| Today's Big NewsFeb 16, 2023 |
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As the #1 Bioscience Manufacturing Hub in the USA, Puerto Rico is the ideal location to reshore your operations. Benefit from operational stability, world-class talent, & unmatched incentives. Learn more.
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| By Max Bayer GSK's head of vaccine R&D, Phil Dormitzer, is confident that the company has posted pack-leading data for its RSV vaccine, as it nears the finish line of the regulatory race. But he wouldn't commit to restarting trials testing the shot in maternal women after a phase 3 study was halted a year ago. |
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By Fraiser Kansteiner At a meeting of the agency’s Nonprescription Drugs and Anesthetic and Analgesic Drug Products advisory committees, the FDA’s panel of 19 independent experts voted unanimously in favor of an over-the-counter nod for Emergent BioSolutions’ opioid overdose reversal drug Narcan. |
By Andrea Park GE HealthCare has begun a recall of several models of its nuclear medicine imaging systems that were found to be at risk of collapsing while in use, potentially crushing or trapping a patient underneath. |
By Gabrielle Masson A biotech led by a 20-year Alnylam vet has emerged with $193 million in hand and hopes of unlocking genetic medicine’s fullest potential. |
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GPCRs are widely recognized as premier drug targets, but over 80% of these receptors remain undrugged. This whitepaper outlines a novel solution to revolutionize GPCR drug discovery. Learn more.
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By Andrea Park A year after Charles River Laboratories teamed up with artificial intelligence developer Valo Health to build an AI-powered drug discovery and development platform, the contract research organization is putting that tech to work. |
By Kevin Dunleavy In his first earnings presentation as new CEO of Seagen, David Epstein had lots of good news to share. And at least one analyst liked what he heard from the former Novartis oncology chief, saying the biotech’s “growth drivers are firing.” |
By Angus Liu Prostate cancer is giving Merck & Co.’s seemingly unstoppable Keytruda a hard time. But even after three pivotal trial flops in less than a year, clinical development lead Scot Ebbinghaus still thinks Merck made the right decision to go aggressive on its phase 3 program back in 2019. |
By Angus Liu Pfizer may be the last major oncology player to put a wager on a PARP inhibitor in prostate cancer, but the New York pharma appears to have a winning regimen, partly thanks to its Astellas-partnered stalwart Xtandi. |
By Andrea Park In its second such deal in as many days, Insulet has put down another $25 million to acquire technology used in automating insulin delivery. |
By Annalee Armstrong,Gabrielle Masson,Max Bayer We had hoped that our Layoff Tracker would stay retired for a while, but 2023 is starting to look a lot like our old friend 2022 when it comes to layoffs in biotech. |
Fierce podcastsDon't miss an episode |
| In this week's episode of "Podnosis," we talk about what can be done to reduce errors in health records. We also discuss what telemedicine companies—in particular telepsychiatry firms—will face with the looming end of the public health emergency. |
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Tuesday, March 14, 2023 | 2pm ET / 11am PT Join this webinarto hear industry experts across the clinical research space share their perspectives on inefficiencies in the current clinical research space, how to prioritize change, where to begin, how to measure success, and considerations when evaluating and selecting enabling technology. Register now.
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| Whitepaper Discover the Power of Small with NanoplasmidTM – the next-generation plasmid for manufacturing today’s cell and gene therapies. Sponsored by: Aldevron |
| WhitepaperThis paper explores the cost drivers behind gene therapies and how they are likely to evolve in the coming years. Sponsored by: Blue Matter |
| WhitepaperExploring the biology of G Protein-Coupled Receptors (GPCRs) and outlining a novel approach for developing therapeutics against previously undruggable GPCRs Sponsored by: Orion Biotechnology |
| WhitepaperLearn more about critical success factors for your next launch based on the experience of 100+ pharma product launches. Sponsored by: Herspiegel Consulting |
| WhitepaperRCTs with digital twins require fewer control patients and shorten trial timelines for Alzheimer's disease. Sponsored by: Unlearn AI |
| Whitepaper What makes nucleotides suitable for current good manufacturing practices? Sponsored by: Thermo Fisher Scientific |
| WhitepaperWhat are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
| WhitepaperExplore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
| Research Learn more on Catalent’s step-wise approach for the definition and execution of Process Characterization for the production of a monoclonal antibody for late phase process characterization and development. Sponsored by: Catalent |
| Case Study Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
| WhitepaperDiscover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
| Whitepaper As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs. Sponsored by: Catalent |
| Research Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
| WhitepaperFor sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management. Sponsored by: Catalent |
| WhitepaperLearn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region. Sponsored by: Catalent |
| WhitepaperHow can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis. Sponsored by: Catalent Clinical Supply |
| WhitepaperPlanning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial. Sponsored by: Catalent |
| WhitepaperExplore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world. Sponsored by: Catalent |
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