Sanofi (NYSE:SNY) and Regeneron (NSDQ:REGN) said today that the FDA approved the companies’ new supplemental Biologics License Application for a once-monthly, 300 milligram dose of Praluent as a treatment for adults with high low-density lipoprotein cholesterol. The 300 milligram dose is administered using 2 pre-filled pens that each deliver 150 milligrams at an injection site. The […]
Food & Drug Administration (FDA)
How medtech companies can benefit from agile marketing
Getting a medical device to market can be tough. It has to go through several hoops at the FDA, including the 5-step premarket requirements that include: classifying the device; choosing the correct premarket submission; preparing appropriate information for premarket FDA submission; sending a premarket submission to the FDA and communicating with FDA staff during review; and […]
Improving the safety of imported foods through partnerships
By: Susan Mayne, Ph.D., Camille Brewer, M.S., R.D., and Donald Prater, D.V.M. At FDA, we recognize that the partnerships we build with other nations are key to our success in giving American consumers confidence in the safety of the foods they choose to serve their families. In passing the FDA Food Safety Modernization Act (FSMA), […]
Medtech stories we missed this week: April 21, 2017
From new and renewed partnerships to FDA approvals, here are medtech stories we missed this week but thought were still worth mentioning. 1. Life Spine receives FDA clearance for cervical spacer system Life Spine announced in an April 19 press release that it has received FDA 510(k) clearance for its Plateau-C Ti Cervical Spacer System. The system uses […]
23andMe is back: FDA allows marketing of genetic health risk tests
FDA this month allowed genetic testing company 23andMe to market genetic health risk tests for 10 diseases and conditions including Parkinson’s disease and late-onset Alzheimer’s disease. The de novo premarket review authorization, announced April 6, also included celiac disease, which results in the inability to digest gluten; alpha-1 antitrypsin deficiency, which raises the risk of […]
America’s Got Talent – regulatory science style
By: Stephen Ostroff, M.D. Veni Vidi Vici. It translates into English as “I came, I saw, I conquered.” It also happens to be the name chosen by one of the winners of the recently held America’s Got Regulatory Science Talent Competition. FDA recognizes that young scientists are our future. Now in its fifth year, America’s Got Regulatory […]
Medtech stories we missed this week: April 14, 2017
From FDA approvals to business expansion plans, here are medtech stories we missed this week but thought were still worth mentioning. 1. BioTelemetry launches offer to acquire LifeWatch BioTelemetry and LifeWatch announced in an April 9 press release that the 2 companies have entered a transaction agreement that states BioTelemetry will launch a tender offer to acquire all […]
Cytori wins FDA nod for cell therapy pilot trial
Cytori Therapeutics (NSDQ:CYTX) said today that the FDA approved an Investigational Device Exemption for a pilot trial of the company’s cell therapy in patients with thermal burn injury. The Relief trial is a part of Cytori’s ongoing R&D efforts under its contract with the U.S. Dept. of Health & Human Services’ Biomedical Advanced Research and […]
SteadyMed studies accuracy and precision of PatchPump infusion system for Trevyent
SteadyMed (NSDQ:STDY) said yesterday that it finished a clinical study for its lead drug candidate, Trevyent. The pulmonary arterial hypertension treatment is a combination of treprostinil and the PatchPump prefilled, disposable infusion system. The San Ramon, Calif.-based company said it is on track to submit a New Drug Application for Trevyent in the 2nd quarter […]
United delays Remosynch launch until 2018
Shares in United Therapeutics (NSDQ:UTHR) fell -7% this morning to $126.17 apiece after the company said that the U.S. commercial launch of Remosynch, Medtronic‘s (NYSE:MDT) implantable infusion pump for Remodulin, will be delayed until 2018. “United Therapeutics’ commitment to bringing better therapies to patients transcends temporary delays or setbacks,” United chairman & CEO Martine Rothblatt said in […]