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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 19, 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 Nick Paul Taylor Novo Holdings is fattening up as patients slim down. Boosted by the Wegovy windfall, the fund manager's CEO Kasim Kutay expects to do “a fair amount” more deals in 2024 and to open a second office in Asia. |
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By Conor Hale “CMS does not have the expertise to assure that tests work; the FDA does,” wrote leaders from both federal agencies. |
By Kevin Dunleavy Use of Amgen’s osteoporosis drug Prolia by those with advanced chronic kidney disease (CKD) can increase the risk of calcium loss in the blood, according to the FDA. The U.S. regulator has added a boxed warning for the blockbuster treatment, which has been on the market for 14 years and loses patent protection next year. |
By Max Bayer,Gabrielle Masson BioMarin's new CEO Alexander Hardy is wasting no time overhauling the company, sending Chief Commercial Officer Jeffrey Ajer for the exits. |
By Zoey Becker The Senate Committee on Health, Education, Labor, and Pensions will vote on issuing subpoenas at the end of the month after the Johnson & Johnson and Merck CEOs refused to testify at an upcoming hearing. |
By Andrea Park Spinal cord stimulation has been available as a chronic pain treatment for decades, but even now, Medtronic—which was the first to make the implants commercially available in the late 1960s—is still improving on the technology. |
By Angus Liu Novartis hopes new data will open a $1 billion market opportunity for its radioligand therapy, Lutathera, as a first-line treatment. Friday, the company's ambition received a boost from the phase 3 readout of the NETTER-2 trial. |
By Gabrielle Masson,Max Bayer We really didn't want to have to create another Layoff Tracker this year. But here we are, launching the third annual iteration tracking biopharma layoffs. |
By Kevin Dunleavy A federal jury has found a former Pfizer statistician guilty of insider trading after a two-week trial in Manhattan. The jury convicted Amit Dagar, 44, of Hillsborough, N.J., of using advance information on successful trial results for Pfizer’s COVID-19 treatment Paxlovid to make more than $270,000 in stock trades. |
By Max Bayer Kyverna has nabbed FDA fast track designation for its lead asset to treat multiple sclerosis, adding momentum to its IPO roadshow days after declaring plans to go public. |
By Andrea Park Dexcom has joined the scrum of major U.S.-based medtech companies flocking to Ireland as a European home base. |
By Angus Liu With the metastatic liver cancer field getting increasingly crowded for immunotherapies, AstraZeneca is trying to reach new ground with Imfinzi in locoregional disease. But a regulatory hurdle lies ahead. |
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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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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