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Stability and particle formation are key variables across the lifecycle. New instruments that improve measurement are transforming testing and becoming necessary. Download this essential reading now for biopharma companies that want to understand how particle detection is evolving and the value new technologies provide across the lifecycle. 
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Today’s Big NewsJan 22, 2024 |
| By James Waldron Ionis Pharmaceuticals’ investigational treatment for hereditary angioedema (HAE) has hit the primary endpoint of a phase 3 trial, allowing the biotech to ready its approval application to the FDA. |
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By Nick Paul Taylor Genentech is walking away from an 18-year relationship with AC Immune, handing back global rights to a pair of Alzheimer’s disease drug candidates after suffering a series of setbacks in the clinic. |
By Annalee Armstrong Fierce Biotech recounts the top 10 clinical trial failures of 2023 that sent ripples across the industry. |
Sponsored by Cardinal Health Cell and gene therapy patients often require support throughout their treatment journey. Learn key considerations for developing patient support programs. |
By Nick Paul Taylor Sagimet Biosciences has eased the pain of investors who backed its IPO last year, reporting phase 2b data in metabolic-associated steatohepatitis that sent its stock soaring. Yet, the 20% dropout rate in the drug arm and exclusion of patients from the analysis prompted questions from analysts. |
By James Waldron Pharvaris’ preventative oral medicine for hereditary angioedema (HAE) has had its remaining clinical hold lifted by the FDA weeks after the treatment proved its worth in a phase 2 study. |
By Max Bayer Cara Therapeutics is laying off up to 50% of its team as the company narrows its clinical ambitions. An oral version of FDA-approved Korsuva has failed to distinguish itself in studies. |
By Gabrielle Masson Arrivent Biopharma has said it will raise around $135 million in the company’s upcoming public offering. |
By Helen Floersh A drug used to treat irritable bowel syndrome appears to be effective against prostate cancer in mice when given in tandem with chemotherapy, a new study shows. |
By Zoey Becker The antibody-drug conjugate did not significantly improve survival outcomes compared with a chemotherapy alone in previously treated patients with metastatic non-small cell lung cancer. The trial outcome marks a setback in Gilead's ambition to grow its presence in the oncology sector. |
By Andrea Park Just a few weeks after earning a permanent injunction barring the use of Invitae’s Personalized Cancer Monitoring tests, Natera is taking another of the diagnostic developer’s product portfolios off its hands. |
By Angus Liu More than five years after an FDA accelerated approval in a subtype of progressive colorectal cancer, Bristol Myers Squibb now has data supporting its checkpoint inhibitor doublet in newly diagnosed patients. But another approval may have to wait. |
By Conor Hale The Osteoboost belt, developed by Bone Health Technologies, is a far cry from the century-old mechanical devices that once claimed to promote weight loss and overall vigor. |
By Heather Landi The health insurance giant, which serves 117 million people, sees opportunities to leverage generative AI and other technologies to make healthcare easier to navigate, chief AI officer Shawn Wang said during an interview at CES 2024. |
Fierce podcasts Don’t miss an episode |
| At Fierce Pharma, the arrival of a new year is synonymous with the release of our annual special report on drug approvals. This week on “The Top Line,” Fierce Pharma’s Eric Sagonowsky and Kevin Dunleavy, both instrumental in creating the special report, are breaking down the numbers and sharing key insights into the landscape of drug approvals in 2023. |
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This whitepaper reveals how to strategically scale processes, offering developers flexibility from 1,000L to an industry-leading 5,000L in a single-use bioreactor. Meticulous optimization ensures high-quality drug products, while expert-led parameter fine-tuning guarantees consistent growth across scales. Explore how suspension cells lead the way, providing a robust and adaptable manufacturing platform for gene therapy breakthroughs. .png)
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Whitepaper The road to digital health innovation is exciting but complex and requires thoughtful navigation; this whitepaper serves as your guide through this process. Sponsored by: S3 Connected Health |
Whitepaper Discover how to effectively classify highly potent APIs and the steps required to develop containment protocols and manufacturing processes that are both safe and efficient. Sponsored by: Catalent |
eBook This e-book explores 7 factors that are critical to the success of emerging biopharma companies, whether they plan to out-license, partner, or launch & commercialize products. It’s an essential resource for emerging companies with products in all stages of development.
Presented by Blue Matter, strategic consultants in the life sciences |
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