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Today's Big NewsJun 22, 2023 |
| By Zoey Becker After the FDA said it needed "modest additional time" to review the therapy, the agency has ultimately approved the Duchenne muscular dystrophy gene therapy under the accelerated approval pathway. It's now branded as Elevidys. |
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By Andrea Park Since flapping its wings and leaving the General Electric nest at the start of this year, GE HealthCare has devoted much of its energy toward broadening its newly solo horizons. |
By Max Bayer Federation Bio is joining the layoff ranks, cutting loose an undisclosed number of employees. The company dosed the first patient in its first clinical trial at the end of 2022. |
By Kevin Dunleavy The CDC's Advisory Committee on Immunization Practices has recommended that adults 60 and older—in consultation with their doctors—receive vaccines to prevent lower respiratory tract disease caused by respiratory syncytial virus. The thumbs-up, however, was anything but enthusiastic. |
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Wednesday, July 12, 2023 | 2pm ET / 11am PT In this webinar, we will explore how critical it is for life sciences companies to use data to analyze the behavior of cancer at the individual level, uncover new targets and biomarkers for precision therapies, and increase the value of existing oncology drugs to new indications. Register now. 
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By Gabrielle Masson UniQure’s stock has hit a six-year low after an interim data drop for a study evaluating its investigational gene therapy for Huntington’s disease. |
By Kevin Dunleavy The European Medicines Agency (EMA) has ramped up its scrutiny of GLP-1 treatments, raising a safety signal about the potential risk that the diabetes and obesity drugs could cause cancer. The move is a first step for the regulator in monitoring the potential for adverse events that could be related to use of approved drugs. The EU notified Novo Nordisk about the signal last month, the company told Danish news outlet B.T. |
By Andrea Park For the fourth time in half as many years, Anumana has earned the FDA’s breakthrough device designation for another of its artificial intelligence algorithms designed to catch hard-to-spot heart conditions in their earliest stages. |
By Helen Floersh Startup Amplifica is looking to turn the molecule that makes hair grow in moles into a viable therapy for androgenetic alopecia. |
By Zoey Becker Trade group PhRMA is the latest to go after the IRA in a lawsuit claiming violations of the Fifth and Eighth amendments. The suit follows similar legal efforts by Merck and Bristol Myers Squibb. |
By Gabrielle Masson,Max Bayer,Annalee Armstrong Alongside the new year, we've launched a new Fierce Biotech Fundraising Tracker to keep the pulse on the industry's financing. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we discuss the the top news from this year's annual BIO meeting, plus a COVID lawsuit, an FDA-approved app and the rest of the week's headlines. |
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Wednesday, July 12, 2023 | 11am ET / 8am PT Join us for this insightful discussion on how to unlock the full potential of liquid biopsy and be an integral part of the future of precision medicine. We’ll take a deep dive into the latest strategies and solutions designed to help overcome current challenges and empower researchers and clinicians with enhanced capabilities. Register now. 
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Whitepaper Learn 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 |
Whitepaper Autoantibody screening is promising for early cancer detection with the potential to improve the whole treatment decision tree, providing a less invasive, powerful approach. Sponsored by: Sengenics |
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 |
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 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 |
eBook See how clinical trial sponsors can build stronger strategies to address challenges across the patient enrollment funnel, starting with four necessary steps. Sponsored by: OneStudyTeam |
Whitepaper This paper outlines various market archetypes and key considerations leaders must address when prioritizing new potential markets for gene therapies. Sponsored by: Blue Matter, strategic consultants in the life sciences |
| July 18-19, 2023 | Jersey City, NJ |
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