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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 12, 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 Fraiser Kansteiner With the initial shock of AbbVie and Johnson & Johnson's disease-specific approval pull for Imbruvica now fading into the rearview, the partners are making the case for the BTK inhibitor to stage a comeback in mantle cell lymphoma. |
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By Nick Paul Taylor Bristol Myers Squibb has filled the antibody-drug conjugate-shaped hole in its pipeline by following the increasingly well-trodden path to China, handing SystImmune $800 million upfront for a phase 1/2 solid tumor candidate as part of a deal worth up to $8.4 billion. |
By Andrea Park In the study, patients with Alzheimer’s were tasked with using Cognito’s neuromodulation headset for an hour each day for the entire six-month study period. |
By Zoey Becker The drugmaker will lay off 79 at its New Jersey headquarters and 55 at its microbiome subsidiary Rebiotix in Minnesota as a result of a "revised business strategy." |
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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 Gabrielle Masson The FDA is creating a new advisory committee made up of nine voting members who will provide insight on potential treatments for genetic metabolic diseases. |
By Andrea Park Less than a year after ZimVie tapped Brainlab to add its surgical guidance technology to ZimVie’s own spinal surgery devices, the partnership has already paid off. |
By Angus Liu Another data face-off between the two anti-CD38 multiple myeloma drugs—J&J's Darzalex and Sanofi's Sarclisa—took place at the ASH conference. Both regimens showed strong efficacy in newly diagnosed patients, but only one result is considered practice-changing right now. |
By Nick Paul Taylor The Federal Trade Commission has scuttled Sanofi’s licensing deal with Maze Therapeutics. With the FTC moving to block the deal, the Big Pharma is pulling out rather than working through the antitrust maze that has sprung up between it and the asset. |
By Kevin Dunleavy By agreeing to donate royalties on its U.S. sales of bladder cancer drug Bavencio, Pfizer has received the go-ahead to finalize its $43 billion buyout of Seagen, the company said on Tuesday. Pfizer expects to close the merger on Thursday. The company also announced a restructuring of its organization, with leadership changes. |
By Max Bayer If you can raise more in a tough financing environment, then why not? Such was the calculus for Bicara Therapeutics, which raised its second nine-digit financing in 2023 after building momentum off new data. |
By Fraiser Kansteiner Resilience is expanding operations at the West Chester, Ohio, facility it bought from AstraZeneca in January, the technology-focused contract manufacturer said Monday. In turn, the company expects to create some 440 new jobs with an associated annual payroll of nearly $29 million over the next three years. |
Fierce podcasts Don’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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Whitepaper The 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 |
Whitepaper qPCR Assay Design - Quantify microbial biomarkers with high sensitivity and dynamic range Sponsored by: Diversigen |
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Executive Summary By 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 |
Whitepaper Learn 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 |
eBook Emulate 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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