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Pharmaceutical Executive Daily: FDA Grants Ultomiris Accelerated Approval in the U.S.

Roundup: Alcon Acquires Neurotech and Encelto, Ai Proteins Enters Research Collaboration and License Agreement with Astellas Pharma

FDA Grants Ultomiris Accelerated Approval in the U.S. for Adults with Primary Immunoglobulin A Nephropathy

Pharmaceutical Executive Daily: FDA Approves Hibsago

Median Drug Launch Prices Hit $257,000 as Access Barriers Persist, ICER and West Health Report Finds

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The FDA approved GSK's bepirovirsen for adults with chronic hepatitis B on nucleoside therapy, based on phase 3 trials showing 19% functional cure.

Deborah Waterhouse is leaving ViiV Healthcare to become CEO and managing director of CSL.

Incubate’s John Stanford on why MFN’s first casualty is the moonshot — and why cancer, Alzheimer’s, and rare disease bear the cost.

METiS TechBio and Eli Lilly collaborate on next-generation LNP delivery technology, Incubate’s John Stanford on how MFN deals may shape future pharma decisions, and the FDA grants accelerated approval to GSK’s Jemperli for MSI-H/dMMR locally advanced rectal cancer.

METiS TechBio enters a collaboration with Eli Lilly to develop next-generation, tissue-specific lipid nanoparticle delivery technologies using METiS’s AI-driven lipid discovery platform.

Incubate’s John Stanford on why MFN reduces pharma’s appetite for biotech acquisitions — and why that cedes ground to China.

FDA’s conditional approval of Jemperli (dostarlimab-gxly) rests on a single-arm phase 2 trial, with independent-review data still maturing.

Merck KGaA, Darmstadt, Germany, acquires Silence Therapeutics for $1.3 billion, Hansoh Pharma and Roche expand their ADC partnership in a deal worth over $15 billion, and an EMA panel backs Lilly’s Foundayo for obesity and type 2 diabetes in Europe.

Merck KGaA, Darmstadt, Germany, agrees to acquire Silence Therapeutics for roughly $1.3 billion, gaining a siRNA asset, divesiran.

Hansoh Pharma enters a collaboration and license agreement with Roche covering a broad portfolio of antibody-drug conjugate programs.

Foundayo’s EU backing, Enspryng for TED, Gilead’s masked TCE deal, FDA’s rare disease reset, and Bausch + Lomb’s new interim CEO — explained.

Incubate’s John Stanford on why MFN deals are voluntary in name only — and why the leverage looks a lot like the IRA’s 95% excise tax.

Lilly’s Foundayo receives a positive CHMP opinion for obesity and type 2 diabetes — putting the oral GLP-1 pill on course for EU approval.

The interleukin-6 receptor inhibitor gains a second indication, though one of two phase 3 trials missed its primary endpoint.

European regulators are increasing pressure on clinical trial sponsors to report study results on time, rolling out new monitoring, reminders and guidance as patient advocates welcome the progress but question whether stronger oversight and enforcement will follow.
























