Regulatory Landscape Newsletter – August 2020

This is our Regulatory Landscape newsletter for August 2020 with our monthly insights on the evolving market for regulatory professionals.  Regulatory hiring remained strong for the month of July with over 100 new regulatory positions posted across the country.  Most of these positions were in clinical regulatory strategy and regulatory CMC along with several new[…]

COVID-19 Update: Observations from a Regulatory Recruiter

The COVID-19 outbreak is affecting both individuals and businesses in a variety of ways.  As a Regulatory Recruiter for the biopharma industry, I speak with both hiring authorities and regulatory professionals every day, and I wanted to share some insights on what I have been hearing over the past week. Some biopharma companies are moving[…]

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[…]