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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 30, 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 In the years since gaining an initial FDA approval for Breyanzi, Bristol Myers Squibb has worked hard to expand the reach of its cell therapy. For the third time in as many months, those efforts have yielded a label expansion at the FDA. |
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By Annalee Armstrong A Special Report from the Fierce Biotech team on the state of cell therapy. |
By Helen Floersh,Annalee Armstrong Findings from a series of patient studies in Germany have sparked a frenzy of interest in CAR-T therapy for autoimmune disease, with companies like CRISPR Tx, Kyverna, Novartis and others investing in the approach. |
By Kevin Dunleavy With Verona Pharmaceuticals' COPD candidate ensifentrine approaching its FDA decision date, GlobalData has referred to it as a “paradigm shift in COPD treatment.” Additionally, ICER has estimated that ensifentrine would meet cost-effectiveness thresholds at an annual price between $7,500 and $12,700 per year. |
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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 James Waldron Ultragenyx is gearing up to take its glycogen storage disease (GSD) treatment to regulators next year after the gene therapy helped patients reduce their intake of cornstarch, which is currently used to treat the disease, in a phase 3 trial. |
By Conor Hale Virtual Therapeutics, the maker of virtual reality software for mental health and wellness, will pay about 43.4 cents per share. |
By Andrea Park Living with chronic myeloid leukemia can feel as if you’re lugging around a massive weight everywhere you go—and Novartis is hoping to give doctors a taste of that experience so they can better understand their patients’ burden. |
By Annalee Armstrong To speed up drug applications, the FDA has laid out new guidance on how to request a platform designation that can smooth subsequent applications for biotechs working off the same reproducible technology. |
By Conor Hale Dubbed HDx therapy, the company said its study reported a 25% reduction in all-cause mortality rates over a four-year period, compared to the more commonly used method of high-flux hemodialysis. |
By Fraiser Kansteiner Under an expansion of the partners’ existing deal, the Coalition for Epidemic Preparedness Innovations (CEPI) is committing up to $145 million to bolster BioNTech’s efforts to establish vaccine R&D and manufacturing capabilities at the German company’s facility in Kigali, Rwanda. |
By Andrea Park A year after Almirall shared survey results showing that a vast majority of people are unaware of actinic keratosis, the most common precursor of skin cancer, and bumped up its educational efforts, the Spanish pharma’s work is still far from done. |
By Kevin Dunleavy The U.S. government has expanded its avian flu pandemic preparedness partnership with CSL Seqirus. It is the fourth award from the Biomedical Advanced Research and Development Authority (BARDA) to the company and secures the delivery of 4.8 million doses that are matched to the current H5N1 strain of the virus. |
By James Waldron Soterios Pharma is eyeing phase 3 after a 1% dose of the company's alopecia areata cream improved severity of the condition, hitting the main goal of a mid-stage trial. |
By Zoey Becker The generic chemo is included in many standard-of-care treatment regimens and is one of many chemotherapies facing supply woes. |
Fierce podcasts Don’t miss an episode |
| This week’s episode of “The Top Line,” is the final part of a three-part series diving into the latest advancements in cell and gene therapy manufacturing. |
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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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Whitepaper Precision 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 |
Whitepaper Learn how Specifica’s in vitro antibody discovery platform can deliver better antibodies than traditional immunization approaches. Sponsored by: Specifica, a Q2 Solutions company |
Whitepaper This 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 |
eBook To 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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