Drug Development
In this episode of Denatured, Jennifer C. Smith-Parker speaks to Erik Digman Wiklund, CEO of Circio and Jacob Becraft, Co-founder and CEO of Strand Therapeutics. They discuss how post-COVID, emerging platforms like circular and logic circuit RNA are expanding the field’s therapeutic horizons.
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After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
AstraZeneca’s $15 billion pledge to its China operations highlights the country’s advantages. But other regions are also hoping to host more clinical studies.
With Lykos’ regulatory failure now squarely in the rearview mirror, Compass Pathways and Definium are leading what one analyst suspects will be “a very big year for psychedelics.”
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A current Phase III trial of the Pfizer-BioNTech COVID-19 vaccine has confirmed the protection remains high for at least six months after the second dose. In a statement, Pfizer and BioNTech reported the vaccine was 91.3% effective against the disease.
A manufacturing mistake at Emergent Biosolutions ruined a 15 million-dose batch of Johnson & Johnson’s Vaxzevria in production.
Will We Need COVID-19 Vaccines Every Year? Although the jury is still out, a study out of Charité – Universitätsmedizin Berlin suggests that the answer is yes for a few years, but may be unnecessary after a few years post-pandemic.
Several new reports, two by the U.S. CDC, describe just how severely COVID-19 has affected mortality figures in the U.S., and around the world, as well as ripple effects that extended to other forms of death.
Three members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee published their objections to the drug in a JAMA article.
The two companies announced data from a Phase III study which showed 100% efficacy and robust antibody responses in patients ages 12 -15 who received the BNT162b2 vaccine.
Citing Russia’s agricultural regulatory agency, Reuters reported the new vaccine called Carnivac-Cov will be used against the virus in dogs, cats, foxes and mink.
The first four patients that were administered BS01, Bionic Sight’s investigational gene therapy for advanced retinitis pigmentosa (RP), all reported the ability to detect light and motion. Two of the patients were also able to detect direction.
Disappointing data from two Phase Ib/IIa trials for both lead Huntington’s disease antisense candidates have pushed Wave Life Sciences to shelve the assets and focus on its next generation of therapies.
AbbVie won the NDA on the strength of definitive results in a Phase III ADVANCE trial, where atogepant met all six secondary endpoints at the 30-60 mg dose range, proving statistically significant in heading off migraines in nearly 2500 adult participants who experience them between 4-14 days per month.