Top Regulatory News Stories – Week Ending September 27, 2019

Bavarian Nordic announces U.S. FDA approval of JYNNEOS™ (Smallpox and Monkeypox Vaccine) for prevention of Smallpox and Monkeypox disease in adults.  https://www.globenewswire.com/news-release/2019/09/24/1920224/0/en/Bavarian-Nordic-Announces-U-S-FDA-Approval-of-JYNNEOS-Smallpox-and-Monkeypox-Vaccine-Live-Non-replicating-for-Prevention-of-Smallpox-and-Monkeypox-Disease-in-Adults.html Novo Nordisk’s Rybelsus, an oral-semaglutide for type 2 diabetes snagged approval from the U.S. FDA, marking it as the first such treatment to be approved in pill form.    https://www.biospace.com/article/novo-nordisk-snags-fda-approval-for-oral-type-2-diabetes-drug/ Johnson & Johnson’s multiple[…]

Top Regulatory News Stories – Week Ending September 20, 2019

Ardelyx, Inc. announced that the U.S. Food and Drug Administration has approved IBSRELA® (tenapanor), a 50 mg, twice daily oral pill for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.  https://www.prnewswire.com/news-releases/ardelyx-receives-fda-approval-for-ibsrela-tenapanor-an-nhe3-sodium-transport-inhibitor-for-the-treatment-of-irritable-bowel-syndrome-with-constipation-300917407.html Amplyx Pharmaceuticals announced that the FDA has granted Fast Track designations for both the intravenous (IV) and oral formulations of the[…]

Top Regulatory News Stories – Week Ending September 13, 2019

Five years after securing its first approval in idiopathic lung fibrosis,  Boehringer Ingelheim’s drug Ofev has been cleared to slow the rate of pulmonary decline in patients with another lung scarring disease. https://endpts.com/boehringer-ingelheims-ofev-wins-fda-approval-for-use-in-scleroderma-patients/ Ridgeback Biotherapeutics announced that the Food and Drug Administration has recently granted mAb114, an experimental treatment for Ebola, Breakthrough Therapy designation. https://www.prnewswire.com/news-releases/ridgeback-biotherapeutics-lp-announces-receipt-of-breakthrough-therapy-designation-from-fda-for-mab114-300913398.html[…]

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 12, 2019

Karyopharm Therapeutics announced that the U.S. FDA has approved oral XPOVIOTM (selinexor), a nuclear export inhibitor, in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM). https://www.globenewswire.com/news-release/2019/07/03/1878060/0/en/Karyopharm-Announces-FDA-Approval-of-XPOVIO-selinexor-for-the-Treatment-of-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma.html Alexion’s Soliris received FDA approval for an additional indication last week.  The drug is now approved to treat neuromyelitis optica spectrum[…]

Top Regulatory News Stories – Week Ending June 21, 2019

Blueprint Medicines announced it has submitted a NDA to the FDA for avapritinib for the treatment of adult patients with PDGFRA Exon 18 mutant gastrointestinal stromal tumors (GIST), regardless of prior therapy, and fourth-line GIST.  https://www.drugs.com/nda/avapritinib_190614.html?utm_source=ddc&utm The FDA announced that generic drug applicants will now have access to more information from the agency when deciding[…]