| Today’s Big NewsFeb 5, 2024 |
| By James Waldron With the IPO window now firmly wedged open, Metagenomi is the latest biotech to set out expectations for going public—even if they are slightly more modest than peer companies have seen in recent weeks. |
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By Nick Paul Taylor Johnson & Johnson’s $6.5 billion autoimmune drug has hit the mark in a phase 3 trial. The success tees J&J up to talk to regulators about approving the anti-FcRn antibody in generalized myasthenia gravis (gMG), although questions about the competitiveness of the late-to-market asset remain unanswered. |
By Gabrielle Masson After resigning from her role as medical officer at CRISPR Therapeutics, Phuong Khanh Morrow, M.D., is taking on the role of head of oncology therapeutic area unit at Takeda. |
Sponsored by ICON In this exclusive interview, ICON Biotech President Chris Smyth paints a picture of the operating environment facing biotechs in 2024. |
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Donor diversity’s impacts on research is an important topic gaining increasing attention. BioIVT recently presented a poster examining phase I & II activities in hepatocytes and microsomes. Read More >>
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By Max Bayer The highest dose of Pliant's liver disease treatment passed a phase 2 data, showing that it was safe and tolerable. But exploratory efficacy failed to differentiate from lower doses. |
By Nick Paul Taylor 4D Molecular Therapeutics has linked its gene therapy to a 90% reduction in treatment burden in wet age-related macular degeneration (AMD), emboldening it to start planning to enter phase 3 next year. |
By Gabrielle Masson Pfizer is putting down $15 million to launch a new program with the American Cancer Society aimed at improving access to cancer screening and clinical trials in medically underrepresented communities nationwide. |
By James Waldron Vaccine maker Valneva is giving its R&D unit a $103 million gift courtesy of selling an FDA priority review voucher for tropical disease. |
By Eric Sagonowsky,Kevin Dunleavy,Angus Liu,Fraiser Kansteiner,Zoey Becker Last year, the value of the top 10 M&A deals in the biopharma industry came to $115.8 billion, outranking prior sums from 2022, 2021 and 2020, which came to $65 billion, $53 billion and $97 billion, respectively. This report breaks down the industry's 10 largest M&A agreements of the year. |
By Fraiser Kansteiner Late last month, Novo Holdings’ CEO Kasim Kutay hinted that the fund manager was eyeing buyouts as an outlet for its trove of Wegovy cash. Now, a major deal has materialized. |
By Andrea Park That brings the total number of medical device reports received since April 2021 to more than 116,000, with 561 reported deaths. |
By Angus Liu Mark your calendars, oncology drug and CAR-T therapy developers. The FDA has decided on a date for a highly anticipated advisory committee meeting for Bristol Myers' Abecma and J&J's Carvykti. |
Fierce podcastsDon’t miss an episode |
| | This week on “The Top Line,” Fierce’s Conor Hale interviews Peter Shen, the North American head of digital health at Siemens Healthineers, to explore what developers and regulators can do to ensure transparency in medical AI. He also dives into how the field could potentially benefit from a 21st-century update to the Hippocratic Oath. |
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Stability and particle formation are key variables across the lifecycle. New instruments that improve measurement are transforming testing and becoming necessary. Download this essential reading now for biopharma companies that want to understand how particle detection is evolving and the value new technologies provide across the lifecycle.
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| Whitepaper This paper offers a detailed review of key events and developments in the oncology market during 2023. It’s a helpful “status report” that informs how the market is likely to evolve in 2024. It covers, vaccines, radiopharmaceuticals, ADCs, CAR-Ts, bi-specifics, & more. Presented by Blue Matter, strategic consultants in the life sciences |
| Whitepaper Discover how to effectively classify highly potent APIs and the steps required to develop containment protocols and manufacturing processes that are both safe and efficient. Sponsored by: Catalent |
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