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FDA has paused public release of complete response letters while reviewing a citizen petition challenging the legal basis of the practice, stalling a transparency initiative the agency launched less than a year ago.

FDA has approved Sarclisa Escena as the first anticancer treatment administered via an on-body injector, offering multiple myeloma patients and providers a subcutaneous alternative to time-intensive IV infusions across all three of isatuximab's existing indications.

AstraZeneca's Wainua failed to meet the primary endpoint of a late-stage trial in transthyretin-mediated amyloid cardiomyopathy, sending shares down nearly 10% in their largest single-day decline since late 2024.

This case could redefine the legal boundary between protecting pharmaceutical patents and allowing lower-cost generic drugs onto the market.

In today's Pharmaceutical Executive Daily, FDA approves Ennumo, a pharma roundup covers Chemomab Therapeutics' merger with AI-enabled precision medicine company Scipher Medicine and Teva's global licensing agreement with Polpharma Biologics, and Alina Chesnokova of Cencora examines how the rise of cold chain-dependent specialty therapies is fundamentally changing how pharmaceutical manufacturers think about commercialization strategy and supply chain partnerships.

FDA has approved Accord BioPharma's Ennumo as a second pegfilgrastim biosimilar, giving the company what it claims is the world's largest G-CSF biosimilar portfolio from a single manufacture.

Chemomab and Scipher Medicine agreed to merge in an all-stock deal to advance an anti-CCL24 antibody into an AI-guided Phase II rheumatoid arthritis trial, while Teva struck a global licensing deal with Polpharma Biologics for exclusive commercialization rights to a proposed ocrelizumab biosimilar across major markets.

In today's Pharmaceutical Executive Daily, Novartis files notices to lay off 322 employees at its East Hanover, New Jersey location, Evogene partners with Tel Aviv University's Blavatnik Center for Drug Discovery to accelerate AI-powered small-molecule discovery, and Sanofi's Chief Digital Officer Emmanuel Frenehard on why genuine AI transformation requires concentrated investment—not just automation.

The two companies will work together to advance the development of small molecule discovery at the research center.

Sanofi Chief Digital Officer Emmanuel Frenehard on scaling AI across a Big Pharma global enterprise and why a strategy of concentrated AI bets — not scattered pilots — can better drive real transformation without losing sight of governance, culture or patients.

In today's Pharmaceutical Executive Daily, Vertex Pharmaceuticals announces a $10 billion acquisition of Crinetics Pharmaceuticals and its approved acromegaly therapy Palsonify, Catalent expands its partnership with Nanoscope Therapeutics to support potential commercialization of an optogenetic gene therapy for retinal degenerative diseases, and Cencora's Alina Chesnokova examines how the rise of specialty therapies is making cold chain logistics a front-line strategic priority.

Catalent will support Nanoscope’s commercialization of Nanoscope’s MCO-010.

The deal will bring Palsonify into Vertex’s pipeline.