| Today's Big NewsMar 9, 2023 |
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Production of these particles, which can protect and deliver medicines and vaccines where they need to go in the body, is increasing. Learn more about how collaborating with a CDMO could be invaluable in developing nano-based systems. Learn more. 
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| By Annalee Armstrong Vertex’s type 1 diabetes cell therapy turned heads when one patient's islet cell function was restored. Now, the pharma is readying version 2.0 for the clinic after the FDA cleared a similar treatment that uses a device to shield the cells from the body’s immune system. |
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By Nick Paul Taylor As the pile of failed Alzheimer’s disease programs grew ever larger, researchers identified trials in earlier- and earlier-stage patients as the key to efficacy. The flops were a case of right drug, wrong patients, the theory went. Eli Lilly put the idea to the test—and 10 years later has learned its drug was at fault all along. |
By Nick Paul Taylor The end is near for Neoleukin Therapeutics. Months after laying off 40% of its staff and dropping its lead candidate, the de novo protein specialist has revealed plans to part company with 70% of its remaining employees, including its CEO, and hunker down while it searches for a strategic alternative. |
Sponsored by Syneos Health This story centers on the benefits of implementing a full service commercial model to improve launch success for customers who lack the necessary infrastructure. Watch how Syneos Health expertise in Medical Affairs acted as a bridge to forge this full service commercial partnership, which helped meet critical deadlines for patients. |
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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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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 James Waldron The FDA’s ongoing clinical hold on Fulcrum’s sickle cell disease therapy was sparked by concerns about potential hematological malignancies, the biotech has revealed. |
By Helen Floersh Researchers have uncovered yet another potential treatment mechanism in the quest to find new therapies for Alzheimer’s disease, this time modifying mRNA to bring immune cells into the brain. |
By Joseph Keenan Adaptive Research, a CRO focused on putting community physicians into the clinical trial process, has partnered with AHMC Seton Medical Center to expand patient access to new drug studies. |
By Joseph Keenan Biotech Creative Medical Technology has tapped Syneos to run a phase 1/2 randomized trial of its cell therapy for the potential treatment of Type 1 diabetes. |
By Joseph Keenan Koneksa has linked with life sciences consultant SSI Strategy as part of the Novartis- and Merck-backed company’s strategy to expand digital biomarkers in clinical trials. |
By Fraiser Kansteiner Liquid albuterol—which is inhaled via nebulizer to increase air flow to the lungs—has been running scarce since autumn, according to the U.S. FDA. The regulator lists just two domestic suppliers for the drug: South Carolina’s Nephron Pharmaceuticals and the now-defunct Akorn. |
By Andrea Park Amid reports of layoffs within Johnson & Johnson's Janssen pharmaceutical division and outgoing consumer health group, the job cuts have now reached J&J’s medtech division. |
By Anastassia Gliadkovskaya The Walgreens decision stems from a letter written by nearly two dozen Republican state attorneys general at the beginning of February that threatened legal action if the company began distributing Mifepristone in their states. |
By Fraiser Kansteiner As Sanofi and Regeneron press their patent agenda at the U.S. Supreme Court, Amgen has accused its rivals of ignoring set legal standard. |
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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May 1-3, 2023 | Jersey City, NJ
Examine how the current changes to field medical will affect the role moving forward. Last chance to save on Early Bird Rates, Register Today! .png)
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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 |
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 |
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 |
Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? 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 |
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 |
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 |
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 Discover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. 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 |
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 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 |
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 |
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 |
| May 1-3, 2023 | Jersey City, NJ |
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