Our Tips for Enduring The COVID Lockdown

For the past six weeks, we have been working from home and under a “stay at home” order in Massachusetts.  This has kept us from our normal routines and extracurricular activities. Here are some of the things we have been doing to keep us sane: Video meetings.  We do daily team video meetings to stay[…]

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[…]