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Market and value analysis positions neurotech startup for successful U.S. product commercialization and adoption. Learn how. .png)
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Today's Big NewsJun 21, 2023 |
| By Nick Paul Taylor Boston Pharmaceuticals has posted early evidence that its ex-Novartis candidate works in nonalcoholic steatohepatitis. But with Akero Therapeutics and 89bio taking rival drugs to the cusp of phase 3, it's unclear whether the biotech can differentiate BOS-580 from more advanced candidates. |
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By Andrea Park Nearly a decade after the original Cologuard test received premarket approval from the FDA and became a blockbuster hit as a screening tool for colorectal cancer, its maker Exact Sciences is planning to release a sequel. |
By Eric Sagonowsky Takeda says a "manufacturing delay" and increased demand are driving its supply shortfall for ADHD med Vyvanse. |
By Max Bayer Nutcracker Therapeutics has laid off a dozen employees, according to two sources familiar with the decision. A spokesperson declined to comment on the layoffs. |
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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 Kevin Dunleavy Merck is back home again in Rahway, New Jersey, at the site that it established 90 years ago as Merck Research Laboratories. After being headquartered for eight years, seven miles to the north in Kenilworth, and before that, for 23 years in Whitehouse Station, 35 miles to the west, Merck has returned to its “reimagined” Rahway facility. |
By Andrea Park It’s taken two years, but Surmodics has finally secured the long-awaited premarket approval from the FDA for its SurVeil drug-coated balloon. |
By Nick Paul Taylor AstraZeneca has pulled the plug on clinical trials of its asthma candidate elarekibep after seeing data from a toxicology study. Pieris Pharmaceuticals, which licensed the inhaled IL-4 receptor alpha inhibitor to AstraZeneca, attributed the decision to “lung findings” from a 13-week nonclinical assessment. |
By Zoey Becker Australian biotech Vaxxas, known for its needle-free vaccine technology, opened a new manufacturing facility in Brisbane, Australia. The plant will support the company's late-stage clinical trials and potentially its first commercial launches. |
By Max Bayer The latest Flagship venture has hit the scene, with Empress Therapeutics unveiling with $50 million to be a leader in small molecule development. The company plans to file four INDs with the FDA over the next two years. |
By Andrea Park Nearly two years ago, Owlet pulled its Smart Sock from the market after the FDA issued a warning letter condemning the unregulated device’s use in alerting parents when their babies’ heart rates or blood oxygen levels left predetermined healthy ranges. |
By Angus Liu,Kevin Dunleavy,Eric Sagonowsky In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning. |
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 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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