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Today's Big NewsMar 1, 2023 |
| 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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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 Max Bayer Chroma has tacked on another nine-digit fundraising round less than 18 months after unveiling with $125 million. The company has yet to unveil its pipeline but is touting preclinical data that will be unveiled throughout the year. |
Sponsored by North Carolina Biotechnology Center Growth in North Carolina’s life sciences has outpaced most U.S. life sciences hubs. Top talent, infrastructure, and business-friendly climate are why companies are choosing the Tar Heel state. |
By Annalee Armstrong Ambrx walked away from a breast cancer drug in October, citing the competitive pressure from AstraZeneca and Daiichi Sankyo’s blockbuster Enhertu. But new CEO Daniel O’Connor has spied an opportunity to get the drug back in the clinic. |
By Nick Paul Taylor Clinical data have convinced Atea Pharmaceuticals it cannot make the numbers add up in dengue. Based on the results, the antiviral biotech calculates it would take at least three years and cost several hundred million dollars to run phase 2 studies, prompting it to put the program on the back burner. |
By James Waldron PMW Pharmaceuticals has pressed pause on two preclinical tumor candidates to funnel all resources into getting its lead precision oncology med through the clinic. |
By Nick Paul Taylor Are antibody-drug conjugates the key to better gene editing treatments? That is a question posed by the latest deal by Vertex, which is paying ImmunoGen $15 million upfront to explore the use of ADCs with its near-approval CRISPR/Cas9 therapy exagamglogene autotemcel. |
By Helen Floersh Despite being an earlier disease stage, there’s relatively little focus on developing NAFLD treatments compared to NASH therapies, largely because there are no reliable models for understanding the condition. That could change with the first organoids for studying the condition. |
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 Kevin Dunleavy Five weeks into his job as the new CEO as Novavax, John Jacobs raised the possibility on Tuesday afternoon that the company may not survive 2023. “Uncertainty,” was used often during the company’s fourth quarter conference call, so much so that the company did not provide guidance on its expected revenue in 2023. |
By Andrea Park Amid Boston Scientific’s decision to transfer some work out of a facility in Houston in the coming months, more than 100 jobs are hanging in the balance. |
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 A wearable device from Theranica Bio-Electronics that was cleared by the FDA in 2019 to ease the symptoms of migraine may now take a much more proactive approach to that treatment. |
By Kevin Dunleavy The FDA has given Cytokinetics a thumbs down for omecamtiv mecarbil, a once-promising candidate for heart failure patients with reduced ejection fraction. The decision was not a surprise given that an FDA advisory committee voted 8-3 in December to recommend against approval. |
Fierce podcastsDon't miss an episode |
| | This week on "The Top Line," we discuss a checklist that the Society for Immunotherapy of Cancer released last October. The guidelines are designed to maximize the value of phase 3 immuno-oncology combination trials. We also cover the top headlines from this week. |
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| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| WhitepaperDiscover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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