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With three foreign trade zones, including the largest non-contiguous zone in the U.S., bioscience firms in Puerto Rico profit from affordable international trade. It's not what's next, it's where. Puerto Rico. .png)
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Today’s Big NewsMay 8, 2024 |
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Tuesday, May 14, 2024 | 9:30am ET / 6:30am PT This webinar dives into patient-derived organoids viewed as the gold standard in bridging the gap between the lab and the clinic. The oncology portfolio allows researchers to incorporate patient relevance at every stage of the drug development pipeline - from target discovery and hit identification to lead validation and optimization. Register now. 
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| By Max Bayer Sanofi CSO Frank Nestle is leaving the company, a spokesperson confirmed. He joined the French pharma in 2016. |
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By Annalee Armstrong After Orchard Therapeutics’ gene therapy for a rare genetic disease was approved in March, Peter Marks, M.D., Ph.D., received a simple email from Commissioner Robert Califf, M.D. |
By Kevin Dunleavy Following the lead of French pharmaceutical giant Sanofi, Pfizer has agreed to settle more than 10,000 personal-injury claims from users of heartburn drug Zantac, resolving litigation in several U.S. state courts, according to Bloomberg. |
By Gabrielle Masson A young boy with Duchenne muscular dystrophy participating in Pfizer’s phase 2 gene therapy trial has died, the pharma shared in a May 7 letter cited by nonprofit Parent Project Muscular Dystrophy. |
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Tuesday, May 16, 2024 | 10 ET / 7am PT Clinical trials are shifting towards sustainability and efficiency, necessitating industry leaders to embrace innovative provisioned device solutions. This webinar reveals new approaches reshaping the clinical trial supply chain to mitigate carbon footprints and revolutionize device lifecycle management. Explore how proactive sustainability in device management can differentiate leading companies in life sciences innovation. 
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By Annalee Armstrong Accelerated approval—controversial, yes—but absolutely necessary for small, pre-revenue biotechs trying to find new treatments for small patient populations, the FDA’s Peter Marks, M.D., Ph.D., said Wednesday. |
By Fraiser Kansteiner While CEO Richard Francis caveated that Teva still has a “long way to go,” he figures the company has shown it can execute on its "Pivot to Growth" transformation strategy “very well,” and is “consistently doing so quarter on quarter.” |
By Andrea Park In an ongoing battle for dominance in the eyes of healthcare professionals for their work developing heart-disease-focused drugs, Novartis has now snatched the top spot from Pfizer, according to a recent report from ZoomRx. |
By Heather Landi Masimo secured FDA clearance for its OTC Stork baby monitoring system that can help track certain vital signs in healthy infants up to 18 months old and provide alarms to parents or caregivers. |
By Annalee Armstrong If your child is in a clinical trial for what could be a groundbreaking treatment to restore hearing, as a parent, you’re going to notice the changes before a clinical investigator ever does. That’s what happened for patient 1 in a phase 1/2 trial called CHORD. |
By Angus Liu Apellis’ geographic atrophy drug Syfovre delivered what CEO Cedric Francois called “robust” growth in the first quarter, as its sales topped analysts’ expectations. But investors still dragged the company’s shares down by 10% on Tuesday. |
By Conor Hale The company says the new version of its heart-mapping system marks its first to employ machine learning capabilities. |
By Andrea Park After making a corporate commitment late last year to advocate for family caregivers, Otsuka America Pharmaceutical is making good on that promise. |
By Max Bayer Walking Fish Therapeutics has closed after failing to secure additional funding, CEO Rusty Williams confirmed. The company was working on engineered B-cells to treat rare diseases. |
By Zoey Becker The companies second go at a long-acting schizophrenia med uses popular antipsychotic olanzapine, which Eli Lilly first marketed in the 90s but found safety issues with its own long-acting version. |
Fierce podcasts Don’t miss an episode |
| This week on "The Top Line," we're diving into the details of the spree of big-money biopharma deals in 2023 and examining what that means for this year. |
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Wednesday, May 22, 2024 | 11am ET / 8 am PT Learn GMP regulations in pharmaceutical storage at our upcoming webinar. Discover FDA requirements, including space validation, environmental controls, and risk mitigation. Explore services like aliquoting and cold chain transportation. Register now. 
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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 |
Whitepaper Explore the complex considerations of vaccine development for influenza and COVID-19, including the challenges posed by viral evolution and the importance of ongoing research in this paper by vaccine expert, Dr. Lisa Kierstead. Sponsored by: PPD®️ Laboratory Services |
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 |
Whitepaper Discover the secrets behind successful patient engagement Sponsored by: ProofPilot |
Whitepaper Antibody biomarkers are redefining precision medicine, from diagnosing diseases earlier to stratifying patients – download your FREE white paper today! Sponsored by: Sengenics Corporation LLC |
Whitepaper The use of prefilled syringes to administer biotherapeutics is beginning to gain traction because they offer a range of stability, efficacy, and patient safety benefits. Download this white paper to learn how Lonza has developed a novel workflow to ensure confidence regarding functionality in PFS and autoinjectors. Presented by Lonza |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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