| Today's Big NewsJan 19, 2023 |
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Register for the virtual Bionano Symposium 2023 and learn how optical genome mapping (OGM) can outperform traditional cytogenetic methods so you can easily screen cell lines for genomic instability and off-target events. 
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| By Angus Liu Nearly three years after snatching the first-in-class FDA approval in metastatic liver cancer, a combination of Roche’s Tecentriq and Avastin has come back with an industry-first win in early-stage disease. And the PD-L1 inhibitor is looking at a busy year with potentially four adjuvant readouts on deck. |
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By Paige Minemyer Health insurers have a neutral credit outlook for the coming year as the increased focus on diversification paid off, according to a new analysis from Fitch Ratings. |
By James Waldron Just 10 days after announcing plans to let go of its iNK programs as part of a major portfolio and workforce restructuring, Editas Medicine has found a buyer for the cell technologies in the form of Shoreline Biosciences. |
By Zoey Becker NICE endorsed costly rare disease therapies from Alnylam and PTC Therapeutics. As for PTC's Translarna, the drug has been rejected by the U.S. FDA three times. |
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Thursday, December 15, 2022 |2:00pm ET / 11:00am PT This talk emphasizes the role of partnerships between early- and late-stream analytical assay developers while tackling unique challenges in validating flow cytometric methods for Chimeric Antigen Receptor (CAR) T cells, during manufacturing and clinical monitoring. We will be introducing Critical Quality Attributes and key considerations when designing sample preparation methods, optimization, validation, and implementation for cell and gene therapy bioanalytics. Register now. 
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By Andrea Park No seven-year itch here: After spending the better part of a decade putting aside their differences to team up on the combination of their respective patient monitoring technologies, Philips and Masimo are still going strong. |
By Dave Muoio In an address to Cleveland Clinic employees, CEO and President Tom Mihaljevic, M.D., said the organization plans to cut back on spending and administrative hiring. |
By Nick Paul Taylor Fresh from its $325 million opt-in, Jazz Pharmaceuticals has posted phase 2 data on its HER2-targeted bispecific antibody zanidatamab. The Zymeworks-partnered prospect kept 84% of people with metastatic gastroesophageal cancer alive for at least 18 months when given in combination with chemotherapy. |
By Conor Hale More than a year-and-a-half after securing an approval in Europe, Abbott has gotten the green light from the FDA for the newest generation of its transcatheter aortic valve replacement implant. |
By Robert King CMS leadership held a roundtable with providers Tuesday aimed at getting feedback on proposed reforms to prior authorization, including new measures to adopt electronic processes. |
By Eric Sagonowsky Just about a week after saying its cash could fund operations until early next year, bluebird bio has raised $113 million by selling new shares of its stock. The money should fund operations through the fourth quarter of 2024. |
By Gabrielle Masson If there's been a theme to 2023 so far, it's mid-size companies taking the plunge and making an offer on their biotech peers. The latest example is Sun Pharmaceutical, which has put down $576 million to acquire Concert Pharmaceuticals and its JAK inhibitor that could give Eli Lilly's approved alopecia treatment a run for its money. |
By Andrea Park Surmodics looks to pave a new path forward after the FDA sent a device submission back for revision yet again. |
By Angus Liu Intercept has moved one step closer toward its goal of delivering the first NASH therapy in the U.S. The FDA has accepted the company's latest application for Ocaliva in NASH, but uncertainties remain following a 2020 rejection and a phase 3 failure. |
By Annalee Armstrong 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. |
Fierce podcasts Don't miss an episode |
| This week on “The Top Line,” we discuss the FDA's shifting stance on cancer drug approvals. Plus, we cover the annual JPM week and other top headlines from this week. |
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Tuesday, January 24, 2023 | 11am ET / 8am PT Your CRO is a finalist in a project bid and clinical supplies are one of the aspects that you will manage on behalf of the client via a partner. Register now. 
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Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
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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 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 |
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