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What We’re Reading: FDA Reviews ALS Drug; Vaccines Lower Long COVID-19; New COTA President, CEO


The FDA accepts an application for a drug to treat amyotriphic lateral sclerosis (ALS) for review; vaccines have been found to reduce people’s risk for developing long COVID-19; COTA announces Miruna Sasu, PhD, as its new president and CEO.

FDA Reviews ALS Therapy After Patient Concerns

After the controversial approval of Aduhelm (aducanuma) for Alzheimer disease, the FDA may soon approve another medication for the treatment of amyotriphic lateral sclerosis (ALS) based on partial data, according to The Associated Press. The FDA will meet next week for a public review of data from a small, mid-stage study of AMX0035, which was developed by Amylyx Pharmaceuticals. The company submitted its approval application for the drug prior to completing a large, confirmatory study after months of lobbying by patients with ALS and congressional leaders. Similarly with the approval of Aduhelm, there are concerns that the FDA is bucking under pressure from advocacy groups and pharmaceutical interests to review drug applications without meeting its standard requirement of 2 large, late-stage studies.

Vaccines Found to Lower Risk of Long COVID-19

A growing body of evidence is showing that the risk of a mild case of COVID-19 turning into a long-term medical condition is significantly reduced for people who have been vaccinated against the virus compared to unvaccinated individuals, according to NPR. Although many of the results are preliminary, the handful of studies that have emerged recently have had consistent findings. There are some theories as to why infected people develop long COVID-19, including the potential for permanent tissue damage, injury to blood vessels, and the development of microclots during infection. The evidence has shown that someone who is vaccinated has less virus in their body during an infection so it’s possible that the amount of virus-related complications is lower for vaccinated, infected people as well.

Former J&J Executive Becomes New President, CEO of COTA

Former Johnson & Johnson (J&J) executive Miruna Sasu, PhD, MBA, has been appointed as the company’s new president and CEO, according to a statement published by COTA. In her new role, Sasu will lead adoptions efforts of real-world data by the life sciences industry to accelerate drug development and reduce prescription costs. She will also be tasked with prioritizing strategic provider and clinical research partnerships that support evidence-based standards of care to promote the advancement of patients outcomes, improve health equity for all patients with cancer, and drive down costs of care. Sasu has been a part of COTA since April 2021, when she was hired as a chief strategy officer.

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