| Today's Big NewsFeb 23, 2023 |
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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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| By Annalee Armstrong Novartis will no longer develop an ex vivo sickle cell disease program that was part of an older deal with Intellia, and the gene editing biotech’s CEO John Leonard thinks he knows why. |
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By Angus Liu Despite new phase 3 data for Eisai's Leqembi, the Centers for Medicare & Medicaid Services doesn't think there is enough evidence to reconsider a restrictive coverage policy for anti-amyloid Alzheimer's drugs. |
By Andrea Park For much of the last decade, rumors swirling around Silicon Valley have suggested that Apple is aiming to one day bring completely noninvasive glucose tracking to its eponymous smartwatch. |
By Max Bayer Moderna spent much of its fourth-quarter earnings call reassuring investors that its flu vaccine is still on an approval pathway after lukewarm phase 3 data dinged the company’s hot streak. |
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Tuesday, March 21, 2023 | 11am ET / 8am PT Today’s clinical trials are longer and more complex than ever. Sponsors, sites, and patients need technology that is practical, easy to use, and strengthens studies’ scientific integrity. This webinar will explore how approaches from B2B and consumer technologies can be leveraged to streamline processes, deliver quality outcomes data, and more. Register now. 
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By Kevin Dunleavy Sen. Elizabeth Warren has sent a letter to the U.S. Patent and Trademark Office asking for intense scrutiny of Merck's attempts to extend its patent protection for oncology superstar Keytruda. |
By Andrea Park Nearly a year after recalling a crucial component of its Harmony transcatheter pulmonary valve system—a process that began barely a year into the device’s initial rollout—Medtronic is once again striking the right note. |
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. |
By Zoey Becker It's back to the courts for Hikma Pharmaceuticals and Amarin. After battling over patents on Amarin's Vascepa, Hikma accuses Amarin of locking down exclusive ingredient contracts that prevented generics from entering the market. |
By Gabrielle Masson Just a few months after discontinuing its most advanced pipeline asset, BioCryst Pharmaceuticals is now delaying testing of its only remaining clinical candidate. |
By Angus Liu Roche is sending Gavreto back to Blueprint Medicines two and half years after the Swiss pharma paid $775 million upfront to in-license the RET inhibitor. |
Fierce podcasts Don'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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Wednesday, March 29, 2023 | 2pm ET / 11 am PT Attendees will come away with a deeper understanding of how genetic counseling and genetic services workflows can help biopharma organizations more effectively identify patients that qualify for their clinical trials and/or commercial therapeutics, the value of customized genetic services workflows in optimizing clinical trial/sponsored testing program ROI, and more. Register now. 
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Research Like 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 |
Whitepaper This paper explores the cost drivers behind gene therapies and how they are likely to evolve in the coming years. Sponsored by: Blue Matter |
Whitepaper Exploring the biology of G Protein-Coupled Receptors (GPCRs) and outlining a novel approach for developing therapeutics against previously undruggable GPCRs Sponsored by: Orion Biotechnology |
Whitepaper Learn 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 |
Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
Whitepaper Explore 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 |
Whitepaper Discover 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 |
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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