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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 14, 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 Max Bayer Changes are afoot atop Amgen's leadership team, with the company hiring Jay Bradner as chief scientific officer and R&D leader. Previous R&D head David Reese is now the chief technology officer. |
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By Kevin Dunleavy It’s a done deal. Pfizer’s $43 billion acquisition of Seagen is in the books, as it becomes the largest M&A transaction in the biopharma industry since AbbVie snatched up Allergan for $63 billion in 2019. The buyout of the antibody-drug conjugate specialist has doubled Pfizer’s pipeline to 60 programs. |
By Conor Hale Pulsed field ablation aims to treat atrial fibrillation, the common irregular heartbeat that carries an elevated risk of stroke, without excess heat or tissue damage compared to today's standard radiofrequency catheters. |
By James Waldron After a year when most biotechs had given up on going public in the near term, the IPO window will “gradually reopen” next year—at least that’s what analysts at PwC are betting on. |
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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 Andrea Park Google unveiled MedLM in a blog post Wednesday, noting that its first two models are now available to U.S. Google Cloud customers via the company’s Vertex AI platform, which uses machine learning workflows to guide users through the process of training, evaluating and deploying generative AI models. |
By Angus Liu Despite the high list price of Lyfgenia, bluebird has signed a large reimbursement deal for the sickle cell disease gene therapy less than a week after its FDA approval. |
By Gabrielle Masson Reneo Pharmaceuticals’ rare genetic disease study has missed both primary and secondary goals, prompting the California biotech to halt the development of its only asset and lay off 70% of staff. |
By Fraiser Kansteiner Four dozen Medicare Part B drugs saw their prices grow faster than inflation in the final quarter of 2022, and some drug companies raised prices faster than inflation during every quarter last year. The proposed rebates under IRA could save seniors who take the meds between $1 and $2,786 per dose, the White House said. |
By Nick Paul Taylor Vir Biotechnology has delivered unseasonably gloomy news to its employees, outlining plans to eliminate 75 positions and shutter two U.S. facilities to save more than $40 million a year. |
By Andrea Park On the heels of new research affirming its technology’s ability to help treat and even reverse the progression of Type 2 diabetes, Twin Health has raked in another round of funding to support the spread of the tech. |
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 |
Whitepaper Streamline 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 |
Whitepaper If 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 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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