This is our Regulatory Landscape newsletter for September 2023 with our monthly insights on the evolving market for Regulatory professionals. For the month of August there were about 80 new Regulatory positions posted at smaller biotech and pharma companies in the US. This is up about 14% from last month and very similar to the[…]
Pay transparency is coming to the biopharma industry. In fact, there’s already some form of law in place in California, Colorado, Connecticut, Maryland, and Washington with new transparency laws enacting in New York on November 1, 2022. Job boards such as Indeed are seeing an increase in companies sharing salary ranges. LinkedIn’s latest Workforce Confidence[…]
In today’s market, it’s incredibly challenging to find the desired Regulatory talent for growing bio/pharma organizations. We’ve seen companies adjust levels, rapidly promote people, and lower their expectations. It’s an arduous process but once you finally are ready to make an offer, it’s becoming increasingly difficult to get the acceptance. The biggest challenge is that[…]
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[…]
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[…]
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[…]
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[…]
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[…]
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[…]
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[…]
