A new study by Mayo Clinic and Nference Inc. researchers suggests that prior childhood and adult vaccinations for illnesses such as polio, measles and flu may provide protection against COVID-19 infection. The study, which analyzed patient data using Nference artificial intelligence (AI) software, underscores the critical role immunizations play in curbing the spread of diseases and preventing future pandemics. “What we discovered represents compelling evidence that vaccinations are a critical element in prevention of disease, even diseases one doesn’t anticipate,” said Venky Soundararajan, co-founder and chief scientific officer of the Cambridge, Mass.-based company.
Drug and device companies dragging their feet on diversifying late-stage clinical trials could conceivably get a wake-up call in court or in FDA approval delays.
Liver disease specialist Ascletis Pharma Inc. said its nonalcoholic steatohepatitis (NASH)-focused subsidiary, Gannex Pharma Co. Ltd., will start global development of its oral THR-β agonist, ASC-41, after it obtained an IND approval from the FDA based on positive phase I data generated in China.
A failure of Tricida Inc.'s most recent efforts to overcome FDA objections to an NDA for the company's sole candidate, veverimer, for treating metabolic acidosis, sent company shares (NASDAQ:TCDA) 30.6% lower to $5.11 on Feb. 26. The complex story appears focused now on the agency's desire for additional and more reliable data to support a potential approval. Tricida President and CEO Gerrit Klaerner on Thursday suggested the ongoing renal outcomes study, Valor-CKD, might provide it.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amgen, Arbutus, Assembly, Astrazeneca, Innovation, Partner, Pharvaris, Revive, XNK.
Drug and device companies dragging their feet on diversifying late-stage clinical trials could conceivably get a wake-up call in court or in FDA approval delays. A final guidance the FDA released in November suggests that the days of ignoring segments of the intended treatment population until safety signals flare in real-world use are coming to an end.
In 2020, Appliedvr Inc. reported results from a three-week proof-of-concept study showing reduction of lower back pain with the use of its Easevrx virtual reality (VR) therapy. Now the company has pivotal data affirming the benefit to patients with chronic low back pain who used Easevrx at home for eight weeks.
Pfizer Inc. and Biontech SE submitted new data to the FDA showing its COVID-19 vaccine’s stability can be maintained at temperatures often found in pharmaceutical freezers and refrigerators: -13°F to 5°F (-25°C to -15°C).
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