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Cell therapy trials are complex and successfully operationalizing these studies requires careful consideration of the interplay between the patient journey and vein-to-vein logistics workflow. Download our guide to learn how to optimize this process, including key steps in study execution and improving study retention.
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Today's Big NewsJun 21, 2023 |
| 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. |
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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. |
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. |
Sponsored by Invest Puerto Rico Puerto Rico is becoming the best place in the world to conduct R&D activities for emerging technologies. Could your organization maximize growth potential by capitalizing on Puerto Rico’s unique tax incentives & culture of innovation? |
By James Waldron With no hopes of a merger riding to the rescue, Bioasis is suspending operations and counting down the last days before its creditors call in over $4 million in loans. |
By James Waldron Union Therapeutics has highlighted the latest phase 2 results for its anti-inflammatory drug in a painful skin condition as the Danish biotech prepares for a pivotal study in the indication. |
By Nick Paul Taylor AIDS advocates are keeping up the pressure on Gilead Sciences. After mounting attacks on both sides of the Atlantic, the AIDS Healthcare Foundation protested outside Gilead’s California headquarters as part of “yearlong aggressive advocacy campaign” to hammer the big biotech’s “drug profiteering.” |
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 Teresa Carey This week on "Podnosis," we talk about the momentum behind addressing health equity challenges. Also under discussion is how social drivers of health are finally being recognized by CMS. |
By Kevin Dunleavy Novo Nordisk filed five lawsuits in four states on Tuesday, charging health spas, clinics and pharmacies with false advertising, trademark infringement and unlawful sales of compounded versions of diabetes and weight loss drugs Ozempic and Wegovy. Novo also is planning action against other unlawful sellers, the company said. |
By Annie Burky More than 90% of respondents to a recent U.S. News and World Report survey said their goal is to age in place. A whopping 88% also reported that assistive or health-related technologies have improved their quality of life. |
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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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 Discover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
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 Planning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial. 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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