| Today's Big NewsApr 17, 2023 |
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An ideal home for reshoring. U.S. manufacturers gain greater control of and visibility into their supply chains, as well as access to a robust STEM talent pool, by setting up operations in Puerto Rico. 
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| By Annalee Armstrong KRAS inhibitors arrived on the market in May 2021 and December 2022 to much fanfare—but if you ask Eli Lilly’s Loxo unit, the therapies have left much to be desired. |
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By Angus Liu While Len Schleifer and George Yancopoulos founded Regeneron, it was Roy Vagelos who molded the biotech into the company we know today. Now, after a long and fruitful 29-year run, Vagelos, 93, is retiring as Regeneron’s chairman. |
By Andrea Park Between a range of collaborations across healthcare, pharma and medtech, and its own product development in the space, Amazon has spent the last few years moving further and further into the world of medicine—and a newly announced partnership is strengthening its foothold in the industry. |
By Angus Liu Eli Lilly’s plan for two new manufacturing sites in its home state Indiana now totals $3.7 billion in investments. Thanks to an additional $1.6 billion, Lilly is making the largest manufacturing investment at a single location in the company’s near-150-year history. |
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Tuesday, May 23, 2023 | 2pm ET / 11am PT Clinical trials are complex, time-consuming, and costly. But what if you could use simulation to guide your decisions and optimize your trial design? In this webinar, we'll discuss the power of simulation-guided trial design (SGTD) and explain its benefits to clinical development strategies. Register now to join us. 
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By Nick Paul Taylor Merck & Co. is paying $10.8 billion to buy Prometheus Biosciences for its late-phase bowel disease drug candidate. Months after midphase data sent Prometheus’ stock spiraling upward, Merck has agreed to a 75% premium over the biotech’s prior closing price to land a challenger to Roivant Sciences’ RVT-3101. |
By Zoey Becker After Amarin's spat with shareholder group Sarissa Capital, the Vascepa maker has revealed the names of its new interim CEO and board member. |
By Conor Hale Dubbed CardioSeq, the study will examine the genetic traits of 1,500 patients and their links to heart disease and treatment side effects. |
By Max Bayer Merck and Moderna are rapidly accelerating plans for a phase 3 trial of their cancer vaccine-Keytruda combo, hoping to launch a phase 3 trial before the end of the year. The companies found that the combination reduced the risk of recurrence or death in patients with melanoma by 44% compared to Keytruda alone. |
By Angus Liu AstraZeneca has offered the first look at the benefit of a PD-1/L1 inhibitor when used both before and after surgery in resectable non-small cell lung cancer. But the data raise more questions than answers. |
By Gabrielle Masson The pressure to perform is building for Affimed as its investigational lymphoma treatment fails to beat current standard-of-care treatments, prompting the German biotech to pursue a new path for its lead asset. |
By Andrea Park With a pivotal trial of its neuromodulation treatment for Alzheimer’s disease underway—and backed by a fresh influx of more than $70 million in VC funding—Cognito Therapeutics is now in the process of strengthening its C-suite. |
By Conor Hale The collaboration will begin by focusing on “selected opportunities” in the field, such as determining the antibiotic resistance of tuberculosis cases or screening for hidden pathogens in sterile samples. |
By Annalee Armstrong,Gabrielle Masson,Max Bayer We had hoped that our Layoff Tracker would stay retired for a while, but 2023 is starting to look a lot like our old friend 2022 when it comes to layoffs in biotech. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we talk about biotech’s top money raisers in 2022. We also cover J&J's talc litigation, prison plans for Elizabeth Holmes and more of this week's top headlines. |
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Wednesday, April 26, 2023 | 12pm ET / 9am PT Our speakers will explore how science-based organizations are producing more data than ever before, and why digital transformation strategies to leverage this data, like AI and machine learning, require the right infrastructure of connected, searchable, and harmonized data. Register now. |
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Research Read the results of a two-phase scale-up strategy used to help decrease risk and ensure consistency in complex dry powder media formulations produced within customers’ specifications and timelines. Sponsored by: Thermo Fisher Scientific |
Whitepaper How can eConsent provide a more flexible approach to informed consent? Sponsored by: YPrime |
Whitepaper The preclinical hematotoxicity screening method that helps clients eliminate bad players earlier in the drug development process Sponsored by: ReachBio | The Cell Biology Experts™ |
Whitepaper We’ve identified four must-have tools to manage today’s scientific information chaos. How many are you utilizing? Sponsored By: CCC |
Whitepaper How advanced medicines commercial readiness differs and the resources needed to maximize potential. Sponsored by: Herspiegel Consulting |
Whitepaper This paper outlines an approach that digital health / therapeutics companies can use when developing a go-to-market strategy for the complex US market. Presented by Blue Matter, strategic consultants in the life sciences |
Whitepaper Preparation 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 |
Whitepaper Explore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
Whitepaper Discover 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 |
Whitepaper For 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 |
Whitepaper Learn 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 |
Whitepaper How 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 |
Whitepaper Planning 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 |
Whitepaper Explore 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 |
| May 1-3, 2023 | Jersey City, NJ |
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