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May 1 - 3, 2023 | Jersey City, NJ Don’t miss the opportunity to gain best practices in medical affairs strategy development and ensuring scientific materials are created and shared in a regulatory compliant manner to internal/external stakeholders and thought leaders. Take advantage of the Early Bird Rates, Register Today!
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Today's Big NewsFeb 7, 2023 |
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Tuesday, February 28, 2023 | 11am ET / 8am PT The heavy lifting for the pharmaceutical industry to comply with the November 2023 DSCSA go-live date is still ongoing. One item now finalized is to ensure that the required data exchange through the supply chain is only done with trusted, authorized, and registered trading partners. Join us for this discussion to stay up-to-date on this important legislation and be prepared for compliance. Register now.
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| By Annalee Armstrong Johnson & Johnson has yet to publicly detail the R&D overhaul reported last week by Fierce Pharma, and apparently at least one company with work that may be deprioritized or reorganized is waiting in the lurch. |
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By Angus Liu ICER President Steve Pearson, M.D., has put differentiating between gene therapy values on the group's to-do list. He also wants to update the cost watchdog's models after the passage of the Inflation Reduction Act. |
By Andrea Park Just over a year after being recognized by the FDA for the potential “breakthrough” nature of its radiation therapy, RefleXion has gotten the go-ahead from the agency to begin rolling out the system across the U.S. |
By Zoey Becker As biosimilars come for Humira, AbbVie is ready to pull out all the stops. The pharma giant will no longer be limiting itself to $2 billion a year on M&A, according to a Wall Street Journal interview with CEO Richard Gonzalez. |
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Evidation and Fierce Biotech conducted a survey of industry professionals to gather insights on the role integrated evidence strategies play in their businesses, as well as the impact of these strategies in helping to deliver better health outcomes. Access the findings from this important survey now.
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By Conor Hale As an independent spinout, Kandu Health will focus on assisting patients through recovery, with remote clinical navigators and support groups in addition to app-based education. |
By Gabrielle Masson Five years after the formation of the FDA’s Oncology Center of Excellence, the federal center slowed the launch of new projects to focus on existing programs, with particular focus on ramping up four programs to help modernize clinical cancer trials. |
By Fraiser Kansteiner A coalition of cystic fibrosis patients and their families petitioned governments in South Africa, Brazil, India and Ukraine to either revoke or suspend Vertex patents surrounding the company’s tripartite drug Trikafta. |
By James Waldron Life sciences investment firm Syncona has blamed a “disappointing” drop in returns on plummeting share prices for British biotechs across its portfolio in December. |
By Andrea Park 3M has developed a new medical product with major staying power. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we discuss what we can expect from the obesity market in 2023. We also recap the drugs approved last year. |
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The global demand for biologics is projected to increase considerably by 2030, but the challenges, risks, and costs are also growing. For pharma companies looking to bring a new biologic to market, meeting clinical trial milestones can be difficult. To access important insights, download this executive summary now.
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Whitepaper Discover the Power of Small with NanoplasmidTM – the next-generation plasmid for manufacturing today’s cell and gene therapies. Sponsored by: Aldevron |
Whitepaper This paper explores the cost drivers behind gene therapies and how they are likely to evolve in the coming years. Sponsored by: Blue Matter |
Whitepaper Exploring the biology of G Protein-Coupled Receptors (GPCRs) and outlining a novel approach for developing therapeutics against previously undruggable GPCRs Sponsored by: Orion Biotechnology |
Whitepaper Learn more about critical success factors for your next launch based on the experience of 100+ pharma product launches. Sponsored by: Herspiegel Consulting |
Whitepaper RCTs with digital twins require fewer control patients and shorten trial timelines for Alzheimer's disease. Sponsored by: Unlearn AI |
Whitepaper What makes nucleotides suitable for current good manufacturing practices? Sponsored by: Thermo Fisher Scientific |
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 Download this paper to learn considerations on how to move a biologic through clinical trials faster, advantages of Parallel Processing, and more. Sponsored by: Catalent |
Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? 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 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 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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