News Commentary | April 03, 2020
The key thing about this development is that Pear Therapeutics submitted to the FDA for approval via two separate pathways – the precertification pathway, and the more traditional 510(k) pathway. The precertification pathway was expected because digitial therapeutics are the reason that it exists, ... To read more, click here.
Case Study | April 21, 2020
COVID‑19, caused by SARS‑Cov‑2, has transformed daily life across the globe in a few short months and has unleashed a scientific race to restore the economy and save patients. With the speed of COVID‑19's spread and its associated social and economic impact, an effective and speedy solution is ... Not part of subscription
Analyst Insight | June 08, 2021
Biogen's recent FDA approval for an Alzheimer's disease (AD) drug is arguably the biggest news this week in the healthcare industry. Both Biogen's and its development partner Eisai's stock prices jumped more than 50% on the announcement. Yet, many dementia experts were quick to point out that the ... Not part of subscription
by Nardev Ramanathan
Multiple new and emerging COVID-19 variants with higher transmission rates have thrown into question the continued efficacy of existing vaccines across these newer strains. Previous research has focused on the receptor-binding domain (RBD) given its importance in attaching to and infecting human cells. This study, however, found that 84% of circulating antibodies from recovering COVID-19 patients were in fact targeting areas outside the RBD, and some were targeting parts of the virus that are not easily mutable. Next-generation vaccine design could focus on amplifying these antibodies. One limitation is that the study was based on blood plasma samples from four patients; a larger sample size is needed to validate this observation.
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