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Telix abruptly pulled the plug on its initial public offering plans to begin trading Friday on the Nasdaq, saying the company “did not feel that the proposed discounts were aligned with its duty to its existing shareholders.”
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Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner.
Early decisions about manufacturing and supply chains could prove costly as a company reaches the commercial stage.
While the TrumpRx deals only cover Lilly and Novo for now, the agreements are good for any cardiometabolic biotechs waiting in the wings, according to a new 2026 preview report from PitchBook.
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Bayer announced today late-breaking data from prespecified exploratory subgroup analyses of FIDELITY, a prespecified pooled analysis of the Phase III FIDELIO-DKD and FIGARO-DKD trials.
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Read our takes on the biggest stories happening in the industry.
After covering the Alzheimer’s space through every high and low, BioSpace’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance.
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More than 54% of patients treated with mirikizumab achieved clinical remission at 52 weeks versus 19.6% of those on placebo. Eli Lilly will submit a marketing application in Crohn’s disease to the FDA in 2024.
The regulator issued a Complete Response Letter citing “deficiencies” at the company’s Reykjavik plant, this time for its Stelara biosimilar AVT04. It’s the fourth FDA rejection for Alvotech since last year.
In a Phase Ib/II study, Tempest Therapeutics’ investigational PPAR⍺ antagonist—combined with Roche’s Avastin and Tecentriq—showed strong signs of survival benefits in liver cancer patients.
The layoffs, set to take effect in late November, will impact about a third of Reata’s headcount. The workforce reduction comes just weeks after Biogen completed its $7.3 billion Reata buy.
An increase in funding share and available lab space helps to keep the Bay State’s biotech and pharma sectors strong.
The MeiraGTx founder and CEO, now on her third career, didn’t take a typical path.
The subcutaneous version of its blockbuster multiple sclerosis drug notched a victory in a key late-stage study. Roche will submit the OCARINA II data to global health authorities in the coming months.
The next frontier in RNA therapies, RNA editing has the potential to treat both genetic and common disorders, and the technology is rapidly expanding beyond the liver.
The biotech is laying off about 29% of its employees and will focus its resources on the company’s hypoimmune platform. The latest downsizing follows a previous round of layoffs in August 2023.
The European Commission on Thursday ordered Illumina to divest Grail, opening the next chapter in the years-long regulatory saga. Illumina is reviewing the order, Reuters reported.