| Editor’s note: This is the last edition of Fierce PM Tracker for 2023. The Fierce team is taking a break from the regular newsletter schedule until Jan. 2, but be sure to check our sites for the biggest headlines until then. Enjoy your holiday season, and best wishes for the coming year. |
Today’s Big NewsDec 22, 2023 |
| By Annalee Armstrong Christmas has come early for Karuna Therapeutics’ shareholders. Bristol Myers Squibb has unwrapped a $14 billion deal to acquire the biotech, which sits on the cusp of having the first schizophrenia treatment approved in years. |
|
|
|
By Zoey Becker The approval in hereditary transthyretin-mediated amyloid polyneuropathy, which affects around 40,000 to 50,000 patients globally, sets the stage for a potential label expansion down the line to treat the broader transthyretin amyloid cardiomyopathy patient population. |
By Andrea Park Commercial green lights have largely failed to translate into profitability for makers of digital therapeutics, many of whom found themselves struggling to stay afloat this year. |
By Gabrielle Masson It’s been a trying 2023 for Mersana Therapeutics and the year doesn’t appear to be ending on a high note. The antibody-drug conjugate (ADC) biotech and Merck KGaA have severed ties for a licensing pact related to one of Mersana’s tech platforms. |
|
Tuesday, January 23, 2024 | 11am ET / 8am PT Join a cutting-edge conversation on January 23, 2024 with Real Chemistry and Quid as they explore how their partnership has forged a deeper understanding of patient insights. Register now.
|
|
By Eric Sagonowsky Based on the series of measures centered on U.S. drug prices coming out of Washington, the Biden administration is clearly emboldened on the topic. |
By Ayla Ellison,Annalee Armstrong,Gabrielle Masson This week on "The Top Line," Fierce Biotech staff writer Gabrielle Masson and senior editor Annalee Armstrong look back at the year in biotech, which was defined by massive layoffs across the industry. They also discuss their favorite stories of the year, including an appearance from a popstar whose reputation precedes her. |
By Angus Liu As the FDA investigates a safety signal for approved CAR-T therapies, the agency has elevated a warning about secondary cancers following the use of Johnson & Johnson and Legend Biotech’s Carvykti. |
By Conor Hale While AI has already made a deep impact on healthcare, the spotlight on programs such as ChatGPT has led to new debates on AI ethics and safety. |
By James Waldron AlloVir’s ambitions, like its share price, have shrunk significantly as the biotech abandons three late-stage trials of its lead asset after deciding none were likely to achieve success. |
By Kevin Dunleavy Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise. And it is with cautious optimism that industry watchers see the trend continuing in 2024. |
Fierce podcastsDon’t miss an episode |
| | This week on "The Top Line," Fierce Biotech staff writer Gabrielle Masson and senior editor Annalee Armstrong look back at the year in biotech, which was defined by massive layoffs across the industry. They also discuss their favorite stories of the year, including an appearance from a popstar whose reputation precedes her. |
|
|---|
|
|
|
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.
|
|
| WhitepaperDownload this whitepaper to discover the 3 pillars of successful PK testing and conquer bioanalytical challenges. Sponsored by: Sannova Analytical |
| WhitepaperThe 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 |
| WhitepaperqPCR Assay Design - Quantify microbial biomarkers with high sensitivity and dynamic range Sponsored by: Diversigen |
| WhitepaperStreamline 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 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 SummaryBy 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 |
| WhitepaperLearn 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 |
| eBookEmulate in vivo biology with next-generation in vitro technology. Sponsored by: Emulate |
| |
|
