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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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Today’s Big NewsJan 17, 2024 |
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This whitepaper explains how Resilience utilizes a Stage-Gate approach to technology transfer and biomanufacturing. Built on proven methods used across industries, the Stage-Gate approach mitigates risk while shortening cycle times throughout the project lifecycle. 
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| By Annalee Armstrong,Gabrielle Masson Biotech executives are reaching into their bag of tricks and coming up with wild ways to access capital. It's not enough to have M&A in mind or plan for an IPO. You need to have both underway, just in case. |
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By Max Bayer Gilead is calling off an expansion of its Oceanside biologics site and plans to move "the majority" of the team to Foster City. A Gilead spokesperson said Kite's viral vector manufacturing facility is not affected by the move. |
By Andrea Park Following a series of reports on the FDA’s alleged history of mishandling medical device recalls, which in turn sparked a request for a government probe of the regulator, the U.S. Government Accountability Office has agreed to take on the job. |
By Annalee Armstrong As green shoots slowly push from the scorched Earth biotech markets, ReCode Therapeutics CEO Shehnaaz Suliman, M.D., is watching closely, biding her time for a potential second half IPO. |
By Zoey Becker After a Texas jury sided with Seagen a patent spat, the U.S. Patent and Trademark Office has invalidated the patent in question. |
By Kevin Dunleavy Three years after bringing Jaguar Gene Therapy out of stealth, Deerfield Management is leading the funding of a manufacturing spinout from the Illinois company. Deerfield, with the help of ARCH Venture Partners and Nolan Capital, is backing a new company—Advanced Medicine Partners—which was formerly responsible for Jaguar’s chemistry, manufacturing and controls (CMC). |
By Nick Paul Taylor Roche has bagged a phase 3 win in TIGIT. But the victory falls short of being a clear-cut endorsement of the mechanism, with the use of a comparator that is no longer the standard of care complicating efforts to tease out the impact of the investigational antibody. |
By Andrea Park Just as users around the world are surely strapping on new Fitbits with an aim of tackling health-focused New Year’s resolutions, so too is Fitbit itself kicking off 2024 with its sights set on a new goal. |
By Fraiser Kansteiner Lonza is axing 218 jobs at its site in Alameda County, California, according to a new Worker Adjustment and Retraining Notification (WARN) alert. The cuts come as Lonza plans hundreds of hires in Switzerland. |
By James Waldron Despite losing a couple of Big Pharma collaborators, Dewpoint Therapeutics is gearing up to finally take its lead biologic condensates into the clinic, clearing out 18 unwanted roles and narrowing its pipeline to make space for the right candidates. |
By Conor Hale Designed for use by primary care providers, the noninvasive optical spectroscopy system is capable of helping to identify the three most common skin cancers at the point of care, including melanoma, basal cell carcinoma and squamous cell carcinoma. |
By Kevin Dunleavy Two cancer therapies have topped Clarivate Analytics’ Drugs to Watch in 2024, an annual report that identifies potential blockbusters and other treatments that could “transform treatment paradigms.” The analysts have pegged Johnson & Johnson’s combination treatment Akeega and Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan to generate $2.7 billion in sales each in 2029. |
By Conor Hale We're looking for the fiercest and most innovative private medtech companies and startups, from around the globe and in every healthcare area, for our annual list of the Fierce 15. |
Fierce podcasts Don’t miss an episode |
| This week on "The Top Line," Fierce Biotech staff writer Gabrielle Masson and senior editor Annalee Armstrong look back at the year in biotech, which was defined by massive layoffs across the industry. They also discuss their favorite stories of the year, including an appearance from a popstar whose reputation precedes her. |
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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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