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A critical area to consider in selecting a CDMO is their ability to successfully complete technology transfers. Recognizing what it takes to complete this process effectively and efficiently is crucial to selecting the best partner for your project and product needs. This white paper delivers an analysis of critical success factors for effective technology transfer.
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Today’s Big NewsDec 15, 2023 |
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Tuesday, December 19, 2023 | 12pm ET / 9am PT Either you want to implement a CLM, or you don’t know how to fix the processes of the one you have in place. Either is a tough place to be in. Join us in this webinar to learn from a CLM solution implementation expert in the highly regulated field of pharmaceuticals. Register now.
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| By Nick Paul Taylor Pfizer just swallowed a $43 billion ADC company and still isn’t full. Hours after Pfizer closed the Seagen buyout, Nona Biosciences put out news that the Big Pharma has committed $53 million in upfront and near-term payments for rights to its mesothelin-targeted ADC, dubbed HBM9033. |
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By Andrea Park Following the publication of a report suggesting that the FDA has a history of taking a lax approach to enforcing regulations around medical device recalls, a pair of senators have requested an investigation into the agency’s actions. |
By Fraiser Kansteiner After contacting the FDA back in July, Republicans in the House Committee on Energy and Commerce are concerned that the agency may have put the kibosh on its unannounced foreign inspection program. In a letter to FDA Commissioner Robert Califf, M.D., they're pressing for answers. |
By Kevin Dunleavy Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely. With a second FDA nod for a much larger patient population, the company can anticipate a more pronounced upswing in revenue from the hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor. |
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Discover the keys to successful Cell & Gene Therapy (CGT) logistics! Our whitepaper delves into intricate trial logistics, emphasizing precision. Learn from specialized expertise, navigate regulatory challenges, and explore real case studies like viral vector-based therapy for Spinal Muscular Atrophy. Ensure patient safety and therapy scalability. Download now to revolutionize CGT treatments!
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By James Waldron With the gold rush in obesity meds showing no sign of abating, Fractyl Health is gearing up to go public as it gathers preclinical evidence that its GLP-1 gene therapy could take on Novo Nordisk’s Wegovy. |
By Fraiser Kansteiner Four dozen Medicare Part B drugs saw their prices grow faster than inflation in the final quarter of 2023, and some drug companies raised prices faster than inflation during every quarter over the last year. The rebates under IRA could save seniors who take the meds between $1 and $2,786 per dose, the White House said. |
By Andrea Park After racking up more than 30 years’ worth of experience in treating chronic pain, spinal cord stimulators have recently begun to expand their remit. |
By Nick Paul Taylor Immusoft has administered an engineered B cell to a human for the first time, marking a milestone in its long-running quest to create a new type of medicine. |
By Helen Floersh A new form of gene therapy designed to treat the most treatment-resistant form of childhood epilepsy appears to reduce seizures in mice. |
By Angus Liu,Kevin Dunleavy,Eric Sagonowsky,Fraiser Kansteiner In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning. |
Fierce podcastsDon’t miss an episode |
| | The Fierce 50 honorees range from tech innovators to researchers developing novel therapies to providers on the frontlines of changing care. This week on "The Top Line," senior editor Paige Minemyer sat down with staff writers Dave Muoio and Anastassia Gliadkovskaya as well as senior editor Heather Landi to discuss a few of the honorees in more detail. |
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Learn how applying a Quality By Design framework in clinical trials saves time, money, and resources by reducing protocol amendments based on past learnings and the design, carrying forward key learnings to benefit future trials, and delivering consistent and efficient delivery of reliable data. Download now.
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| WhitepaperThe road to digital health innovation is exciting but complex and requires thoughtful navigation; this whitepaper serves as your guide through this process. S3 Connected Health |
| WhitepaperqPCR Assay Design - Quantify microbial biomarkers with high sensitivity and dynamic range Sponsored by: Diversigen |
| WhitepaperStreamline your clinical cell therapy with our GMP-compliant ribonucleoprotein (RNP) manufacturing as you scale up without compromising on quality to tackle complex regulatory requirements. Sponsored by: Aldevron |
| WhitepaperIf you find yourself grappling with bioanalytical challenges during the drug development process, rest assured that these obstacles can be overcome - discover more! Sponsored by: Sannova Analytical |
| Whitepaper High performance computing (HPC) combined with artificial intelligence (AI) and machine learning (ML) can speed up research and development processes and dramatically reduce reliance on expensive clinical trials. Download the free solution brief to learn more. Sponsored By: AWS, NVIDIA, and Rescale |
| Executive SummaryBy 2030, the global demand for biologics is projected to grow at a CAGR of 8.7% and the challenges, risks, and costs of bringing large molecule products to market are growing exponentially. Sponsored by: ThermoFisher Scientific |
| WhitepaperLearn about the untapped power of AI-driven insights — where innovation meetings precision, effortlessly unlocking benefits for your organization. Sponsored by: Planisware |
| Whitepaper Medical devices & consumer wearables are starting to overlap, creating risks & opportunities for traditional medical device companies as well as consumer wearables manufacturers. This paper explores pros and cons from both perspectives. Sponsored by: Blue Matter Consulting |
| Whitepaper Improving efficiency and productivity in biologics manufacturing is a longstanding goal within today’s industry, especially now as new and increasingly complex molecules are fundamentally changing technological and operational approaches to drug development. Process intensification can help accelerate this pace of innovation through advanced process development techniques and high productivity manufacturing platforms. Sponsored by: Lonza |
| Whitepaper As a leader of technology transfer activities in the industry, Lonza understands the challenges associated with this critical step. Download this White Paper today to learn more. Sponsored by: Lonza |
| eBookEmulate in vivo biology with next-generation in vitro technology. Sponsored by: Emulate |
| Whitepaper A critical area to consider in selecting a CDMO is their ability to successfully complete technology transfers, which involves an intricate set of activities and disciplines that, if done incorrectly, could result in delays and failures that impact the overall success of your end product. Recognizing what it takes to complete this process effectively and efficiently is crucial to selecting the best partner for your project and product needs. This white paper delivers an analysis of critical success factors for effective technology transfer. Sponsored by: Lonza |
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