Articles

  • 1 week ago | biospace.com | Dan Samorodnitsky

    Cambridge, Massachusetts–based Vor Bio is bowing out amid a tough funding environment after examining the clinical data currently available for its assets. The company, co-founded in 2015 by oncologist and Pulitzer Prize-winning author Siddhartha Mukherjee based on work from his Columbia University laboratory, was focused on cell therapies for acute myeloid leukemia and myelodysplastic syndrome.

  • 1 week ago | biospace.com | Dan Samorodnitsky

    Vinay Prasad is an oncologist and hematologist at the University of California, San Francisco, as well as a frequent health policy critic on his YouTube channel and various podcasts. Now, he can add chief of the FDA’s Center for Biologics Evaluation and Research to his resume, becoming just the third person to lead the relatively new division, which reviews biological drugs, including cell and gene therapies and vaccines.

  • 1 week ago | biospace.com | Heather McKenzie |Jef Akst |Annalee Armstrong |Dan Samorodnitsky

    > Listen on Spotify> Listen on Apple Products> Listen on Amazon Music> Listen on iHeartIn his effort to onshore manufacturing, President Donald Trump issued an executive order on Monday afternoon ordering the FDA to ease permitting processes for new and expanded U.S. facilities. The announcement comes as more and more Big Pharma companies commit billions to expanding their U.S. footprints.

  • 1 week ago | biospace.com | Dan Samorodnitsky

    PTC Therapeutics announced new data Monday from a Phase II trial showing that Huntington’s hopeful PTC518 could modify a key disease indicator of the disease. The data received mixed reviews, however, and shares of the biotech nose-dived. In a Monday afternoon note to investors, William Blair analysts said that a “question regarding correlation between [huntingtin] reductions and clinical benefit remains,” but added that the 24-month data should aid FDA dialogue.

  • 2 weeks ago | biospace.com | Annalee Armstrong |Dan Samorodnitsky

    Moderna’s sales continued to tumble in the first quarter, falling to $84 million compared to analyst expectations of $100 million. But the mRNA biotech managed to beat on earnings per share (EPS) thanks to aggressive cost cutting measures that lowered operating expenses. In that vein, the company on Thursday announced plans to cut another $1.5 billion by 2027, adding to billions in cuts that are already planned.

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