| Today's Big NewsFeb 21, 2023 |
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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 Nick Paul Taylor Pfizer is ready to ram home its advantage in the respiratory syncytial virus maternal vaccine race. With onetime close rival GSK still stalled, the Big Pharma has put itself on course to receive a landmark approval by August and go on to challenge AstraZeneca and Sanofi’s long-acting antibody for the market. |
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By Fraiser Kansteiner One of Fierce Pharma’s top three most anticipated drug launches of 2023 was also one of the year’s most uncertain. But on Friday, Apellis Pharmaceuticals bucked the industry’s losing trend in geographic atrophy (GA), scoring a second commercial nod for its C3 inhibitor pegcetacoplan. |
By Angus Liu Years after cutting ties to its disgraced founder, Martin Shkreli, and after navigating a regulatory hiccup, Travere Therapeutics has won an FDA approval for a first-of-its-kind drug for a rare kidney disease. |
By Phil Taylor Thousands of studies are registered each year in the U.S. alone, so there is always a vast array of disappointing results to choose from as we compile our 10 top clinical trial flops. |
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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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By Eric Sagonowsky As the biopharma industry moves beyond its groundbreaking pandemic response, we're looking for leaders with ideas that'll shape the future of the industry. |
By Andrea Park Dentsply Sirona is gearing up for a major overhaul that the company says could save it more than $200 million per year once complete. |
By Kevin Dunleavy Initially hyped as a game-changing COVID-19 treatment, the shine was off Merck and Ridgeback’s oral antiviral Lagevrio even before it was authorized for use in the U.S. Nevertheless, the pill generated more than $6.6 billion in sales over its first five quarters on the market, despite mounting evidence of its limited effectiveness. Another bit of confirmation came on Tuesday when Merck reported that Lagevrio did not provide a “statistically significant reduction” in the risk of COVID-19 following household exposure to the virus. |
By Andrea Park After a tougher-than-expected start to its fiscal year, Medtronic is finally getting back on track. |
By James Waldron While hemophilia has soaked up clinical attention and investor dollars for decades, it’s come at the expense of a range of intriguingly named but less well-known blood clotting disorders. That’s where Hemab Therapeutics comes in. |
By Kevin Dunleavy Novartis has made more than $30 billion from sales of its multiple sclerosis therapy Gilenya. But lately the drug’s decline has brought headaches for the Swiss pharma giant. A series of patent defeats has led Novartis to a last ditch appeal with the Supreme Court. And now, the company lost a high-stakes arbitration case against Mitsubishi Chemical Group. |
Fierce podcastsDon't miss an episode |
| | This week on "The Top Line," we discuss the intense patent fight between Moderna and Pfizer-BioNTech around the mRNA technology used in their COVID-19 vaccines. We also talk about negotiating vaccine contracts via text messages, one of the biggest medtech deals of the year and other top headlines from this week. |
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Wednesday, March 29, 2023 | 2pm ET / 11 am PT Attendees will come away with a deeper understanding of how genetic counseling and genetic services workflows can help biopharma organizations more effectively identify patients that qualify for their clinical trials and/or commercial therapeutics, the value of customized genetic services workflows in optimizing clinical trial/sponsored testing program ROI, and more. Register now.
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| 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 |
| 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 |
| 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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