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Thursday, March 23, 2023 | 10am ET / 7am PT In this webinar, we will discuss customer-centric digital innovations that are improving overall process, product quality and performance, as well as transforming CDMO relationships. Register now to learn more! .png)
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Today's Big NewsMar 7, 2023 |
| By Angus Liu Ongoing controversy around AbbVie’s patenting strategy for Humira didn’t stop CEO Rick Gonzalez from getting a pay bump in 2022. |
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By Gabrielle Masson,Max Bayer,Annalee Armstrong Alongside the new year, we've launched a new Fierce Biotech Fundraising Tracker to keep the pulse on the industry's financing. |
By Zoey Becker After a long road to the FDA finish line for BioMarin, the agency just moved the goal post back by a few months. The new decision date for hemophilia A gene therapy Roctavian is June 30 versus the previous date of March 31. |
By Andrea Park The FDA has yet to clear any PFA devices for use in the U.S., and Boston Scientific, Johnson & Johnson and Medtronic are among the medtech developers vying to snag the first nod—though the latter may have edged ahead with the publication of promising new study results this week. |
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Tuesday, March 14, 2023 | 2pm ET / 11am PT Join this webinar to 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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By Angus Liu When Roche touted data for Polivy in previously untreated large B-cell lymphoma, the company billed the drug as the first potential new treatment standard in nearly two decades. But the FDA sees things differently. |
By Nick Paul Taylor Immuneering is going all in on its universal-RAS candidate, leading it to suspend work on discovery-stage neuroscience programs and throw its resources behind an oncology program that is on course to deliver early clinical data in the coming months. |
By Andrea Park When it comes to Neuromod Devices’ neurostimulation system to relieve tinnitus, the FDA is all ears. |
By Annalee Armstrong A hero has arrived in Protagonist Therapeutics’ story, in the form of a Johnson & Johnson-partnered psoriasis med that has just cleared lesions in a mid-stage trial. |
By Andrea Park The ReWalk personal exoskeleton is the first to be cleared in the U.S. to help partially paralyzed users surmount stairs and curbs. |
By Helen Floersh Computers that run off human brain cells sound like something out of a science fiction novel—but for scientists working in the newly dubbed field of organoid intelligence, bringing together neurons and silicon offers enormous potential for understanding and treating brain disease. |
By Fraiser Kansteiner Sanofi is moving its flagship New Jersey site in Bridgewater roughly 15 miles northeast to Morristown—and all 1,900 employees are coming along for the ride, a company spokesperson confirmed. The site’s relocation marks the latest stop on a global campaign to modernize Sanofi’s workspaces, he said. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we discuss 2022's M&A trends in the medtech sector and the surprising multibillion-dollar megadeals. We also cover the top headlines from this week. |
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Tuesday, March 21, 2023 | 11am ET / 8am PT Today’s clinical trials are longer and more complex than ever. Sponsors, sites, and patients need technology that is practical, easy to use, and strengthens studies’ scientific integrity. This webinar will explore how approaches from B2B and consumer technologies can be leveraged to streamline processes, deliver quality outcomes data, and more. Register now. 
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Executive Summary Read about the latest survey results from over 200 biopharma executives and the changing approaches to building biologic drug development pipelines. Sponsored by: Twist Bioscience |
Whitepaper Have you had your questions about mRNA/saRNA manufacturing unanswered during a webinar; have no fear, we have you covered here. Sponsored by: Aldevron |
Whitepaper Download Herspiegel Consulting’s Go-To-Market Model, based on 100+ launches, to learn the critical components, and timelines for commercial success. Sponsored by: Herspiegel Consulting |
Research Like many top 10 and global pharma companies, an H1 client needed to diversify both its patient outreach and site investigator profiles for upcoming trials. Sponsored by: H1 |
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Whitepaper Learn more about critical success factors for your next launch based on the experience of 100+ pharma product launches. Sponsored by: Herspiegel Consulting |
On-Demand Webinar See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions. Sponsored by: Twist Bioscience |
Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
Whitepaper Explore 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 |
Whitepaper Discover 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 |
Whitepaper For 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 |
Whitepaper Learn 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 |
Whitepaper How 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 |
Whitepaper Planning 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 |
Whitepaper Explore 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 |
| May 1-3, 2023 | Jersey City, NJ |
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