Regulatory
The first RSV antibody is on its way
Within weeks of approving the first vaccines for RSV, the FDA appears on its way to clearing an antibody treatment meant to protect newborns and young children from the virus.
As STAT's Helen Branswell reports, a panel of expert advisers to the FDA voted in favor of Beyfortus, an antibody developed by AstraZeneca that will be marketed by Sanofi. In the first vote, the group unanimously supported using the medicine for children in the first year of life. In the second, members voted 19-2 to recommend its approval for high-risk kids in their second year.
Beyfortus is part of a sea change in the prevention of RSV, a virus that is particularly dangerous to young children and the elderly. In May, the FDA approved two vaccines, from Pfizer and GSK, for adults over the age of 60. Pfizer is also asking for its vaccine to be approved for use during pregnancy to protect newborns from infection.
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R&D
AI can't don a lab coat, but it can invent a drug
And that creates a problem for U.S. patent law.
As STAT's Brittany Trang reports, under current regulations, the registered inventors of novel things have to be human beings, meaning an AI-designed medicine would be unpatentable. That disincentivizes drug developers from using the latest technological tools to find new medicines, industry representatives said at a congressional hearing yesterday.
Novartis, for example, is already using a generative chemistry AI platform that was able to generate 282 antimalarial drug candidates, two of which seem to fight malaria without harming other cells on par with existing medicines. "Without patents or comparable incentives to enable that work, we would not have new treatments and cures no matter how many new molecules appear on computer screens," Corey Salsberg, global head of IP affairs at Novartis, said at the hearing.
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Markets
The case for CureVac
CureVac, a pioneer in mRNA, is perhaps best known for a world-historic fumbling of the bag, betting on an approach to the technology its peers had abandoned and then watching from the sidelines as Moderna and BioNTech won global plaudits and billions of dollars for developing Covid-19 vaccines.
The company has lost more than 80% of its value since going public in 2020, but it's still in business, and it still has its mRNA patents, and that's reason enough for a Wall Street reassessment. In a note to investors yesterday, SVB Securities analyst Mani Foroohar pitched CureVac as a battered but unbroken biotech company, one with a potentially lucrative GSK partnership and the prospect of eventually catching up to the mRNA rivals that won the pandemic race.
And even if CureVac never manages to actually develop a medicine of its own, the company's legal strategy could pay handsomely. The German firm has filed patent infringement lawsuits against Pfizer and BioNTech, seeking a royalty on the roughly $80 billion in sales the two have made on their Covid-19 vaccine. As Evercore ISI analyst Jonathan Miller pointed out in a separate note, if CureVac can pry even a modest royalty from its richer competitors, the company would be entitled to a sum greater than its current $2.3 billion valuation.
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