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May 1 - 3, 2023 | Jersey City, NJ Connect with senior executives in Medical Affairs, MSL and IIT to share best practices. Register Today & save $200 from now until April 7th!
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Today's Big NewsMar 31, 2023 |
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Download the white paper by VeriSIM Life CSO Dr. Szczepan Baran and Peter Henstock, Machine Learning/AL Lead at Pfizer, to better integrate AI across R&D. Where to start, how to benchmark & more. Download Now.
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| By Annalee Armstrong Eli Lilly’s up-and-coming Alzheimer’s disease treatment remternetug seems to have resulted in an early, dose-dependent reduction in amyloid plaques during a small phase 1 study. But the therapy also ran into a common side effect for the anti-amyloid monoclonal antibody class—although it is early days for the data. |
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By Eric Sagonowsky In the wake of a fight over board control with activist investor group Sarissa Capital, Amarin's CEO Karim Mikhail has abruptly left the drugmaker. The company intends to fight its former helmsman on severance payments. |
By Andrea Park Just a few weeks after a Kaiser Health News report uncovered a spate of complaints about the unregulated use of a dental device that patients say caused extensive damage, the FDA has begun looking into the issue. |
By Nick Paul Taylor Galapagos is taking a leaf out of the Sanofi playbook for offloading unwanted French R&D units. Seeking to slim down to execute its new strategy, the Belgian biotech has struck a deal to transfer a facility on the outskirts of Paris to the drug discovery contract research organization (CRO) NovAliX. |
By Kevin Dunleavy Slowly but surely, Sanofi is carving up its consumer healthcare business in an ongoing push to streamline and focus on the high-risk, high-reward pharma sector. Now the French company is spinning off its consumer unit in India, according to a report in the Economic Times. |
By Andrea Park Phenomix Sciences claims to have cracked the biological code on matching patients to the most promising weight-loss treatments, based on a combination of genetic, environmental and behavioral factors. |
By Nick Paul Taylor Molecular Templates is fighting for survival. Facing threats that could sink the business, the Bristol Myers Squibb-partnered biotech is halving its 222-person team, stopping clinical development of a HER2 drug candidate and focusing its preclinical work on collaborations. |
By Fraiser Kansteiner The Biden Administration’s solicitor general, Elizabeth Prelogar, told the Supreme Court that the case is a “suitable vehicle” to address the argument over skinny labels. |
By Conor Hale Dubbed the Epic Max, the valve is recommended for patients who need a replacement but shouldn’t take a regimen of blood thinners. |
By Angus Liu In the latest example of biopharma's ongoing investment in cell and gene therapy production, Sartorius has agreed to acquire French viral vector expert Polyplus for $2.6 billion. But there are some signs of cooling in the field. |
By Max Bayer Cytokinetics' commercial ambitions met another late-stage stonewall, with the company’s amyotrophic lateral sclerosis (ALS) prospect coming up short when investigators took a look under the clinical hood. |
Fierce podcastsDon't miss an episode |
| | This week on "The Top Line," we discuss how 2023 is shaping up to be much the same as last year when it comes to financing trends for biotechs. We also cover Emergent's Narcan winning the first over-the-counter approval for an opioid-overdose drug and more of this week's top headlines. |
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Thursday, April 6, 2023 | 11am ET / 8am PT In this webinar, we show how we used Nunchuck to make LNPs in small-volume screening runs and bulk formulations. The complete workflow will be illustrated, from the testing of flow rates in initial formulations to the final assessment of mRNA expression in multiple cell types, showing successful transfection of cells by the LNPs. Register now.
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| WhitepaperPreparation of critical process liquids and buffer components shifts resources away from core activities and can be filled with inefficiencies and risks that can increase time and costs across your workflow. Learn about the framework to help reduce your total costs beyond capital and operational expenditures and set a solid foundation for successful scale-up of buffer preparation. Sponsored by: Thermo Scientific Production Chemicals and Services |
| WhitepaperThis paper describes the key elements of good US/EU corporate governance for US-based biopharma companies in operating Europe. Sponsored by: Blue Matter, strategic consultants in the life sciences |
| Executive SummaryRead about the latest survey results from over 200 biopharma executives and the changing approaches to building biologic drug development pipelines. Sponsored by: Twist Bioscience |
| WhitepaperHave you had your questions about mRNA/saRNA manufacturing unanswered during a webinar; have no fear, we have you covered here. Sponsored by: Aldevron |
| Whitepaper Download Herspiegel Consulting’s Go-To-Market Model, based on 100+ launches, to learn the critical components, and timelines for commercial success. Sponsored by: Herspiegel Consulting |
| WhitepaperWhat are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
| WhitepaperExplore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
| Research Learn more on Catalent’s step-wise approach for the definition and execution of Process Characterization for the production of a monoclonal antibody for late phase process characterization and development. Sponsored by: Catalent |
| Case Study Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
| WhitepaperDiscover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
| Whitepaper As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs. Sponsored by: Catalent |
| Research Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
| WhitepaperFor sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management. Sponsored by: Catalent |
| WhitepaperLearn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region. Sponsored by: Catalent |
| WhitepaperHow can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis. Sponsored by: Catalent Clinical Supply |
| WhitepaperPlanning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial. Sponsored by: Catalent |
| WhitepaperExplore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world. Sponsored by: Catalent |
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