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From risk mitigation to program-level country and site strategy, IQVIA helped help this sponsor prove operational feasibility for six concurrent global studies. Download the case study. 
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| By Eric Sagonowsky After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing. |
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By Nick Paul Taylor Novartis wants to give a $3.2 billion lift to its kidney disease pipeline. While working to generate phase 3 data on its own IgA nephropathy candidate, the Swiss drugmaker has seized the chance to buy Chinook Therapeutics for a pair of late-stage programs targeting the rare, progressive chronic kidney disease. |
By Andrea Park On the heels of sharing study results demonstrating that its Bio-RFID technology could accurately measure blood sugar levels completely noninvasively, Know Labs has built the first iteration of the hardware that’ll house that technology. |
By Angus Liu David Epstein’s short tenure as Seagen’s CEO will likely end soon with the antibody-drug conjugate specialist’s sale to Pfizer. After a rich career spanning companies of various sizes, Epstein is keeping an open mind about where he might head next. |
By Max Bayer Lilly is aware of and “closely looking into” anecdotes that patients taking GLP-1 drugs seem to have an easier time quitting alcohol or cigarettes—but proving a genuine impact is easier said than done. |
By Angus Liu Bayer recently laid out its ambition to achieve $10 billion in sales from its oncology business by 2030 and become a top 10 cancer drug player. To get there, the company is looking outside for a “midsize acquisition,” Bayer’s oncology chief Christine Roth said. |
By Nick Paul Taylor AstraZeneca is joining Bristol Myers Squibb in the emerging autoimmune cell therapy space, paying Quell Therapeutics $85 million upfront to collaborate on candidates including a “one and done” cure for Type 1 diabetes. |
By Zoey Becker Sanofi's new app, plai, provides teams with a “360° view" to aid decision-making. The platform is one step in the company's digital transformation and goal to become the "first pharma powered by AI at scale." |
By Ayla Ellison Francis deSouza has resigned as CEO and director of Illumina after recently surviving activist investor Carl Icahn’s proxy fight against the company, which involved demands to remove deSouza from the DNA sequencing company’s board and replace him as chief executive. |
By Angus Liu Biogen has taken a step to “significantly refresh” its board of directors, departing chair Stelios Papadopoulos, Ph.D., said. But the reported romantic relationship between a new nominee and a departing member raises questions about one appointment. |
By Nick Paul Taylor Investigators have paused an early-phase trial of 2seventy bio’s CD33-targeted CAR-T cell therapy after a patient died. The acute myeloid leukemia (AML) patient was the first person treated in the second dose cohort of the phase 1 clinical trial. |
By Kevin Dunleavy An FTC lawsuit aimed at blocking Amgen’s $27.8 billion buyout of Horizon Therapeutics has raised concerns that the United States’ antitrust watchdog is tightening the screws on major M&A moves in the biopharma industry. A month later, according to an SEC filing, Pfizer has withdrawn its notification for its proposed $43 billion acquisition of cancer drug specialist Seagen and will submit another later in the day. |
By Joseph Keenan BC Platforms, known for its healthcare data and analytics systems, snapped up the Scandinavian CRO 4Pharma as part of a move to expand its services. |
By Kevin Dunleavy Bristol Myers Squibb took a positive step toward beefing up its cell therapy manufacturing capabilities as the FDA gave the go-ahead for the company to begin commercial production at its sprawling facility in Devens, Mass. |
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 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 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 |
Executive Summary Traditional real-world data isn’t truly from the real world – it’s from the clinical world, and it’s missing a big part of neuro patients’ stories. Sponsored by: Evidation Health |
Whitepaper Building a Sustainable Blueprint for a Holistic Market Access Strategy Sponsored by: EVERSANA® |
Whitepaper Modern software development and its impact on addressing clinical trial complexity. Sponsored by: YPrime |
Whitepaper Drive brand growth with proven digital strategies to accelerate and optimize all lifecycle stages including drug discovery, launch, maturity and LoE. Sponsored by: LiveWorld full-service digital agency with deep social expertise |
Research There’s a $70 billion growth opportunity for pharma and medtech in transitioning care from the hospital to home. Read our latest report to find out how we can create better patient outcomes and drive health equity. Sponsored by: PA Consulting |
Research What role do the Library and Legal teams play in the drug development pipeline at Lilly? An import one – find out how. Sponsored by: CCC |
| July 18-19, 2023 | Jersey City, NJ |
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