| Editor’s Note: Fierce Biotech will be taking a break for the Labor Day holiday. We will be back in your inbox on Tuesday, Sept. 5 |
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September 26, 2023 | 1:00 PM ET Planning to commercialize a gene therapy product? Learn how you can maximize revenue potential and navigate the market’s unique challenges with Trinity Life Sciences. Ready to tackle the elephant? Register Now.
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Today’s Big NewsSep 1, 2023 |
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Understand how to navigate EU regulations to launch rare disease medicines in European markets. Download guide.
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Thank you to Bridge Bankfor sponsoring our editorial feature: Fierce 15 |
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| By James Waldron Sana Biotechnology isn't revealing how many employees have been affected by its latest round of layoffs, only confirming that the CAR-T-focused company has sought further “operational efficiencies.” |
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By Nick Paul Taylor NexImmune is handing out pink slips again. Running close to the end of its cash runway, the immunotherapy biotech is halving its head count to support investment in its nanoparticle platform. |
By Max Bayer Japanese pharma Otsuka is acquiring Mindset Pharma for $59 million, adding a suite of preclinical psychedelics. The larger company is looking to build on its portfolio of Lundbeck-partnered antipsychotics that each raked in hundreds of millions of dollars last quarter. |
Sponsored by Novartis Global Biotech Cooperations With the rapid increase in cell and gene manufacturing, companies need support from experienced, reliable, and global, CDMO's with a deep and rich technology network. |
By Nick Paul Taylor Bavarian Nordic’s vision of ending the COVID-19 vaccine adaptation cycle is over. The Danish drugmaker found its phase 3 trial data support the need for variant-specific vaccines and, because its shot cannot be adapted quickly, has accepted the candidate “no longer represents a commercial opportunity.” |
Sponsored by IPM.ai Using artificial intelligence to predict and uncover de-identified rare disease patients shortens the time to diagnosis, benefiting both patients and life science companies. |
By Max Bayer,Gabrielle Masson Some six months after Sanofi's former R&D chief John Reed announced his jump to Johnson & Johnson, the pharma has found his replacement, naming Houman Ashrafian for the job. |
By Annalee Armstrong,Max Bayer,Gabrielle Masson Fierce Biotech's M&A Tracker, your one-stop shop for dealmaking in the biopharma universe. |
By Helen Floersh A team co-led by Carl June, M.D., has created CAR-Ts that target the antigen CD45, a protein found on the surface of nearly all blood cells. They knocked out leukemia cells in mice in just three weeks. |
By Fraiser Kansteiner Friday, the U.S. Federal Trade Commission (FTC) said it reached a proposed consent order with Amgen to address “the potential competitive harm” that could result from the merger deal. Now, Amgen is free to go forward with its $28 billion buyout. |
By Andrea Park In a flurry of Aug. 31 notices from the FDA, the number of Class I recalls plaguing Getinge’s Cardiosave intra-aortic balloon pumps this year has doubled. |
By Noah Tong Organizations signed a letter pledging support for a CMS-backed transitional coverage for emergency technologies pathway, which they say could improve patient care, prevent hospitalizations and reduce costs. |
By Kevin Dunleavy It was a year ago this month that President Joe Biden signed the Inflation Reduction Act. While the landmark bill introduces several pricing measures, Democrats on Capitol Hill are still pursuing ways to rein in the pharma industry. They are pressing insulin manufacturers on their plans to cut prices. They also are asking the FDA to adjust its management of the patent system to bolster competition. |
By Angus Liu Generics to Takeda's blockbuster ADHD drug Vyvanse are now approved in the U.S. Merck and Eisai's Keytruda-Lenvima combo failed in another pivotal trial. ADC Therapeutics walked away from an antibody-drug conjugate partnership with Adagene. Plus more. |
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