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Monday, April 21, 2025 | 12pm ET / 9am PT Join us for an exclusive webinar exploring groundbreaking findings from the DUTRENEO trial, which evaluated the role of predictive biomarkers in guiding neoadjuvant therapy for muscle-invasive bladder cancer (MIBC). Register today. 
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Today’s Big NewsApr 18, 2025 |
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Thursday, April 22, 2025 | 11am ET / 8am PT Digital transformation is the way of the future, but knowing where and how to start the journey toward digital evolution can be challenging. Join us for key insights on digital strategies that can help you overcome the inefficiencies in traditional methods of process development and biomanufacturing. Register now. 
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| By Kevin Dunleavy The tortoise (Eli Lilly) has caught the hare (Novo Nordisk), according to a report from BMO Capital Markets, which cites the superior commercial and clinical portfolios of the Indianapolis company compared to those of its Danish rival. |
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By Gabrielle Masson Employees of companies regulated by the FDA—such as pharmas or biotechs—are no longer allowed to serve as members of FDA advisory committees, according to a new directive from the agency's commissioner. |
By Nick Paul Taylor Alis Biosciences has made a pitch to the hundreds of biotechs that are valued at less than the cash they have in the bank. The investment fund is proposing to buy the companies and return most of their cash to shareholders, offering them an alternative to exits such as reverse mergers and liquidations. |
By Kevin Dunleavy Sanofi and Regeneron have scored an FDA approval for Dupixent in its seventh indication—chronic spontaneous urticaria (CSU). The nod comes 18 months after the U.S. regulator rejected Dupixent in the same indication. |
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Tuesday, May 6, 2025 | 9am ET / 6am PT This webinar will explore how to use AI-driven tools for timely data-driven decisions that are critical to securing approvals, expediting market entry and sustaining competitive strength. Register now. 
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By Fraiser Kansteiner Staff cuts at the FDA have reached key negotiators in charge of hashing out terms with the industry to renew the agency's user fee collection program, which helps fund the FDA and keeps its drug review process on track, Reuters reports. |
By Gabrielle Masson Biotechs will need to be strategic to achieve “tariff-era success” as the sector enters an “America-first resurgence,” according to a new report from PitchBook. Companies focused on AI integration and manufacturing innovation are expected to win out, according to the firm. |
By Conor Hale As it aims to broaden the reach of its replacement heart valves among younger patients, Edwards Lifesciences has put forward new clinical data showing its bioprosthetics can maintain their function over the long term. |
By Darren Incorvaia,Zoey Becker Just a few weeks after closing a $155 million series B, RNA editing biotech AIRNA is bringing an experienced gene therapy developer on board to help get the company’s first candidate into the clinic. |
By Nick Paul Taylor VelaVigo Bio has landed its second deal in six months, offloading ex-China rights to a bispecific to Ollin Biosciences for up to $440 million. |
By Nick Paul Taylor The U.S. government has pulled the rug out from under Pluri Biotech’s PLX-R18 cell therapy. Having put up funding to help bring the candidate to market, the government terminated the contract in a move that Pluri believes “may reflect broader federal budgetary and administrative adjustments." |
By Fraiser Kansteiner,Eric Sagonowsky,Angus Liu,Zoey Becker,Kevin Dunleavy In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning. |
Fierce podcasts Don’t miss an episode |
| This week on “The Top Line,” we unpack the latest tariffs from the Trump administration and their potential impact on the life sciences industry. |
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Scaling advanced biotherapeutics is becoming more complex due to the rise of therapies like cell and gene treatments, RNA therapeutics and monoclonal antibody variants. Access this report to discover key strategies to optimize production, ensure compliance and accelerate commercialization. Download now. 
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eBook Typical vaccine development timelines have averaged 10 years, but the time from the SARS-CoV-2 genetic sequence’s release to the submission of the first vaccine clinical trial data for regulatory review was a mere 314 days. In IQVIA Laboratories’ Vaccine eBook we focus on how contract research organizations (CROs) can best leverage strategic partnerships with sponsors to prepare for the next pandemic. Sponsored by: IQVIA |
Whitepaper Is your clinical trial data truly reliable? Learn how a combined approach using Imaging Core Labs and Endpoint Adjudication Committees (EAC) can minimize risk, control costs, and strengthen your study from the ground up. Don’t leave success to chance—arm yourself with the insights to stay ahead. Sponsored by: WCG |
Research We interviewed 15 biopharma leaders on the critical success factors for building a Best Practice customer-facing organization. This report shares what we learned. Presented by Blue Matter, strategic consultants in the life sciences |
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