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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 6, 2023 |
| By Kevin Dunleavy Novartis has gained the first of what it hopes are several FDA approvals for its factor B inhibitor iptacopan, dubbed two months ago “a pipeline in pill,” by analysts at ODDO BHF. The U.S. regulator has given a thumbs up to iptacopan to treat paroxysmal nocturnal hemoglobinuria (PNH). Known commercially as Fabhalta, it becomes the first oral monotherapy approved by the FDA for the rare blood disorder, which affects 10 to 20 people per one million worldwide. |
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By Nick Paul Taylor Merck KGaA just sent shockwaves through the BTK inhibitor space. Evobrutinib, the German drugmaker’s contender for a blockbuster opportunity, failed to beat Sanofi’s Aubagio in two phase 3 multiple sclerosis (MS) clinical trials, raising doubts about the prospects of a clutch of heavily backed rival candidates. |
By Conor Hale Dexcom’s G7 CGM will now be able to feed its real-time blood sugar readings to Tandem’s t:slim X2 pump as part of an artificial pancreas system, enabling automated insulin delivery and dosing calculations. |
By Annalee Armstrong Patients taking Pharvaris’ preventative oral medicine for hereditary angioedema experienced an 84.5% reduction in monthly attacks during a phase 2 study. The results represent a comeback for the medicine, which was placed on a clinical hold by the FDA last year. |
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Thursday, December 13, 2023 | 11am ET / 8am PT In this webinar discover how CDMOs drive efficiency, ensure quality, and enable scalability in biologics production and stay ahead in the dynamic world of biologics with a focus on the transformative CDMO impact. Reigster now. 
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By Angus Liu Novartis’ Kisqali is getting a leg up in the CDK4/6 breast cancer realm as another rival failed to significantly extend patients’ lives in a pivotal trial. |
By Angus Liu Seagen unveiled detailed data showing its Tukysa could offer additional tumor progression benefit on top of Roche’s ADC Kadcyla. But with a negative early trend in overall survival, Seagen seems not ready to knock on the FDA’s door. |
By Max Bayer As a flurry of recent developments underscores the coming wave of new psychiatric treatments, one biotech is looking to carve out relevance in the PTSD space, pointing to new phase 2 data as evidence. |
By Conor Hale The CE mark covers the company’s Percept RC neurostimulator for patients with Parkinson’s disease, essential tremor, primary dystonia and epilepsy. |
By Zoey Becker In 2017, Daiichi's former subsidiary Plexxikon alleged that Novartis stepped on its Zelboraf patents with its GSK-acquired medicine Tafinlar. Many years later, Novartis is settling the case. |
Fierce podcasts Don’t miss an episode |
| In this episode of "The Top Line," we're highlighting the remarkable women featured in our annual Fiercest Women in Life Sciences special report. The list comprises 10 trailblazers changing the leadership landscape in pharma, biotech and medtech. |
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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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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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