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In today's Pharmaceutical Executive Daily, a new industry analysis warns that direct-to-patient pharma platforms are scaling faster than the safety infrastructure needed to support them, FDA issues a complete response letter to Elevar Therapeutics over manufacturing deficiencies in its liver cancer combination therapy, and Insilico Medicine deepens its partnership with China Medical System Holdings in a new AI-powered drug discovery collaboration worth up to $177 million.

David Hung, Nuvation Bio’s CEO, explains the company’s focus on providing patients with better drugs.

Insilico Medicine has deepened its partnership with China Medical System Holdings with a second CNS-focused collaboration in three months, pairing Insilico's PandaOmics-identified mechanism with CMS's clinical and commercial infrastructure in a deal worth up to $177 million in milestones.

FDA issued a complete response letter to Elevar Therapeutics for its rivoceranib and camrelizumab combination in first-line hepatocellular carcinoma, rejecting the application over manufacturing deficiencies rather than clinical concerns.

The pharmaceutical industry has spent the last two years debating whether direct-to-patient pharma business models are real. That debate is over.

In today's Pharmaceutical Executive Daily, FDA quietly pauses its real-time public release of complete response letters, FDA approves Sanofi's Sarclisa Escena as the first anticancer treatment in the U.S. to be administered via an on-body injector, and AstraZeneca shares fall nearly 10 percent after its Phase III Cardio-TTRansform trial of Wainua in transthyretin-mediated amyloid cardiomyopathy fails to meet its primary endpoint.

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.

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.