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The necessity-to-know this morning
- Rapt Therapeutics mentioned the FDA placed a clinical hold on its anti-inflammation drug, known as zelnecirnon, following a case of liver failure in a single affected person enrolled in a mid-stage atopic dermatitis research. A separate research in bronchial asthma has additionally been positioned on maintain. Rapt is investigating the reason for the liver failure.
Biotech startups preserve downsizing
The most recent is Sonata Therapeutics, born from the merger of two Flagship Pioneering firms, which has laid off a couple of third of its workers.
As STAT’s Allison DeAngelis stories, Sonata has parted methods with 21 staff in latest weeks, considerably lowering its prior payroll of 63 folks. The corporate was created in 2022 by way of the merger of two Flagship startups, Inzen Therapeutics and Cygnal Therapeutics, and is growing medicines in oncology, fibrosis, and autoimmune problems.
Sonata is amongst a rising variety of privately held biotech startups which have lower workers, curtailed ambitions, and pivoted focus in an effort to preserve money in a tough setting 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 12 months, the corporate’s dividend will quantity to a couple of dime in 2024, Bayer said yesterday, a lower that may save about $2.5 billion a 12 months and assist the corporate pay down its debt. The transfer follows information of a planned reorganization through which CEO Invoice Anderson, who took the reins final 12 months, will considerably scale back the agency’s managerial ranks and lay off a whole lot of staff.
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 client well being companies from the crop science division that has been dragging the corporate down.
A most cancers milestone 4 many years within the making
After a collection of technological roadblocks, medical 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 stories, the remedy is named 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.
“This can be a game-changing second for our subject,” mentioned Allison Betof Warner, a cell remedy researcher and doctor at Stanford College who has labored on Amtagvi. “We’ve seen large 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 come back.”
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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 simple promise and years of labor, profitable phage remedy stays largely a case-by-case phenomenon.
As STAT’s Deborah Balthazar stories, 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 form of research that might 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, Associated Press
