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Shorten the amount of time spent figuring out which healthcare providers can receive controlled and non-controlled samples. OneKey Professional Sample Eligibility provides an HCP-specific eligibility indicator including best location for delivery. Learn more.
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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 Max Bayer FDA advisers endorsed the safety and efficacy of GSK's respiratory syncytial virus vaccine in older adults. But advisers expressed concerns with some safety signals and the lack of long-term data. |
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By Zoey Becker It's the end of a rocky road for Akorn. After years of financial problems, the drugmaker has laid off all of its employees, according to reports. |
By Fraiser Kansteiner Though safety signals and study design vexed FDA expert advisers, Pfizer’s vaccine candidate for respiratory syncytial virus (RSV), Abrysvo, ultimately won over the group. The question of the day? Whether the safety and efficacy of the shot merits an approval to prevent lower respiratory tract disease caused by RSV in older adults. |
By Annalee Armstrong Thirty years ago, the Down syndrome community helped scientists uncover critical learnings about the genetic basis of Alzheimer’s disease. Now in 2023, these patients still don't have access to emerging treatments. |
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Mar 14, 2023 12:00pm ET Health equity requires every moving piece of the healthcare ecosystem, including pharma companies. But ensuring a more equitable and an accessible healthcare system starts for pharma at the beginning. It starts with the HCPs you engage for pre-drug launch and marketing; it starts with the site investigators you recruit; it starts with the location and availability of the study. Register now to learn more.
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By Eric Sagonowsky Moderna and the U.S. government are putting one patent dispute to bed. Under a licensing deal inked late last year, the mRNA specialist recently paid a $400 million "catch-up payment." |
By Andrea Park For much of the last decade, rumors swirling around Silicon Valley have suggested that Apple is aiming to one day bring completely noninvasive glucose tracking to its eponymous smartwatch. |
By Kevin Dunleavy A potential buyout of Seagen by Pfizer—which was reported Sunday by The Wall Street Journal—makes “strategic sense for both parties and the antitrust hurdle appears surmountable,” Berenberg Capital Markets wrote in a note to investors. |
By Teresa Carey 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. |
By Ben Adams Bristol Myers Squibb, Boehringer Ingelheim and Roche are the most mature pharmas on social media, though there are still areas in which the companies can do better. |
By James Waldron With over 10 indications already being explored and the promise of more to come, it’s no surprise that Johnson & Johnson’s nipocalimab has been dubbed a “pipeline in a product.” It's a good thing, too, because the monoclonal antibody didn't come cheap. |
By Zoey Becker Sanofi and partner Sobi are coming back to the hemophilia A market with a vengeance after Roche’s Hemlibra ate up sales of their aging Eloctate. The duo expects the once-weekly Altuviiio to be commercially available in April. |
By Max Bayer Billy Dunn is leaving his post leading the FDA’s neuroscience team, leaving behind an 18-year legacy that in recent years has included the controversial accelerated approval of Biogen’s Alzheimer’s med, Aduhelm. |
By Angus Liu Novartis has been experiencing challenges meeting the demand for Pluvicto. And as demand climbs, the company has decided to pause accepting new patients until it has “more clarity on the FDA’s approval” of a manufacturing site in New Jersey. |
By Andrea Park Nearly two years after submitting its MiniMed 780G insulin delivery system to the FDA for clearance, Medtronic is still awaiting the agency’s nod—though not for a lack of evidence to back the technology. |
By Annalee Armstrong Both Pfizer and GSK’s upcoming respiratory syncytial virus vaccines had instances of Guillain-Barré syndrome in clinical trials. And yet the FDA is only recommending that one of them conduct a new post-marketing study to assess the risk. |
By Gabrielle Masson The FDA won’t be holding an advisory panel meeting for Sarepta Therapeutics’ SRP-9001, which is now that much closer to becoming the first gene therapy for Duchenne muscular dystrophy. |
By Joseph Keenan Health tech firm Clario is linking with tech start-up ArtiQ with the aim of leveraging AI for improved patient benefits and solidifying the certainty of data collection in respiratory trials that require spirometry data. |
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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Monday, March 20, 2023 | 2pm ET / 11am PT In this webinar we will discuss balancing cost considerations with other factors of importance including production volume, dosage form, regulatory considerations, the geography in which the product will launch, dual sourcing to mitigate risk, building robust supply chains with the capacity to handle disruption, supplier qualification, and more. Register now.
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| WhitepaperHave you had your questions about mRNA/saRNA manufacturing unanswered during a webinar; have no fear, we have you covered here. Sponsored by: Aldevron |
| WhitepaperThis paper describes the key elements of good US/EU corporate governance for US-based biopharma companies in operating Europe. Sponsored by: Blue Matter, strategic consultants in the life sciences |
| 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 |
| 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 |
| eBook Catalent’s Carla Vozone discusses the significant trends in the Orally Inhaled & Nasal Drug Delivery (OINDP) segment including large molecules and novel indications. Sponsored By: Catalent |
| 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 |
| 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 |
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