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Join industry leaders at HLTH 2023 on October 8-11 in Las Vegas - featuring the NEW Pharma & Life Sciences Insights Program – for a deep dive into the world of digital technologies. Register here! 
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Today’s Big NewsAug 14, 2023 |
| By Angus Liu Another off-the-shelf, BCMA-directed drug has arrived for the treatment of multiple myeloma. Pfizer's new Elrexfio will challenge Johnson & Johnson's entrenched position in the market. |
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| Philadelphia, PA |  |
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By James Waldron The FDA has put an early-phase trial of 2seventy bio’s CD33-targeted CAR-T cell therapy on hold in the wake of a patient death. |
By Andrea Park Though rebuked by shareholders in a vote earlier this year that kept its executives potentially liable for any legal issues related to its recent recall-related troubles, Philips has gotten a major confidence boost from a new investor. |
By Fraiser Kansteiner As layoffs continue to roil the biotech industry, bigger drugmakers and manufacturers like Bristol Myers Squibb and Emergent BioSolutions haven’t been immune. Now, Thermo Fisher Scientific is among the latest to plot hundreds of job cuts. |
By Gabrielle Masson Gracell Biotechnologies is shaving down its CAR-T pipeline, throwing several programs out the window in an effort to speed its most advanced programs to the finish line. |
By Andrea Park Between last summer and the start of this year, Medtronic racked up two Class I tags from the FDA for a pair of recalls that first concerned 1 million hemodialysis catheters and then another 359,000, all of which were found to be at risk of internal leaking and cross-contamination. Now, the dialysis catheters are in the FDA’s crosshairs once again for an entirely new issue. |
By Kevin Dunleavy Following FDA approvals for fellow PAPR inhibitors made by AstraZeneca/Merck and Pfizer, Johnson & Johnson has got its own combo approval in prostate cancer. The tablet treatment, known commercially as Akeega, combines J&J’s Zytiga and niraparib. |
By Fraiser Kansteiner Daxxify snagged its first therapeutic indication with Monday's FDA nod to treat cervical dystonia in adults. The green light comes a little less than a year after the Revance injection’s initial approval for temporary improvement of glabellar lines, or frown lines. |
By Conor Hale The FDA is urging the public to throw away any pregnancy or ovulation tests manufactured by Universal Meditech, Inc.—a final step to remove the troubled company’s products from the market following previous diagnostic recalls and the shutdown of its California production facilities after they were found to be operating without permits. |
By Nick Paul Taylor BioXcel Therapeutics is cutting deep to cope with the collapse of its cash runway. With BioXcel unlikely to meet the requirements for an anticipated cash infusion, the biotech is laying off almost 60% of its staff and narrowing its focus to keep going through the middle of next year. |
By Joseph Keenan GeneFab, a newly formed contract research, development and manufacturing organization focused on cell and gene therapies, inked a deal to sublease Senti Biosciences’ production facility and pay up to $38 million for the biotech's manufacturing equipment. |
Fierce podcasts Don’t miss an episode |
| This week on "The Top Line," we discuss left-handedness and its significance in neurodevelopmental and psychiatric disorder research. |
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From the team behind Fierce Pharma, Fierce Biotech, and Fierce Healthcare, Fierce Life Sciences Events. Explore our up-coming events this Fall, there's something for everyone! Secure your spot and save today! 
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Webinar Download this webinar to learn how to avoid pitfalls when characterizing CAR-T cells in your development workflow, how to save time by using one antibody to examine your entire panel of CARs, and more. Sponsored by: Cell Signaling Technology |
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