| Editor’s Note: Fierce Biotech will not publish Monday, Feb. 20 in observance of Presidents' Day. We’ll be back in your inboxes Tuesday, Feb. 21 |
Today's Big NewsFeb 17, 2023 |
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As the #1 Bioscience Manufacturing Hub in the USA, Puerto Rico is the ideal location to reshore your operations. Benefit from operational stability, world-class talent, & unmatched incentives. Learn more.
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| By Eric Sagonowsky Gilead on Friday said Shaw will be leaving as Kite Pharma's CEO at the end of March. The company didn't give a reason for her departure, but the drugmaker said she'll work closely with Gilead CEO Daniel O'Day on the transition in the coming weeks. |
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By Nick Paul Taylor Pfizer and Valneva’s phase 3 Lyme disease vaccine clinical trial has gone badly wrong. After discovering good clinical practice violations at some trial sites, the partners have removed around half of the enrolled participants from the study. |
By Andrea Park Philips has identified two potential issues in some ventilators that were newly refurbished as result of the June 2021 recall of 5.5 million of the company's respiratory devices. |
By James Waldron Rather than racing to get an “off-the-shelf” CAR-T into the clinic or going all-in on a solid tumor strategy, GSK executives told Fierce Biotech they believe the Big Pharma's genetics expertise will offer the smoothest path to market success. |
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GPCRs are widely recognized as premier drug targets, but over 80% of these receptors remain undrugged. This whitepaper outlines a novel solution to revolutionize GPCR drug discovery. Learn more.
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By Kevin Dunleavy In 2020, when Novartis and Roche were fined 444 million euros ($475 million) by France’s Autorite de la Concurrence, it was the largest ever penalty levied by the country’s anti-competition watchdog. Three years later, the Swiss pharma giants are off the hook. |
By Fraiser Kansteiner Merck has reached a deal with real estate business Onyx Equities to sell its 108-acre campus in Kenilworth, NJ, where the drug behemoth relocated its main digs back in 2015. Merck will move out of Kenilworth in phases over the next “several years” as it completes an expansion at its new headquarters in Rahway, NJ. |
By Andrea Park A vulnerability found in software used to monitor some of BD’s infusion pumps could potentially give hackers access to personal data stored in the system. |
By Annalee Armstrong Moderna checked off two influenza A strains in a phase 3 clinical trial for a new flu shot candidate, but the vaccine struggled against two B strains in the same test, marking a mixed readout for the famed mRNA biotech. |
By Angus Liu Merck & Co.’s Keytruda has risen from the ashes with a positive stomach cancer trial readout. But there’s some reconciliation to do with a past failure that led to the withdrawal of an accelerated approval. |
By Andrea Park In a full-year earnings report published Thursday, Labcorp reported a 7.7% year-over-year drop in revenues in 2022, thanks almost entirely to a COVID diagnostics haul that weighed in at less than half the size of the previous year’s. |
By Kevin Dunleavy Madrigal’s resmetirom fared better than Intercept’s Ocaliva in a study by ICER assessing cost-effectiveness in non-alcoholic steatohepatitis (NASH). There are no approved treatments for the disorder which affects between 1.5% and 6.5% of adults in the United States. |
Fierce podcastsDon't miss an episode |
| This week on "The Top Line," we discuss the intense patent fight between Moderna and Pfizer-BioNTech around the mRNA technology used in their COVID-19 vaccines. We also talk about negotiating vaccine contracts via text messages, one of the biggest medtech deals of the year and other top headlines from this week. |
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Tuesday, March 14, 2023 | 2pm ET / 11am PT Join this webinarto hear industry experts across the clinical research space share their perspectives on inefficiencies in the current clinical research space, how to prioritize change, where to begin, how to measure success, and considerations when evaluating and selecting enabling technology. Register now.
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| 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 |
| WhitepaperExploring the biology of G Protein-Coupled Receptors (GPCRs) and outlining a novel approach for developing therapeutics against previously undruggable GPCRs Sponsored by: Orion Biotechnology |
| WhitepaperLearn more about critical success factors for your next launch based on the experience of 100+ pharma product launches. Sponsored by: Herspiegel Consulting |
| Whitepaper What makes nucleotides suitable for current good manufacturing practices? Sponsored by: Thermo Fisher Scientific |
| 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 |
| 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 |
| 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 |
| 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 |
| WhitepaperDiscover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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