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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 20, 2023 |
| By James Waldron Eli Lilly has taken a high-stakes gamble on oral IL-17 inhibitors, betting $2.4 billion upfront that acquiring Dice Therapeutics will expand its autoimmune arsenal. |
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By Nick Paul Taylor Gilead Sciences' $225 million bet on Arcellx’s CAR-T cell therapy has hit turbulence. Months after Arcellx closed the deal, the FDA has put a pivotal trial of the anti-BCMA therapy on hold in response to the death of a patient. |
By James Waldron Two months after dropping one of its GLP-1 agonists, AstraZeneca has decided to scrap its remaining clinical candidate. A preliminary analysis of the phase 1 data convinced the company that the drug would not outperform the competition. |
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 Max Bayer Santhera is transferring North American rights for a registrational-stage Duchenne's med to Catalyst as a strategic move to strengthen its financial position. Catalyst marks the fourth company to take on some rights to vamorolone, which is slated for an FDA approval decision in October. |
By Nick Paul Taylor Bavarian Nordic’s phase 3 chikungunya virus vaccine clinical trial has hit its primary endpoint, keeping the Danish drugmaker in the slipstream of Valneva’s near-approval candidate in the race to market. |
By James Waldron F2G’s hopes of getting the first in a brand-new class of antifungals to market have hit a setback courtesy of a complete response letter from the FDA. |
By James Waldron It’s been an eventful year so far for Molecular Templates—and not in a good way. The Bristol Myers Squibb-partnered biotech halved its head count in March to reduce costs, before its CD38-directed cancer candidate was hit by a two-month-long FDA hold that only lifted at the start of June. |
By James Waldron Bone Therapeutics may have escaped the graveyard thanks to a buyout by Medsenic last year, but the merged company continues to be haunted by clinical difficulties. |
By Helen Floersh Developing drugs to treat autism spectrum disorder, or ASD, is notoriously difficult, largely because scientists have yet to pin down the mechanisms behind the social and learning deficits that characterize it. But one company, Beyond Air, is betting on a new culprit: neural nitric oxide. |
By Annalee Armstrong,Max Bayer,Gabrielle Masson Fierce Biotech's M&A Tracker, your one-stop shop for dealmaking in the biopharma universe. |
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. |
By Helen Floersh A widely-available probiotic given orally showed benefits in a mouse model of dry eye disease, adding yet another potential indication for microbiome medicine. |
By Kevin Dunleavy In the battle for diabetes and obesity superiority, Novo Nordisk holds a head start as the original developer of the metabolism-regulating treatment semaglutide. But Eli Lilly is quickly gaining ground and is primed to become the market leader with its GLP-1 treatment Mounjaro, according to GlobalData. |
By Andrea Park BD announced Tuesday that it has inked a deal with Steris, an Irish maker of medical equipment used for sterilization and surgical procedures, to sell off its surgical instrumentation unit. |
By Angus Liu The largest multinational pharma company in China has reportedly made plans to separate its local business in case geopolitical tensions worsen. But the company is hitting back at the recent news report. |
By Dave Muoio The "worst financial year since the start of the pandemic" brought limited, and sometimes negative, revenue growth across the nation's largest nonprofit health systems. |
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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