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Tuesday, December 5, 2023 | 1pm ET / 10am PT Join us to learn more about what impact deep engineering engagement and an enterprise-grade cloud platform can provide and how a leading life science organization is incorporating AI to accelerate its initiatives. Register now.
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Today’s Big NewsNov 21, 2023 |
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Decemeber 5, 2023 | The Edison Ballroom, NYC A celebration of the 50 key players, changemakers and innovators across biotech, pharma and healthcare. The Fierce 50 is a groundbreaking project to identify, elevate and celebrate the individuals and companies driving advancements in medicine, fostering innovation and shaping the future of biopharma and healthcare. Register Now!
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| By Angus Liu The U.S. Federal Trade Commission isn't letting up in its effort to crack down on pharma's alleged misuse of a patent mechanism in the FDA's regulatory process. And it's Sanofi’s turn to land in the crosshairs. |
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By Nick Paul Taylor BeiGene is buying its way into a cancer niche targeted by Bayer, Blueprint Medicines, Incyte and Pfizer, striking a backloaded, $1.33 billion deal for a global license to Ensem Therapeutics’ CDK2 inhibitor. |
By Conor Hale 10x Genomics said it plans to seek an injunction that would halt the sales of NanoString's spatial biology products, which make up a majority of the company's revenues. NanoString plans to appeal. |
By Fraiser Kansteiner GSK plans to start late-stage trials of a low-carbon version of its metered dose inhaler (MDI) Ventolin utilizing a next-generation propellant in 2024. If the new product proves successful, it has the potential to slash greenhouse gas emissions from Ventolin use by roughly 90%. |
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Tuesday, December 5, 2023 | 11am ET / 8am PT Clinical pharmacology information comprises more than 50% of a drug label. Join us for this objective webinar to review the clinical pharmacology-related regulatory hurdles that may lead to review issues or impact approvability of marketing applications, and discuss strategies to mitigate these. Register now.
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By Nick Paul Taylor Jean-Paul Kress’ words are coming back to haunt him. The MorphoSys CEO has said AbbVie “failed” its phase 3 myelofibrosis trial because the Big Pharma missed one of two endpoints and stated regulators want to see hits on both measures. Now, Kress is defending MorphoSys’ similarly mixed data on its $1.7 billion rival. |
By Andrea Park Just a week after issuing a notice giving its most serious rating to Cardinal Health’s recall of certain syringes, the FDA has put out a letter to healthcare providers warning that the recall may not go far enough. |
By Zoey Becker Moderna pledged to appeal after the European Patent Office ruled one of its patents invalid in the intellectual property battle that spans multiple countries. |
By James Waldron Merck & Co. has made no secret of its ongoing hunt for acquisitions, and, now, the Big Pharma is rounding off the year by swelling its preclinical pipeline with a selection of programs aimed Parkinson’s disease and beyond. |
By Kevin Dunleavy In its lawsuit, Texas says the companies knew that deficient manufacturing processes compromised the effectiveness of Quillivant XR. The lawsuit further accuses the companies of manipulating quality-control testing from 2012 to 2018 to ensure samples received passing grades. |
By Conor Hale Medtronic has secured not one but two new European approvals for its cardiac ablation devices to treat irregular heartbeats, while also delivering its second-quarter earnings results. |
By Zoey Becker With the high-stakes trial now on pause, the U.S. First Circuit Court of Appeals will review a prior ruling that determines how the case can play out. |
By James Waldron While a COVID-19 patent battle with Pfizer rumbles on, Enanta Pharmaceuticals has hit pause on development of a dual inhibitor for human metapneumovirus and respiratory syncytial virus in an effort to pave a cash runway into 2027. |
By Andrea Park The artificial pancreas system will begin its European launch this year in France and the Netherlands—the home countries of Diabeloop and ViCentra, respectively—and in Germany, before expanding further across the continent in 2024, to countries including the U.K. and Italy. |
Fierce podcastsDon’t miss an episode |
| This episode of "The Top Line" is dedicated to Alzheimer’s disease, spotlighting the latest treatments and what lies ahead. Fierce Pharma's Fraiser Kansteiner discusses Leqembi's full approval with Eisai's Alexander Scott. Annalee Armstrong from Fierce Biotech interviews Alzheimer's expert Howard Fillit, M.D., exploring groundbreaking research. Fierce Pharma’s Eric Sagonowsky speaks with Reisa Sperling, M.D., about Leqembi's potential in preventing Alzheimer’s progression before symptoms emerge. |
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Tuesday, November 28, 2023 | 11am ET / 8am PT Elevate your biopharmaceutical game! Join our webinar to explore game-changing solutions. Uncover the power of Recombumin® rHA – the consistent, animal-free alternative revolutionizing manufacturing. Don't miss this chance to stay ahead in the advanced therapy landscape.
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| WhitepaperAccelerate drug discovery with high-performance computing (HPC) powered by the cloud Sponsored By: AWS, NVIDIA, and Rescale |
| Whitepaper As a leader of technology transfer activities in the industry, Lonza understands the challenges associated with this critical step. Download this White Paper today to learn more. Sponsored by: Lonza |
| eBookEmulate in vivo biology with next-generation in vitro technology. Sponsored by: Emulate |
| Whitepaper A critical area to consider in selecting a CDMO is their ability to successfully complete technology transfers, which involves an intricate set of activities and disciplines that, if done incorrectly, could result in delays and failures that impact the overall success of your end product. Recognizing what it takes to complete this process effectively and efficiently is crucial to selecting the best partner for your project and product needs. This white paper delivers an analysis of critical success factors for effective technology transfer. Sponsored by: Lonza |
| WhitepaperLearn how to develop a high-performing supply chain for cGMP chemicals used throughout your bioprocessing workflows. Sponsored by: Thermo Fisher Scientific Production Chemicals and Services |
| WhitepaperDownload our whitepaper to learn about plasmid DNA design considerations for cell and gene therapy applications. Sponsored by: Aldevron, a GMP manufacturing CDMO of DNA, RNA, and Proteins |
| WhitepaperThis paper explores AI’s potential impact on healthcare and on Medical Affairs (MA) more specifically. It also outlines what MA teams can do now to proactively leverage AI to improve service to their stakeholders. Presented by Blue Matter, strategic consultants in the life sciences |
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