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The necessity-to-know this morning
Rapt Therapeutics stated the FDA positioned a scientific maintain on its anti-inflammation drug, referred to as zelnecirnon, following a case of liver failure in a single affected person enrolled in a mid-stage atopic dermatitis examine. A separate examine in bronchial asthma has additionally been positioned on maintain. Rapt is investigating the reason for the liver failure.
Biotech startups maintain downsizing
The newest is Sonata Therapeutics, born from the merger of two Flagship Pioneering corporations, which has laid off a couple of third of its employees.
As STAT’s Allison DeAngelis reviews, Sonata has parted methods with 21 workers in latest weeks, considerably lowering its prior payroll of 63 individuals. The corporate was created in 2022 by the merger of two Flagship startups, Inzen Therapeutics and Cygnal Therapeutics, and is creating medicines in oncology, fibrosis, and autoimmune issues.
Sonata is amongst a rising variety of privately held biotech startups which have lower employees, curtailed ambitions, and pivoted focus in an effort to preserve money in a tough atmosphere for elevating enterprise capital.
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Bayer, quick on money, reaches into shareholders’ pockets
German pharmaceutical large Bayer is slashing its dividend by 95%, a part of an ongoing effort to preserve money within the wake of its disastrous 2018 merger with Monsanto.
After paying out about $2.50 per share final yr, the corporate’s dividend will quantity to a couple of dime in 2024, Bayer stated yesterday, a lower that can save about $2.5 billion a yr and assist the corporate pay down its debt. The transfer follows information of a deliberate reorganization through which CEO Invoice Anderson, who took the reins final yr, will considerably scale back the agency’s managerial ranks and lay off tons of of workers.
What stays unclear is whether or not Bayer will heed the oft-repeated recommendation of analysts and buyers by splitting its enterprise up, separating its pharmaceutical and shopper well being companies from the crop science division that has been dragging the corporate down.
A most cancers milestone 4 a long time within the making
After a collection of technological roadblocks, scientific setbacks, and regulatory delays, the FDA permitted the primary cell remedy that may deal with strong tumors, a long-awaited milestone in oncology.
As STAT’s Angus Chen reviews, the therapy known as Amtagvi, made by Iovance, and it’s permitted to deal with superior melanoma. Amtagvi is made up of tumor infiltrating lymphocytes, or TILs, that are cancer-fighting immune cells harvested from a affected person’s physique, duplicated in a lab, after which re-infused to kill tumors.
“It is a game-changing second for our discipline,” stated Allison Betof Warner, a cell remedy researcher and doctor at Stanford College who has labored on Amtagvi. “We’ve seen enormous success of mobile remedy for hematologic malignancies, and we’ve but to capitalize on that for strong tumors. That is hopefully the primary of many to return.”
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What occurred to the phage revolution?
Yearly or so, there’s a case report of how a bacteriophage — a virus that infects and kills micro organism — has led to dramatic advantages for a affected person with a life-threatening an infection, stirring hopes that scientists may quickly have a solution for treatment-resistant bugs. However regardless of plain promise and years of labor, profitable phage remedy stays largely a case-by-case phenomenon.
As STAT’s Deborah Balthazar reviews, the largest hurdle is complexity. There are hundreds and hundreds of phages in nature, all behaving in another way and killing particular strains of micro organism. Becoming that recognized universe into a medication cupboard requires cataloging as many phages as attainable, an ongoing however daunting course of.
Then there’s the matter of operating the sort of examine that would result in FDA approval, which requires standardizing phages and particularly recruiting sufferers who’re prone to profit from a given remedy, a difficult course of contemplating all of the variability of bacterial infections.
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Extra reads
A lawsuit over a controversial Sanofi drug scarcity is unexpectedly revived, STAT
After affected person outcry, Taysha begins to dump drug applications, Endpoints
FDA expands use of bronchial asthma drug Xolair to deal with extreme meals allergic reactions, Related Press
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