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Wednesday, May 14, 2025 | 11am ET / 8am PT Biotech success isn’t just about great science—it’s about building a compelling commercial narrative from day one. Join us to explore how early commercialization planning, powered by real-world insights, can maximize an asset’s potential. Our discussion will uncover strategies to integrate commercial thinking into R&D. Register now.
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Today’s Big NewsMay 2, 2025 |
| By Gabrielle Masson The leaked drafts have proven true. President Donald Trump’s proposed federal budget for 2026 would nearly halve funds for the National Institutes of Health, dropping the agency’s financing from about $48 billion to $27 billion. |
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By Angus Liu Since its historic FDA approval in March 2024 as the first medication for MASH, Madrigal’s Rezdiffra has handily beat Wall Street’s sales projections for the fourth straight quarter. |
By Conor Hale Following the launch of two new cancer tests—plus a third planned for before the end of 2025—Exact Sciences is nudging up its financial expectations. |
By Andrea Park Amid the launch of its non-opioid pain med Journavx, Vertex Pharmaceuticals has begun an awareness-raising blitz focused on acute pain management. |
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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 Emma Beavins President Trump sent his annual budget request to congressional appropriators on Friday morning. The document is a wish list for the discretionary spending cuts the executive branch wishes to see Congress make in annual appropriations. |
By Fraiser Kansteiner Bristol Myers Squibb will cease production of viral vectors from its plant in Libertyville, Illinois, the company has told Fierce Pharma. The facility, which was previously used by Novartis to manufacture the gene therapy Zolgensma, was picked up by BMS in early 2023 to bolster viral vector capacity for its commercial cell therapy portfolio. |
By Ben Adams To REMS, or not to REMS. That, apparently, was the question for Cytokinetics, which has seen any potential approval for its experimental heart drug delayed by an extra three months over an unusual safety program omission and addition. |
By Conor Hale HistoSonics is shopping for a potential buyer of its approach to destroying liver tumors with focused sound waves, according to the Financial Times. |
By Zoey Becker This year's 24 Hours of Le Mans endurance car race in France in June will see a United Autosports McLaren clad with a Sanofi-created meningitis awareness flag in a campaign meant to illustrate how "every second counts" when it comes to meningitis. |
By Kevin Dunleavy While Amgen’s legacy products are thriving, those gained from the company’s $27.8 billion buyout of Horizon Therapeutics in 2023 are struggling, especially blockbuster eye disease treatment Tepezza, which saw a 17% sequential decline in the first quarter. |
By Darren Incorvaia The National Institutes of Health is making a major change to how grant recipients can use their funds. The agency plans to end the subaward process that has been under increased scrutiny since the beginning of the COVID-19 pandemic. |
By Andrea Park Far from doffing their caps to actinic keratosis (AK), dermatology drug developers Almirall and Biofrontera are keeping things firmly covered to raise awareness of the skin cancer precursor. |
By Darren Incorvaia Eighteen years ago, Tim Friede began willingly injecting himself with escalating doses of venom from 16 snake species. Now, antibodies in his blood have led to the development of a three-part antivenom cocktail capable of protecting mice from the toxins of 19 dangerous snakes. |
By Kevin Dunleavy Reductions in staff at the FDA are putting pressure on biotech companies, especially those strapped for cash, and could lead to more M&A activity, according to Andrew Goodman, a partner in the M&A practice at business law firm Paul Hastings. |
By Gabrielle Masson The FDA has freed Amgen’s mysterious early-stage obesity asset from a clinical hold, with the phase 1 study now enrolling participants. |
By Darren Incorvaia,Zoey Becker,Gabrielle Masson Scholar Rock is shaking up its executive team as it prepares to enter the commercial arena with the expected launch of spinal muscular atrophy drug apitegromab later this year. CEO Jay Backstrom, M.D., is stepping down, making room for longtime board chairman David Hallal to take over. Hallal previously spent more than a decade in C-suite roles at what is now AstraZeneca’s Alexion, culminating in nearly two years as CEO. |
By Angus Liu Akeso's first overall survival readout for its Keytruda challenger caused a violent market reaction. AstraZeneca disclosed another potential fine in China. Ono unveiled layoffs in a notice filed in Massachusetts. And more. |
Fierce podcastsDon’t miss an episode |
| This week on "The Top Line," hear how the founders of ElevAAte are turning shared East Asian American experiences into collective power for the next generation of biopharma leaders. |
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Tuesday, May 20, 2025 | 11am ET / 8am PT This webinar will feature industry experts discussing the power of combining biomedical data analysis with matched tissue and molecular samples. Register today to learn more.
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| WhitepaperWe interviewed 24 Medical Affairs leaders on the critical success factors for building a Best Practice Medical Affairs organization. This report shares what we learned. Presented by Blue Matter, strategic consultants in the life sciences |
| eBookTypical 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 |
| WhitepaperIs 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 |
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