| Today's Big NewsMar 8, 2023 |
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Production of these particles, which can protect and deliver medicines and vaccines where they need to go in the body, is increasing. Learn more about how collaborating with a CDMO could be invaluable in developing nano-based systems. Learn more.
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| By Nick Paul Taylor Merck & Co. has joined the emerging race to develop an Epstein-Barr virus vaccine, paying ModeX Therapeutics $50 million upfront and dangling $872.5 million in biobucks for global rights to a preclinical challenger to shots in clinical development at Moderna and the NIH. |
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By James Waldron Fresh Track’s atopic dermatitis treatment has strolled through a phase 1 study, but the company is considering anything from a licensing deal all the way through to a total sale in order to take the drug forward. |
By Nick Paul Taylor Redx has hit a thorny patch. In the first data from a phase 2 program, Redx’s porcupine inhibitor RXC004 failed to improve progression-free survival in biliary tract cancer (BTC), prompting the British biotech to stop monotherapy development and focus on combinations in the indication. |
Sponsored by Syneos Health This story centers on the benefits of implementing a full service commercial model to improve launch success for customers who lack the necessary infrastructure. Watch how Syneos Health expertise in Medical Affairs acted as a bridge to forge this full service commercial partnership, which helped meet critical deadlines for patients. |
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Thursday, March 23, 2023 | 10am ET / 7am PT In this webinar, we will discuss customer-centric digital innovations that are improving overall process, product quality and performance, as well as transforming CDMO relationships. Register now to learn more!
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By James Waldron If at first you don’t succeed, try, try again. That certainly seems to be Mesoblast’s motto—and it may pay off yet. |
By Max Bayer The FDA has cleared plans for Inhibikase's neurodegeneration asset to be trialed in patients with a rare brain disease. The news comes six weeks after U.S. regulators lifted a hold on the company's Parkinson's disease trial. |
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 Fraiser Kansteiner After handing Narasimhan $9 million in performance-based pay in 2021, Novartis' compensation committee slashed the CEO’s award in that category by a whopping 61% last year. The pay cut, spurred by turbulent performance between 2020 and 2022, contrasts sharply with Novartis’ execution during the first three-year stretch under Narasimhan’s lead. |
By Andrea Park Two years after Abbott landed FDA clearance for a hand-held blood test that could detect signs of mild traumatic brain injuries in the span of about 15 minutes, the concussion-spotting test is heading to the big leagues. |
By Angus Liu When Roche touted data for Polivy in previously untreated large B-cell lymphoma, the company billed the drug as the first potential new treatment standard in nearly two decades. But the FDA sees things differently. |
By Andrea Park The ReWalk personal exoskeleton is the first to be cleared in the U.S. to help partially paralyzed users surmount stairs and curbs. |
By Kevin Dunleavy Following a report last month that GSK kept quiet for more than four decades about the presence of a potential carcinogen in heartburn drug Zantac, Rep. Rosa DeLauro wants to know whether the FDA plans to investigate. |
By Robert King President Joe Biden proposed to raise taxes on wealthy Americans and expand the drugs eligible for Medicare price negotiation to shore up the Medicare trust fund. |
Fierce podcastsDon't miss an episode |
| | This week on "The Top Line," we discuss 2022's M&A trends in the medtech sector and the surprising multibillion-dollar megadeals. We also cover the top headlines from this week. |
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May 1-3, 2023 | Jersey City, NJ
Examine how the current changes to field medical will affect the role moving forward. Last chance to save on Early Bird Rates, Register Today!
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| 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 |
| 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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