| Today's Big NewsMar 3, 2023 |
| By Kevin Dunleavy In slashing the cost of its insulin earlier this week by some 70%, Eli Lilly responded quickly to President Joe Biden’s State of the Union appeal to producers of diabetes medicines. But Lilly’s initiative wasn’t enough for relentless pharma industry adversary Sen. Bernie Sanders. In separate letters to the world’s other two premier manufacturers of insulin, Sanofi and Novo Nordisk, Sanders has asked them to also reduce the “outrageous” price of insulin in the United States. |
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By James Waldron Anyone looking for a roadmap out of the biotech bear market will take little comfort from Evaluate Vantage’s latest report. While Big Pharma valuations “regained their mojo” towards the end of last year, the outlook remains bleak for smaller-scaled drug developers. |
By Andrea Park CZ Biohub Chicago will focus specifically on developing new technologies equipped with sensors and probes that can draw out high-resolution biological information from human tissue at a molecular level. |
By Max Bayer Veru won't be receiving a EUA for its COVID treatment after all, the latest in a list of companies that missed the boat of softer regulatory waters. The company says that the FDA recommended that the company conduct a confirmatory trial, instead. |
By Zoey Becker It's been three years since the FDA rejected BioMarin's Roctivian, but the company hasn't given up. After scoring a European nod last summer, BioMarin is marching toward a March 31 FDA decision date for its hemophilia A gene therapy. |
By Nick Paul Taylor Praxis Precision Medicines isn’t letting a midphase fail stand in the way of its plans in essential tremor. While its selective T-type calcium channel blocker failed to beat placebo on the primary endpoint, Praxis zeroed in on secondary measures and post hoc analyses to make the case for further development. |
By Andrea Park Viz.ai is already an old hand at putting its disease-spotting artificial intelligence algorithms through the FDA review process, having secured the agency’s sign-off for seven of the AI tools to date. But for its next piece of software, the company is bringing in some extra help. |
By Angus Liu Roche and Exelixis’ combination of Tecentriq and Cabometyx has failed a third time. But to one analyst, the trial flop has a different significance for each drug. |
By Helen Floersh A TPD-based small molecule improved cognition and lowered pathological proteins and inflammatory cytokines in mice with Alzheimer's, suggesting the strategy might be worth pursuing. |
By Teresa Carey 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. |
Fierce podcasts Don'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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Tuesday, March 14, 2023 | 2pm ET / 11am PT Join this webinar to 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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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 |
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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 |
Whitepaper For 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 |
Whitepaper Learn 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 |
Whitepaper How 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 |
Whitepaper Planning 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 |
Whitepaper Explore 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 |
| May 1-3, 2023 | Jersey City, NJ |
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