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In 505(b)(2) development, programs are often derailed when sponsors lack experience with the specific processes and requirements of the approval pathway. These mistakes can lead to unnecessary trials being conducted, clinical holds, or the needless discontinuation of development. Download our guide to learn how to rectify past missteps and avoid future ones in 505(b)(2) product development. Premier Consulting. Built for Biotech℠. 
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Today's Big NewsJan 20, 2023 |
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Tuesday, January 24, 2023 | 11am ET / 8am PT Your CRO is a finalist in a project bid and clinical supplies are one of the aspects that you will manage on behalf of the client via a partner. Register now. 
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| By Annalee Armstrong Eli Lilly’s bid for an accelerated approval of Alzheimer’s disease drug donanemab has been shut down by the FDA. |
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By James Waldron Back in the summer, Cyteir Therapeutics announced that it was pressing pause on plans to get one of its cancer meds into the clinic. But it’s only now that we’re seeing the fallout of the decision to focus on its lead ovarian cancer asset—in the form of laying off 70% of its workforce. |
By Nick Paul Taylor The FDA has handed a boost to Astellas Pharma’s stuttering push into gene therapy by lifting the clinical hold on a phase 1/2 study in late-onset Pompe disease. Astellas was forced to pump the brakes on the AT845 program last year after a participant developed peripheral sensory neuropathy. |
Sponsored by Evidation Health Traditional real-world data isn’t truly from the real world – it’s from the clinical world, and it’s missing a big part of neuro patients’ stories. |
By Helen Floersh Surgically removing a tumor can cure a patient, but if there are any cancerous cells left around the edges, it’s likely to return. Applying a gel containing CAR-T cells to the surgical wound could clear out residual cancer and prevent recurrence, a new mouse study found. |
By Nick Paul Taylor Physicians lack a FDA-approved way to limit oral mucositis in head and neck cancer patients. EpicentRx wants to change that—and has shared a closer look at the phase 2 data that persuaded it to take the program deeper into the clinic. |
By James Waldron Less than a month after finally going public, Disc Medicine has come a step closer to getting a third blood disorder candidate into the clinic via a licensing deal with Mabwell worth $10 million upfront. |
By Annalee Armstrong We had hoped that our Layoff Tracker would stay retired for a while, but 2023 is starting to look a lot like our old friend 2022 when it comes to layoffs in biotech. |
By Andrea Park After blowing past the $1 billion mark in its lifetime funding tally with back-to-back chart-topping funding rounds in 2020 and 2021, Caris Life Sciences took a breather in 2022—but break time is over for the liquid biopsy maker. |
By Eric Sagonowsky After welcoming a new CEO and entertaining a potential buyout last year, West Coast cancer specialist Seagen is again adding to its trophy case of regulatory wins. The FDA granted accelerated approval to Tukysa as a second-line treatment for a specific type of colorectal cancer. |
By Max Bayer,Gabrielle Masson David Kessler, M.D., is resigning as chief scientific officer of the Biden administration’s COVID response, marking the end of Operation Warp Speed, the famed federal effort to develop and administer COVID vaccines. |
By Querida Anderson This week on "The Top Line," we take you inside Fierce's JPM Week event. Listen in on snippets from a lively panel discussion on how companies will navigate the drug pricing policies the Biden administration rolled out just last year. And hear from Christine Roth, head of Bayer's oncology strategic business unit, about the company's plans to become a strong competitor in cancer. |
By Angus Liu China has updated its state-covered drugs list after a round of steep price cuts. Sun Pharma has shelled out $576 million to acquire an alopecia drug developer. CDMO giant GenScript has raised $224 million for its biologics subsidiary. And more. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we take you inside Fierce's JPM Week event. Listen in on snippets from a lively panel discussion on how companies will navigate the drug pricing policies the Biden administration rolled out just last year. And hear from Christine Roth, head of Bayer's oncology strategic business unit, about the company's plans to become a strong competitor in cancer. |
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Tuesday, January 31, 2023 | 11:00am ET This Webinar will highlight the comprehensive set of tools that Aldevron developed to support advancing mRNA projects to clinic. In addition, an overview of the technology transfer program, analytical and process characterization, release, and stability will be discussed with an insight into Aldevron’s integrated CMC capabilities ranging from transcript design and product profile definition through encapsulation and fill/finish. Register now. 
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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 |
Whitepaper This paper explores how Medical Affairs is adapting medical communications to meet the demands of a new environment (part 5 in a series). Sponsored by: Blue Matter, strategic consultants in the life sciences |
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 |
Executive Summary Readers will learn manufacturing by Design Builds on Quality by Design, De-risking the Tech Transfer Process, and more. Sponsored by: Catalent |
Whitepaper How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent |
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 |
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 |
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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