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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!
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Today's Big NewsMar 6, 2023 |
| By Zoey Becker After scoring an accelerated approval for Alzheimer's disease drug Leqembi in January, Eisai and Biogen hope to turn that into a traditional approval by July 6. But an advisory committee will get a chance to vote on the drug first. |
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By Max Bayer Merck & Co. has looked to its mid-to-late stage cardiovascular pipeline as a potential goldmine amid the race to replace Keytruda's revenue stream. And a handful of new readouts provide a glimpse into the promise the company is banking on. |
By Andrea Park As diabetes device makers race to build completely hands-off artificial pancreas systems, Abbott’s continuous glucose monitors are getting a significant upgrade. |
By Angus Liu Thanks to two FDA nods, Eli Lilly's Verzenio doesn't need results from a biomarker test to treat certain patients with early breast cancer, and it has followed Pfizer's Ibrance with an expanded use in the metastatic setting in women regardless of menopausal status. |
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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 Annalee Armstrong It’s been a year since Novartis ventured into orbit with Voyager Therapeutics to find new central nervous system targets. Now, the Big Pharma is ready to go deeper into space with the AAV capsid discovery biotech. |
By Andrea Park According to a study published last year, after an average of 16 sessions with Sooma Medical’s device, just over half of 410 participants saw their depressive symptoms reduced by at least 50%. |
By Nick Paul Taylor Incyte’s first bid to build a better Jakafi regimen is banjaxed. A phase 3 trial of parsaclisib and Jakafi has come screeching to a halt ahead of schedule after the independent data monitoring committee found it was on course to fail. |
By Kevin Dunleavy Johnson & Johnson's Opsynvi—which consists of 10 mg of Opsumit (macitentan) and 40 mg of Adcirca (tadalafil)—significantly improved blood flow versus macitentan or tadalafil as monotherapies for the treatment of patients with pulmonary arterial hypertension. |
By Kevin Dunleavy When added to aspirin, Bayer and Johnson & Johnson’s Xarelto reduced the risk of acute limb ischemia by 33% in patients with peripheral artery disease who had lower extremity revascularization surgery. Results from a prespecified analysis of a phase 3 study were presented at the American College of Cardiology’s 72nd Annual Scientific Session. |
By Andrea Park A surgical robot system developed by Noah Medical and newly cleared by the FDA is out of this world—or, at least, the current world of bronchoscopy procedures. |
By Annalee Armstrong Invivyd, which was launched in the early days of the pandemic under the name Adagio to find treatments for COVID-19, is hoping the third monoclonal antibody is the charm. |
Fierce podcastsDon'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 SummaryRead about the latest survey results from over 200 biopharma executives and the changing approaches to building biologic drug development pipelines. Sponsored by: Twist Bioscience |
| WhitepaperHave 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 |
| ResearchLike 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 |
| Whitepaper Discover the Power of Small with NanoplasmidTM – the next-generation plasmid for manufacturing today’s cell and gene therapies. Sponsored by: Aldevron |
| WhitepaperLearn 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 |
| 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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