| Today’s Big NewsApr 3, 2024 |
| By Angus Liu As new cancer vaccines—led by Moderna and Merck’s mRNA-4157—near pivotal trial readouts, the FDA’s vaccines czar Peter Marks said the agency is ready to review the shots despite AI-related unknowns. |
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By Zoey Becker Four dose strengths are now expected to be in short supply through April, according to the FDA. The agency previously expected the squeeze to let up at the end of March. |
By Conor Hale The Rejoyn app aims to further reduce major depressive disorder symptoms by complementing standard antidepressants, with a six-week digital treatment schedule. |
By Nick Paul Taylor Genmab is mounting a $1.8 billion challenge against its close collaborator AbbVie. The Danish biotech is using the money to buy ProfoundBio and gain control of a midphase antibody-drug conjugate that could compete against AbbVie’s Elahere. |
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Thursday, April 11, 2024 | 11am ET / 8am PT As clinical trials increase in complexity, drug developers face growing pressure to deliver on-time, on-budget studies. FSP partnerships have emerged as a pivotal strategy to help address current challenges. Join us to learn moreas we explore the findings of The 2024 FSP Trends Report from the PPD clinical research business of Thermo Fisher Scientific. Sign up now!
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By Ben Adams It’s March, so it’s time for some #FierceMadness. Last year, we channeled the NCAA tournament for the best pharma ad campaigns, but this year we’re looking for the best of the best in drug names. |
By Annalee Armstrong The biggest M&A deal of the quarter award goes to Gilead Sciences, which acquired CymaBay Therapeutics for $4.43 billion in February. The largest—and first—IPO was CG Oncology, which had a total transaction value of $380 million. |
By Fraiser Kansteiner Demand fluctuations have spurred Thermo Fisher Scientific to downsize at the plasmid DNA manufacturing facility the company opened a little less than three years ago, putting jobs on the chopping block. |
By Conor Hale The German medtech staked its claim for Asensus with a deal to buy out all its shares at 35 cents apiece, representing a 66.7% premium over its recent trading price of 23 cents—for a total in the ballpark of $95 million. |
By Nick Paul Taylor Novo Nordisk has emerged unscathed from a probe into claims it ran an “orchestrated PR campaign” to shape the obesity debate in the U.K. The U.K. drug promotion watchdog carried out the investigation in response to media reports about Novo’s links to experts but found no evidence of wrongdoing. |
By Annalee Armstrong,Max Bayer,Gabrielle Masson,James Waldron What's the best biotech name? It's time to vote in the Fierce Madness #biotechbracket. |
By Kevin Dunleavy Fifteen years after gaining its first FDA approval for Fanapt (iloperidone) to treat schizophrenia, Vanda Pharmaceuticals has scored again with the same antipsychotic drug. The FDA has signed off on Fanapt tablets to treat adults with manic or mixed episodes associated with bipolar I disorder. |
By Andrea Park As April’s National Minority Health Month begins, Johnson & Johnson is picking up the pace in its “race to health equity.” |
By Max Bayer Oruka Therapeutics is jumping onto the biotech stage with a bang, going public via a reverse merger and tacking on $275 million through a private placement. |
By Nick Paul Taylor Gilead is bringing its HIV awareness campaign to the ballroom, partnering with actor and dancer Jason A. Rodriguez for a workshop about the dance style voguing and sexual health. |
Fierce podcastsDon’t miss an episode |
| | This week on "The Top Line," we explore our annual special report on the top money raisers in the biotech industry. Which company raised the most funding in 2023? What does the biotech financing landscape look like for this year? Fierce Biotech's Annalee Armstrong and Max Bayer answer those questions and many more in today's episode. |
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Available On-Demand Navigating the complexities of the rapidly evolving landscape of cell therapy manufacturing poses significant challenges. Access this discussion on-demand to learn more about the top challenges cell therapy developers are facing. We explore the need for closed, automated, and flexible manufacturing workflows that are designed to de-risk the process for clinical and commercial success. View now.
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| WhitepaperThis paper assesses the current state of the oncology market, reviewing key expectations for 2024. It addresses CAR-T therapies, KRAS, radiopharmaceuticals, & targeted protein degradation. Presented by Blue Matter, strategic consultants in the life sciences |
| WhitepaperChoosing the right contract lab can help drug developers accelerate their timelines and generate cost-efficiencies. For insights into what to look for when selecting a GMP/CMC lab partner read this white paper which delves into a range of factors that can support your needs in both the short-term and in planning for the future. PPD®️ Laboratory Services |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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