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What’s in Today’s Brief? (September 6th Preview)
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FDA Accelerates Transparency on Drug Rejection Letters
The U.S. Food and Drug Administration (FDA) has taken a decisive step toward transparency by committing to publish complete response letters (CRLs) to drugmakers promptly after issuance. Following an initial unprecedented release of over 200 CRLs in July, the FDA disclosed an additional batch of 89 previously unreleased letters dating from 2024 to 2025, including rejections involving prominent developers such as Replimune, Capricor Therapeutics, and Ultragenyx. FDA Commissioner Marty Makary emphasized the public's interest in agency decision-making transparency and the adherence to an executive order mandating communication of scientific data. This development sheds new light on the agency's regulatory decision processes and sheds fresh insight into prior controversial rejections, such as Zealand Pharma’s glepaglutide in short bowel syndrome, highlighting concerns about data inconsistencies and unreported adverse events.
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Atlas Venture Raises $400M to Support Biotech Startups
Atlas Venture, a leading biotech investment firm, secured $400 million for its third Opportunity Fund aimed at financing growth-stage companies within its portfolio. This strategic fund targets young biotech startups facing funding challenges in a subdued investment climate, providing them with essential resources to advance drug development. The new fund reflects Atlas’ refined approach to raising capital tailored to its seed-led venture creation strategy. The firm’s portfolio boasts successes like Alnylam Pharmaceuticals and recent spinouts poised for growth. Atlas aims to maintain discipline and focus after prior rapid expansions, supporting innovation through patient capital amid current industry headwinds.
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BioNTech and DualityBio Achieve Phase III Breast Cancer ADC Success
BioNTech SE and its partner Duality Biologics announced a Phase III interim analysis showing that their HER2-targeting antibody-drug conjugate (trastuzumab pamirtecan) met the primary endpoint of progression-free survival in patients with HER2-positive unresectable or metastatic breast cancer previously treated with trastuzumab and taxane chemotherapy. This breakthrough marks BioNTech's first Phase III oncology success and positions Duality Biologics to pursue regulatory approval in China following its successful China-based trial. The milestone reinforces the therapeutic potential of HER2 ADCs in difficult-to-treat breast cancers and sets the stage for global regulatory submissions and future clinical development.
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Groundbreaking Allogeneic CAR T Therapy for Multiple Sclerosis
Clinicians at the University of Nebraska have pioneered a first-of-its-kind treatment for multiple sclerosis (MS) using an off-the-shelf allogeneic CAR T-cell therapy, azercabtagene zapreleucel (azer-cel). This therapy is designed to target overactive immune cells in the central nervous system implicated in MS-driven neurodegeneration. Early trial participants have reported significant clinical improvements, including enhanced gait and better overall function. Progressive MS represents an unmet medical need due to the limited efficacy of current therapies within the central nervous system. This Phase I clinical trial, sponsored by TG Therapeutics, offers hope for durable control of disease progression through cellular immunotherapy.
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Innovative AI-Driven Oncology Diagnostics from Imagene
Imagene, a Miami-based precision oncology diagnostics company, is advancing AI-powered technologies to enhance cancer treatment decision-making. Leveraging an Oncology Intelligence foundation model trained on over 1.5 million biopsy images across 40 tissue types, Imagene integrates genomic, proteomic, and spatial biomarker data to predict cancer patient outcomes and stratify patients for clinical trials. Supported by notable investors including Oracle founder Larry Ellison, the platform provides tools for identifying prognostic biomarkers and designing clinical trials, aiming to personalize therapeutic approaches and improve clinical success rates in oncology.
...and 5 more selected Biotech stories in today’s full edition.
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