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Today's Big NewsFeb 28, 2023 |
| By Annalee Armstrong Both Pfizer and GSK’s upcoming respiratory syncytial virus vaccines had instances of Guillain-Barré syndrome in clinical trials. And yet the FDA is only recommending that one of them conduct a new post-marketing study to assess the risk. |
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By Gabrielle Masson AstraZeneca is bucking the biopharma layoff trend, instead expanding its Canadian footprint with the creation of 500 new jobs and a new rare disease research hub. |
By Max Bayer Billy Dunn is leaving his post leading the FDA’s neuroscience team, leaving behind an 18-year legacy that in recent years has included the controversial accelerated approval of Biogen’s Alzheimer’s med, Aduhelm. |
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 James Waldron It’s an increasingly common story in 2023—a biotech searching for strategic options after a tough set of clinical data is snapped up by a private company that sees an opportunity in the clinical expertise and Nasdaq listing. |
By Nick Paul Taylor Serial clinical trial train wreck Aptinyx is at it again. After seeing a pain prospect flunk three clinical trials, the biotech has added Parkinson's disease and dementia to its list of failed indications—prompting it to stop work on its two clinical candidates, cut costs and seek strategic alternatives. |
By Nick Paul Taylor Junshi Biosciences has delivered the data to challenge Amgen and Sanofi for a cardiovascular disease opportunity, with the results of two phase 3 anti-PCSK9 antibody trials advancing the Chinese biotech toward approval in its home market. |
By Annalee Armstrong Theravance Biopharma has taken a series of body blows over the past few years, but executives think they’re on the right track—one that will be taken without 17% of staff and a JAK program that long ago lost its luster. |
By Helen Floersh The development marks the first time scientists have developed a product that integrate with living tissue to conduct electricity. |
By Kevin Dunleavy A potential buyout of Seagen by Pfizer—which was reported Sunday by The Wall Street Journal—makes “strategic sense for both parties and the antitrust hurdle appears surmountable,” Berenberg Capital Markets wrote in a note to investors. |
By Andrea Park Several years into the process of rectifying potential breaches in the sterile packaging of its life support systems—a process that has been littered with field correction notices and FDA-rated recalls—Getinge has been hit with a particularly serious penalty. |
By Kevin Dunleavy The U.S. Justice Department and the SEC have charged former Phlow Vice President Andrew Stiles with insider training, alleging that he and his cousin, Gray Stiles, netted more than $1.5 million on purchases of stock made using nonpublic information about a government pandemic preparedness contract awarded to Eastman Kodak. |
By Angus Liu The last of four pivotal trials Merck launched for Keytruda in prostate cancer has returned negative, ending a four-year expedition that endured repeated failures. And the PD-1 star also chalked up a failure in certain non-small cell lung cancer. |
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 Annalee Armstrong,Gabrielle Masson,Max Bayer 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. |
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 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 |
| WhitepaperThis paper explores the cost drivers behind gene therapies and how they are likely to evolve in the coming years. Sponsored by: Blue Matter |
| 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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