Join Dr. Jim Neuenschwander and the CE Symmetry team on February 17, 2021 at 3:00 PM EST / 2:00 PM CST for an informative session on the role of the biomarker assay procalcitonin in the management of antimicrobial therapy. Dr. Neuenschwander will review procalcitonin assay…
The percentage of physicians receiving payments from pharma and device companies has decreased since implementation of the Open Payments database in 2014. A report recently published in JAMA highlighted changes resulting from the 2014 launch of the Open Payments database. The percentage of physicians who…
Once again, Dr. Fauci provides solid and pragmatic information and guidance. Story by By Elisabeth Rosenthal NOVEMBER 19, 2020 KHN As a health journalist, a physician and a former foreign correspondent who lived through SARS in Beijing, I often get questions from friends, colleagues and people…
Cambridge, Mass.-based Moderna announced that its COVID-19 vaccine candidate, mRNA-1273, demonstrated 94.5 percent efficacy in early results from a phase 3 trial. The interim analysis, based on 95 positive COVID-19 cases, found that only five of the participants who tested positive had received the vaccine,…
This is exciting news from one of our past clients. CE Symmetry’s sister company, MedCom Collaborative, planned and executed the Investigators’ Meeting for their Phase III clinical trials in 2014. It is great to see the hard work and all of the efforts of Vern…
Yesterday, the FDA announced the approval of Amgen’s Avsola (infliximab-axxq). This is the fourth biosimilar approved by the FDA for the immunosuppressive drug from Janssen, Remicade (infliximab). Avsola IV was approved for treatment of Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, rheumatoid arthritis and psoriatic…
Ned Sharpless, the acting FDA Commissioner, reiterated the agency’s interest in patient engagement and data collection with regard to rare disease therapies. This is a good omen for patients with diseases like Hereditary Angioedema (check out the US HAEA site here). “To most effectively support…
Trikafta, the first triple combination therapy available, was approved this week by the FDA for patients 12 years and older with cystic fibrosis who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. This is estimated to be 90%…
After further analysis of data collected after the interim assessment, Biogen has decided to file for FDA approval of aducanumab, the thought dead Alzheimer’s drug that failed a futility analysis in March. Biogen share price has been on a steady climb since the announcement this…
Merck & Co. plans to lay off approximately 500 U.S.-based employees working on sales and commercial teams, the company disclosed Thursday in a regulatory filing and confirmed Friday to BioPharma Dive. Click here to check out the article on BioPharma Dive.