| Today's Big NewsMar 14, 2023 |
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April 3 - 4, 2023 | San Diego, CA This event will focus on how to wear multiple hats in a communications role and how to work with stakeholders to succeed. Register Today!
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| By James Waldron The latest fear stalking biotech boardrooms isn’t a trial fail or an underwhelming funding haul, it’s the postman delivering a letter from Nasdaq warning that the company’s stock faces being delisted from the stock exchange. |
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By Nick Paul Taylor Servier’s $1.8 billion oncology bet has delivered a phase 3 win. Vorasidenib, a candidate covered by the French drugmaker’s buyout of Agios Pharmaceuticals' cancer unit, beat placebo on the primary endpoint at an interim analysis to bring forward Servier’s regulatory filing plans. |
By Max Bayer Synaffix and MacroGenics are expanding their existing ADC-focused collaboration, upping the deal by $2.2 billion and putting four more targets on the table. The move comes as interest in ADCs grows at a rapid pace. |
Sponsored by Thermo Fisher Scientific In the development of mRNA vaccines and therapeutics, identifying a raw materials supplier who can partner with you from preclinical to commercial supply is a key to success. |
By Nick Paul Taylor Acesion Pharma has early clinical evidence that its new approach to treating atrial fibrillation works. In a phase 2 clinical trial, recipients of the biotech’s first-in-class ion channel inhibitor converted to sinus rhythm, boosting the prospects of a mechanism that could be the first new approach to afib in 20 years. |
By James Waldron A year and a half after its stem-cell-associated blood clot med was rejected by the FDA, Omeros is gearing up to head back to the regulator for another attempt. |
By Helen Floersh A new strategy from the lab of Carl June could overcome T-cell exhaustion and help make CAR-T and TCR-T therapies more effective against solid tumors. |
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 Joseph Keenan The U.K.’s National Health Service Blood and Transplant, which manages blood and platelet donations plus organ, stem cell and tissue transplants in the country, opened a new clinical biotech center to help boost the U.K.’s capacity to make DNA plasmids and viral vectors. |
By Andrea Park Illumina is reportedly the target of an upcoming proxy battle, stemming from the sequencing giant’s decision to plow ahead in its $8 billion re-acquisition of former spinout Grail in 2021 in defiance of regulators. |
By Nick Paul Taylor Chronic kidney disease (CKD) should be among the top health concerns of diabetes patients. Yet, while around 1 in 3 adults with diabetes has CKD, a Bayer survey of healthcare professionals shows that people are often unprepared for their diagnosis and that communication needs to improve. |
By Andrea Park Silicon Valley Bank's parent company SVB Financial Group is no longer eligible for inclusion on the S&P 500 and will therefore be removed from the index before the markets open on Wednesday—at which point Insulet will step in to take its place. |
By Heather Landi AUSTIN, Texas—Data privacy and access to online information about abortion care have become the next big battlegrounds in the fight over reproductive health in a post-Dobbs world. At SXSW 2023, privacy advocates outline the steps that digital health and health tech companies can and should be taking to better protect sensitive data. |
Fierce podcastsDon't miss an episode |
| This week on "The Top Line," we take on AI and machine learning in the pharma and healthcare universe. The expectation is that these tools will speed up innovation and open up new markets, helping the sector stay ahead of the curve. Plus, this week's headlines. |
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May 1 - 3, 2023 | Jersey City, NJ Connect with senior executives in Medical Affairs, MSL and IIT to share best practices. Save $200 when you register today!
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Whitepaper Preparation of critical process liquids and buffer components shifts resources away from core activities and can be filled with inefficiencies and risks that can increase time and costs across your workflow. Learn about the framework to help reduce your total costs beyond capital and operational expenditures and set a solid foundation for successful scale-up of buffer preparation. Sponsored by: Thermo Scientific Production Chemicals and Services |
Executive SummaryRead about the latest survey results from over 200 biopharma executives and the changing approaches to building biologic drug development pipelines. Sponsored by: Twist Bioscience |
WhitepaperHave you had your questions about mRNA/saRNA manufacturing unanswered during a webinar; have no fear, we have you covered here. Sponsored by: Aldevron |
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 |
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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