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Thursday, June 6, 2024 | 11am ET / 7am PT Assessment of antibody off-target reactivity is a regulatory requirement for clinical development. However, conventional screening methods are often ineffective in screening newer therapeutic modalities, and their predictive value for in vivo safety and toxicity is poor. Join us for a look at the new alternatives for success. Register now.
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Today’s Big NewsMay 31, 2024 |
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Wednesday, June 12, 2024 | 11am ET / 8am PT If you are a company developing gene therapies, don’t miss this opportunity to learn about containment and aseptic filling solutions – how to prepare for fill finish early and ensure products are ready to ship immediately upon approval, providing life-saving drugs to patients as quickly as possible. Register now.
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| By Eric Sagonowsky Ever since the COVID-19 pandemic began to ease, Moderna has weathered a sharp revenue downturn. But a new FDA approval shows that the company's scientific engine is no one trick pony. |
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By Annalee Armstrong A Special Report from the Fierce Biotech team on the state of cell therapy. |
By Conor Hale ACLA said the agency overstepped when it announced it would regulate all in vitro diagnostics with the same approach it uses for medical devices. |
By Angus Liu Gilead Sciences is drawing back the curtain on the Trodelvy lung cancer data that previously caused a 10% slide in the company’s stock price. In sharing the detailed results, the company is hanging onto a positive sign in a subgroup of patients who have a high unmet medical need. |
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Wednesday, June 19, 2024 | 10am ET / 7am PT Join us for a one-hour discussion on oral cyclic peptide drug development. Learn about key industry breakthroughs that demonstrate results. Register now!
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By Zoey Becker Newly diagnosed chronic myeloid leukemia patients on Scemblix achieved a major molecular response rate of 68% at 48 weeks compared to 49% for older drugs, including Novartis' established Gleevec. |
By Conor Hale The startup said it has claimed the world record for the number of electrodes used to detect a person’s brain activity. |
By Andrea Park Ahead of the kickoff of June’s annual Pride Month, the American Cancer Society has published a report examining cancer risk in the LGBTQ+ community—and concluding with a call to action to lower the likely heightened risks among the population. |
By Fraiser Kansteiner In the phase 3 HARMONi-2 trial, solo ivonescimab delivered a statistically significant and clinically meaningful improvement in progression-free survival (PFS) over Keytruda monotherapy. Summits shares spiked by about 270% on Thursday. |
By Annalee Armstrong We can now envision the oasis that Ionis Pharmaceuticals saw with its hereditary angioedema data. Earlier this year, the company announced that donidalorsen had met the primary endpoint of a phase 3 study, but now we know it’s because the treatment spurred an 81% lower monthly rate of swelling attacks in patients who received the drug every four weeks. |
By Annalee Armstrong Adaptimmune was facing a financing cliff until Galapagos walked in with a sprawling licensing deal for a next-generation T-cell therapy that could total $665 million in biobucks. |
By Kevin Dunleavy A highly anticipated decision on Sanofi and Regeneron’s Dupixent to become the first biologic to treat chronic obstructive pulmonary disorder (COPD) is on hold in the United States but is speeding along in Europe. In the U.S., the FDA has pushed its decision date back three months to Sept. 27. Meanwhile in Europe, the Committee for Medicinal Products for Human Use (CHMP) has recommended Dupixent for approval to treat the disease. |
Fierce podcastsDon’t miss an episode |
| | This week on "Podnosis," Emma Beavins from Fierce Healthcare interviews CVS Health Chief Medical Officer Sree Chaguturu, M.D., to dive into the topic of telehealth and its role in a comprehensive approach to healthcare. |
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Fina Biosolutions has a clear mission: Make conjugate vaccines more affordable. FinaBio is unique in that it is a privately held, self-funded biotechnology company. The company needed to implement key strategies and solutions for cGMP manufacturing of EcoCRM®, FinaBio’s CRM197. Download to learn more!
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| WhitepaperPrecision collection of cell therapy source material doesn’t happen by chance. Our new whitepaper illuminates the science and strategies for successful apheresis. Sponsored by: Comprehensive Cell Solutions |
| WhitepaperLearn how Specifica’s in vitro antibody discovery platform can deliver better antibodies than traditional immunization approaches. Sponsored by: Specifica, a Q2 Solutions company |
| WhitepaperThis paper defines “digital companions” in biopharma, explores their value from the patient & company perspectives, & outlines a process for successfully fielding a new digital companion. Presented by: Blue Matter, strategic consultants in the life sciences |
| eBookTo make every rare disease trial count, we design patient-centric, relevant strategies for sponsors and caregivers to produce impactful results every time. Sponsored by: Emmes Company |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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