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These awards honor CROs that excel in innovation, quality, and leadership, highlighting their crucial role in advancing life sciences and improving patient outcomes. Enter now!
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Today’s Big NewsOct 8, 2024 |
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De-risk clinical trials with Foresight CLARITY’s ultra-sensitive MRD detection. Foresight CLARITY is IUO-ready for prospective trials through our CLIA-registered central lab. Learn more about Foresight CLARITY™️.
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| By Gabrielle Masson A new RNAi biotech is breaking ground with $135 million and John Maraganore, Ph.D., holding the key to the city. |
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By Fraiser Kansteiner Pfizer—which opened a global hub in Tampa, Florida, in 2021—is setting out to bolster emergency services, pool donations and ease medical supply needs as Hurricane Milton touches down this week. |
By Kevin Dunleavy A compounding industry group has sued the FDA, claiming its action to remove Eli Lilly’s Mounjaro and Zepbound from its drug shortage list is a “reckless and arbitrary decision—lacking any semblance of lawful process.” In declaring the end of the shortage, the FDA has halted the ability of compounding pharmacies to manufacture the in-demand products. |
By Conor Hale Previous over-the-counter tests had been granted emergency authorizations. The Rapid Check screener from Healgen received a de novo clearance. |
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Wednesday, October 16, 2024 | 2pm ET / 11am PT Join experts as they delve into the distinct strategies required for developing ADCs and RIT, focusing on how medical imaging can accelerate clinical trials and drug approval. Register now to gain practical insights into optimizing clinical trials and advancing cancer therapies through cutting-edge imaging techniques.
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By Nick Paul Taylor The sun has set on Johnson & Johnson’s SunRISe-2 study. J&J called a halt to the phase 3 bladder cancer trial after an interim look at the data showed the TAR-200 candidate was no better than chemoradiation. |
By James Waldron Mestag has been working to change how fibroblasts are activated and how they expand. Now, Merck & Co. wants in—penning a $1.9 billion biobucks deal to collaborate on new therapies for inflammatory diseases. |
By Fraiser Kansteiner GSK on Tuesday unveiled fresh data from the late-stage AReSVi-006 study of Arexvy in RSV-triggered lower respiratory tract disease in older adults over the span of three full RSV seasons. The positive readout comes several months after the CDC voted to narrow vaccine recommendations for the virus. |
By Nick Paul Taylor Sage Therapeutics has seen another clinical trial go up in smoke. The biotech called time on its plans to develop dalzanemdor in Alzheimer’s disease after seeing midphase data, adding to an earlier Parkinson’s flop and leaving the team looking to an upcoming readout in Huntington’s to rescue the prospect. |
By Angus Liu Merck & Co. hopes a new positive readout can return Keytruda to glory in head and neck cancer about two years after a prior failure. |
By Darren Incorvaia GEMMABio, one of two new companies spun out of the now-folded Gene Therapy Program at the University of Pennsylvania, has announced its first major step in improving global access to rare disease gene therapies. |
By Conor Hale Medtronic has been notifying users of its MiniMed insulin pumps to be aware of potentially shortened battery lives, and to heed the devices’ low-power warnings and alerts. |
By Ben Adams A new survey commissioned by Big Pharma Roche has found that half of those polled “have either limited or no awareness” of the connection between a common infection and cervical cancer. |
By Nick Paul Taylor Bausch + Lomb has teamed up with American sportscaster Erin Andrews to promote its dry eye disease treatment, launching the “Miebo ohh yeah” campaign to spread the word about the condition and drug. |
By Andrea Park Eversana is increasing its reach across the global pharmaceutical industry. With the opening of its first office in Germany, the provider of commercialization services now has a presence in four of the world’s five biggest pharma markets. |
Fierce podcasts Don’t miss an episode |
| This week on "The Top Line," Fierce Pharma’s Fraiser Kansteiner and Arnold & Porter’s Dan Kracov break down the BIOSECURE Act's potential impact on the life sciences industry and what comes next after the House of Representatives' recent vote. |
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Wednesday, October 23, 2024 | 11am ET / 8am PT Large, deeply characterized patient cohorts are one of the most promising data resources today for understanding disease biology and developing new medicines. Join us as we explore how this data is driving the next generation of pharmaceutical development. Learn how to leverage genetic research in today's highly competitive landscape. Register now.
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eBook Need the superpowers to select the right lab equipment? Sponsored by: PHC Corporation of North America |
Whitepaper Take a brief journey through some of the efforts that Lonza has made to optimize the manufacturability of bsAbs and other formats, and take a glance towards future directions with an emphasis on the upstream aspects. Sponsored by: Lonza |
Whitepaper How can an emerging company attract the right partner for a therapeutic asset (& optimize its value in a transaction)? This paper offers some insights. Presented by: Blue Matter |
Whitepaper Unlock the Future of Biotherapeutics with Catalent Biologics! Sponsored by: Catalent Biologics |
Whitepaper Finding an effective epilepsy treatment can be arduous. Download this brochure to delve into how IQVIA's expertise and innovative strategic approach can streamline the clinical trial process, helping to get new therapies to patients who need them sooner. Sponsored by: IQVIA |
Whitepaper When the fate of your company hangs in the balance, you need expert guidance to navigate the complexities of biotechnology development and to make informed decisions. Sponsored by: WCG |
Whitepaper Power non-invasive, self-sampling solutions using the Colli-Pee™️ first-void urine collection device. Learn more. Sponsored by: DNA Genotek |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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| The Lighthouse at Pier 61 in New York City |
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