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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 13, 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 Zoey Becker The Supreme Court's final decision could have consequences beyond abortion access. That's because the original verdict questioned the FDA's decision-making authority, prompting amicus brief submissions from high-profile industry players. |
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By Gabrielle Masson After receiving the FDA greenlight for its sickle cell disease (SCD) gene therapy, Vertex Pharmaceuticals is paying $100 million for rights to Editas Medicines’ Cas9 gene-editing tech, a deal that encompasses freshly approved Casgevy amid a long-running patent battle. |
By Conor Hale Integra LifeSciences hopes to provide hardware for a range of procedures aimed at the neck and up, pairing ENT with neurosurgery. |
By Kevin Dunleavy Using Tuesday to announce good news—that its $43 billion acquisition of Seagen would be finalized on Thursday—Pfizer sandwiched its bad news, which came on Wednesday with its 2024 guidance. The company expects revenue to reach between $58.5 billion and $61.5 billion next year, coming up short of the analyst consensus of $63.2 billion, largely because of the plummeting demand for its COVID-19 products. |
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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 Max Bayer MAPS PBC has filed the first new drug application for a psychedelic-assisted therapy, asking regulators to greenlight MDMA use in patients with PTSD. |
By Andrea Park SomaLogic’s plan to combine with Standard BioTools in a merger valued at more than $1 billion has hit a speed bump. |
By Fraiser Kansteiner After wrapping up a $200 million renovation at a former Boehringer Ingelheim plant near Cleveland, Ohio, several years back, Danish specialty drugmaker Xellia Pharmaceuticals is paring back its workforce in The Forest City. |
By Nick Paul Taylor Vertex’s decision to double down on a pain program has delivered a phase 2 win. The biotech linked its NaV1.8 inhibitor VX-548 to statistically significant improvements in pain intensity in people with painful diabetic peripheral neuropathy (DPN), encouraging it to start planning a pivotal program. |
By Andrea Park Users of Tandem Diabetes Care’s insulin pumps now have a new way to monitor the pumps’ data and manage their equipment. |
By Zoey Becker The state-of-the art manufacturing center will be split into three buildings at the current location of Sandoz' Lek subsidiary in Lendava and should be operational by 2026. |
By James Waldron Venture capital firm Sofinnova Partners has launched a new investment strategy specifically aimed at setting up and accelerating biotech startups across Europe. |
By Conor Hale Launched from the medtech incubator Shifamed, Laza is starting off with a $36 million series A backed by The Capital Partnership, GE HealthCare, PA MedTech VC Fund, Unorthodox Ventures and Dara Holdings. |
Fierce podcastsDon’t miss an episode |
| | Amphotericin B, an effective antifungal with rare resistance, is associated with significant kidney damage, prompting the search for a potential alternative. This week on "The Top Line," Fierce Biotech Research’s Helen Floersh spoke with Martin Burke, M.D., Ph.D., founder of antifungal startup Sfunga Therapeutics, to discuss the design and path to clinic of a promising new drug that could shape the future of antimicrobials. |
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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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