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Efficiency & productivity in biologics manufacturing is a longstanding goal, as increasingly complex molecules transform approaches to drug development. Process intensification, with advanced techniques & high productivity platforms, accelerates this pace of innovation. Read white paper. .png)
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Today's Big NewsJul 24, 2023 |
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Thursday, August 3, 2023 | 11am ET / 8am PT Join us for this insightful discussion on how to unlock the full potential of liquid biopsy and be an integral part of the future of precision medicine. We’ll take a deep dive into the latest strategies and solutions designed to help overcome current challenges and empower researchers and clinicians with enhanced capabilities. Register now. 
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| By Fraiser Kansteiner Pfizer on Friday said it kicked off “immediate efforts” to provide relief and repair to the damage caused to its manufacturing facility in Rocky Mount, North Carolina. It noted crews are working around the clock to restore power, assess the structural integrity of the building and to relocate finished medicines to nearby sites for storage. |
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| Philadelphia, PA |  |
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By James Waldron Gilead’s $4.9 billion bet on Forty Seven has run into further trouble, with the Big Pharma pulling the plug on its myelodysplastic syndromes (MDS) ambitions for the lead CD47 asset from that deal in the face of a disappointing phase 3 trial. |
By Andrea Park It’s been a long, uphill battle, but Philips may finally be regaining its financial footing. |
By Max Bayer Roche is betting more than $300 million in immediate cash that Alnylam's phase 2-stage hypertension med is a winner. Roche will have exclusive ex-US rights to the drug and both companies will co-commercialize and share profits inside the US. |
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Wednesday, September 6, 2023 | 2:00 PM ET / 11:00 AM PT Attendees will learn about tools for interacting with medical images, guiding readers through labeling workflows, and streamlining adjudication and data standardization. Real-world use cases of how pharma companies are enhancing AI development by optimizing reader workflows will be discussed. Register now. 
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By Fraiser Kansteiner Leveraging a stock exchange offer—also known as a split-off—J&J aims to reduce its stake in Kenvue by roughly 80%, the company said Monday. Under the exchange offer, which is expected to be tax-free, J&J shareholders may exchange all, some or none of their common stock for Kenvue shares, J&J said. |
By Andrea Park Since early 2020, BD’s Alaris infusion pump systems have received more than half-a-dozen Class I hardware and software recalls, a handful of cybersecurity warnings and a years-long distribution hold. But with a newly bestowed FDA clearance, the company hopes to get the system back on track. |
By Zoey Becker After Teva and Alvotech's proposed Humira biosimilar suffered a second FDA rejection because of issues at Alvotech's manufacturing plant, Teva is pledging increased involvement at the plant. The pair will also add two more biosimilar prospects to their deal. |
By Max Bayer Amgen's difficult streak of lupus candidates persisted after Horizon's mid-stage asset failed a phase 2 trial. The newly-acquired company is continuing to study daxdilimab in other forms of the condition as well as alopecia. |
By Fraiser Kansteiner In a warning letter published late last week, the FDA chided Centaur for production shortfalls found during a November 2022 inspection of the company’s Maharashtra, India, drug ingredients plant. The rebuke centered on just two observations about quality deficiencies and lapses in cleaning protocols. The latter problem carried the risk of API contamination, the FDA said. |
By Conor Hale The motorized ES system helps stabilize the surgeon’s direct manual control of their instrument, with the goal of reducing natural hand tremors. |
By Kevin Dunleavy SK Chemicals of Korea has signed a deal with AstraZeneca to manufacture type 2 diabetes drug Sidapvia through the rest of the decade, according to a regulatory filing. Sidapvia was approved in Korea last month. |
By Max Bayer Heron Therapeutics is going through its second round of layoffs in 13 months, resulting in a 25% reduction of the team. The company is right-sizing its expenses due to rising costs in comparison to sales. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we discuss the state of digital phenotyping, plus the vaccine patent lawsuits, the smallest insulin pump, and the rest of the week's headlines. |
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Thursday, August 17, 2023 | 11am ET / 8am PT In this webinar, we will discuss the challenges and opportunities for WGBS in an era of cost-effective sequencing: Optimizing protocols and reagents for consistent and reliable results, establishing community standards to ensure WGBS library quality, and more. Register now.
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Webinar Download this webinar to learn how to avoid pitfalls when characterizing CAR-T cells in your development workflow, how to save time by using one antibody to examine your entire panel of CARs, and more. Sponsored by: Cell Signaling Technology |
Whitepaper Learn more about the current challenges and issues that eClinical technology providers are facing. Sponsored by: YPrime |
Research The right sourcing strategy can help save of millions of dollars—learn about developing a strategy for sourcing the cGMP chemicals critical to your processes. Sponsored by: Thermo Fisher Scientific Production Chemicals and Services |
Whitepaper Learn how a GPCR-focused library with a cell-based biopanning strategy led to the discovery of 13 high-affinity and selective anti-GLP-1R antibodies with highly developable therapeutic properties. Sponsored by: Twist Bioscience |
eBook This eBook identifies the trends driving major change in the Medical Affairs (MA) function. It also outlines the strategic and tactical implications for MA leaders and team members. Sponsored by: Blue Matter, strategic consultants in the life sciences |
eBook Take a look at the reporting tools sponsors need to access insights earlier in the clinical trial enrollment funnel, so you can take informed actions. Sponsored by: OneStudyTeam |
Whitepaper Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your bioprocessing workflows. Sponsored by: Thermo Fisher Scientific Production Chemicals and Services |
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