FDA Issues CRL to Sobi for NASP in Uncontrolled Gout, but the letter did not attack the clinical case. It attacked ...

4SigHT is formally a long-term observational study. Strategically, its timing points to something larger: Tanabe is building a Japanese real-world evidence moat before Bristol Myers Squibb brings a ...

Tanabe’s Uplizna Defense: Obexelimab Had Already Won Phase 3 | Witfire Elite View Witfire Elite Competitive Strategy Case Studies Japan Pharma Long Read Pharma Market Case Studies Witfire Elite View ...

Phase 3 Data, Capital Structure and the Cost of Independence Revolution Medicines has not eliminated acquisition interest. It has eliminated the financial urgency that could force it to accept an ...

Four months after FDA refused to file Moderna’s application, its vaccine advisers unanimously supported its benefit-risk profile in adults aged 50–64 and again in adults aged 65 and older. Same ...

GSK’s $10.6B Nuvalent acquisition is more than an oncology deal. It is a pre-approval bet on zidesamtinib, neladalkib, and two FDA decision dates in 2026.

FDA rejected Replimune’s RP1 despite a 34% response rate in advanced melanoma. The rejection centered on single-arm trial design and evidence standards.

Western pharma wants Chinese innovation but less China execution risk. That gap could become India’s next CRO/CDMO opportunity if Indian firms can become the trusted bridge. The market keeps asking ...

The Iran war did not create India’s pharma vulnerability. It exposed it. The real story is not that oil prices moved, ships rerouted, or freight became more expensive. Those are transmission channels.

At ADA 2026, Lilly’s retatrutide Phase 3 data pushed the obesity conversation into a new zone, with the 12 mg dose showing 28.3% average weight loss at 80 weeks. Earlier, Novo’s CagriSema had been ...