uQCOiPcE Biohaven Pharmaceuticals reported that the FDA[…]

Top Regulatory News Stories – Week Ending July 19, 2019

Cellectar Biosciences announced the FDA has granted Fast Track Designation for CLR 131 in relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL).  https://www.globenewswire.com/news-release/2019/07/09/1880139/0/en/Cellectar-Receives-FDA-Fast-Track-Designation-for-CLR-131-in-Diffuse-Large-B-Cell-Lymphoma.html Dicerna Pharmaceuticals announced that the FDA has granted a Breakthrough Therapy Designation (BTD) to DCR-PHXC for the treatment of patients with primary hyperoxaluria type 1 (PH1). https://www.businesswire.com/news/home/20190715005117/en/Dicerna-Receives-Breakthrough-Therapy-Designation-DCR-PHXC-Treatment/?feedref=JjAwJuNHiystnCoBq_hl-WFAllVCLJFCqzlmaJ8DKHU4plfPZtlGYRDUHCSmgbii6XkLWuQZD-HgGRnjQvCyg3iCfEFIaJW7-otp9V1XQiK2eHTJy3ZqOEt7kKgLu20J Neurocrine Biosciences said the FDA[…]