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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 16, 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 Gabrielle Masson,Annalee Armstrong,Max Bayer As the biotech industry attempts to claw its way out of a brutal bear market, investors are starting to pull their punches in preference for more sure bets. |
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By Angus Liu Since the FDA approved the first CAR-T therapy back in August 2017, high prices, small patients pools and limited manufacturing capacity have at times crippled these cell-based treatments. As biopharma companies clear those hurdles, a larger, more systemic problem now threatens the drug class. |
By Kevin Dunleavy Vertex Pharmaceuticals and CRISPR Therapeutics have scored an FDA approval for their gene-editing therapy Casgevy (exa-cel) to treat transfusion-dependent beta thalassemia (TDT). The approval came more than two months ahead of the FDA's March 30 decision date. |
By Angus Liu After crowning Keytruda as the first immunotherapy for advanced cervical cancer back in 2021, the FDA has awarded the drug another industry-first designation in an earlier stage of the tumor type. But again, the achievement was not perfect for Merck. |
By Andrea Park The import ban affects only domestic sales of the Series 9 and Ultra 2 models of the Apple Watch, which Apple briefly stopped selling in the U.S. for a few days in December before the import ban took effect. |
By Nick Paul Taylor Allakos is giving up on lirentelimab after the serial flop racked up another pair of failures. The biotech responded by laying off half of its employees, continuing the early-year upheaval that has seen Aclaris and TransCode Therapeutics part ways with their CEOs. |
By Conor Hale The AI developer Imvaria has claimed a de novo clearance from the FDA for a digital diagnostic that analyzes chest CT scans for the signs of IPF. |
By Kevin Dunleavy It was a decade and four companies ago that HyQvia was first approved by the FDA for primary immunodeficiency (PI). Ten years later, Takeda’s subcutaneous immune globulin treatment has scored its second indication, as the FDA has approved it as a maintenance therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). |
By James Waldron As Alto Neuroscience’s machine learning-derived, biomarker-based depression therapies accrue positive phase 2 data, the company is planning to join the growing trickle of biotechs planning to IPO in early 2024. |
By Andrea Park For the third time since 2022, when it purchased infusion pump maker Ivenix for $240 million, Fresenius Kabi has earned a Class I rating from the FDA for a recall of the Ivenix medication delivery technology. |
By Fraiser Kansteiner As other British drugmakers like AstraZeneca look abroad to build new factories, GSK is sticking close to home, where it plans to plug hundreds of millions of pounds into the United Kingdom over the next two years. |
By James Waldron Genevant Sciences could be in line for up to $114.3 million as part of a deal to combine its lipid nanoparticle tech with Tome Biosciences’ programmable genomic integration expertise to develop an in vivo gene editing treatment for a rare liver disorder. |
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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