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Septemeber 8-11, 2025 | Philadelphia, PA Where biotech breakthroughs meet pharma scale. Dive into dynamic discussions on translational science, dealmaking, and the innovation shaping the next generation of therapies. Register now to connect and collaborate. .png)
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Today’s Big NewsJun 5, 2025 |
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Monday, June 16, 2025 | 12pm ET / 9am PT Join a candid and informative discussion between precision medicine experts. They will share lessons learned and concrete opportunities to transform clinical trial design, execution and outcomes. Register now. 
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| By Darren Incorvaia At a June 5 cell and gene therapy roundtable hosted by the Food and Drug Administration, Health Secretary Robert F. Kennedy, Jr., asked the assembled scientists and advocates to provide a list of regulations they’d like to see gone. |
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By James Waldron Cullinan Therapeutics is paying $20 million upfront for a BCMAxCD3 bispecific T-cell engager that the biotech plans to pair with its existing CD19 candidate. |
By Zoey Becker The Council of the European Union has delivered its newest set of proposals meant to shake up European pharma regulations and sharpen its competitive edge, but the plan isn't exactly what EU drugmakers had hoped for. |
By Heather Landi Startup Clairity scored a green light from the FDA for the agency's first artificial intelligence tool designed to predict five-year breast cancer risk from a routine screening mammogram. |
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Wednesday, June 11, 2025 | 11am ET / 8am PT Join us for a deep dive into the strategies and best practices for maximizing valuation by improving productivity in modern clinical trials. We'll discuss key ways to achieve tangible productivity gains, accelerate timelines, and avoid costly protocol amendments or clinical failures. Register now to learn expert tips for maximizing efficiency and effectiveness. 
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By Nick Paul Taylor RegenXBio has shared updated phase 1/2 data on its Duchenne muscular dystrophy (DMD) gene therapy, providing evidence that its pivotal dose improves functional outcomes in older boys with the disease. |
By Nick Paul Taylor Orca Bio is preparing to make a splash in the cell therapy market. The biotech has hired Steve Gavel as chief commercial officer, securing itself a leader with cell therapy expertise accrued at Legend Biotech and Celgene. |
By Fraiser Kansteiner Schott Pharma—which makes glass vials, syringes, delivery devices and other key packaging products for the pharmaceutical industry—is investing more than 100 million euros ($115 million) at its manufacturing site in Lukácsháza, Hungary, to build a new facility focused on sterile ready-to-use cartridges. |
By Andrea Park After a long winter, the start of summer is ushering in some much-needed sunshine, warmer weather and, for a handful of biopharma companies, refreshed branding. |
By Kevin Dunleavy Amneal Pharmaceuticals is recalling three lots of sulfamethoxazole/trimethoprim tablets because of microbial contamination which caused black spots to appear on the medication, according to a report from a customer. |
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. |
By Heather Landi Smiths Medical has recalled ambulatory infusion pumps to provide updated use instructions to providers after identifying issues with potential false alarms as well as two other problems that could pose safety risks. |
Fierce podcasts Don’t miss an episode |
| This week on "The Top Line," we break down first-quarter Big Pharma earnings, recap the latest gene therapy developments and preview what’s ahead at ASCO. |
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Tuesday, June 17, 2025 | 11am ET / 8am PT Join experts from NIBRT and Securecell AG to explore how advanced Process Analytical Technologies (PAT) are transforming bioprocessing. Register now. 
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Whitepaper We analyzed ~300 launches to identify the factors most correlated with commercial success & built a framework for peak go-to-market performance. Presented by Blue Matter, strategic consultants in the life sciences |
| The Lighthouse at Pier 61 in New York City |
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