In the competitive oral SERD space for breast cancer, companies like Roche and AstraZeneca are differentiating not by proving superior degradation mechanisms but by pursuing approvals in first-line and adjuvant settings, sidestepping the crowded second-line market to find the biggest impact.
The upcoming PDUFA date for Arvinus's Vepdegestrant is more than a milestone for breast cancer treatment. Its approval would be the first for a PROTAC, validating the rationally designed targeted protein degrader platform and boosting confidence across a wide range of diseases beyond oncology.
The FDA's complete response letter for Disc Medicine's orphan drug, which questioned the clinical relevance of a biomarker, is causing widespread concern. This decision challenges the long-standing paradigm of using biomarkers for accelerated approval, a cornerstone of development for rare diseases.
Political strategists are advising a shift away from overtly anti-vaccine messaging. The new, more insidious approach focuses on promoting 'medical freedom' to erode childhood vaccine mandates and remove liability protections for manufacturers, which could make marketing some vaccines in the U.S. untenable.
FDA CBER Director Vinay Prasad is reportedly overriding staff recommendations not just in his own center (vaccines), but also in CEDAR (drugs), as seen in the Disc Medicine case. This consolidation of decision-making power in one individual is making FDA approvals far more unpredictable for drug developers.
The current unpredictability at the FDA is so pronounced that prominent biotech investor Peter Kolchinsky of RA Capital is now advising his portfolio companies to de-risk development by conducting early-stage clinical trials outside the United States. This marks a significant strategic shift for US-based innovators.