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This is the sixteenth edition (week ending 12-Jul-26) of our Pharma Weekly – In Case You Missed It. Key developments in the past week:

1) BMS’s Krazati (Adagrasib) failed its confirmatory Phase 3 trial in mutated metastatic colorectal cancer, missing both progression-free survival and overall survival endpoints, thus creating uncertainty around conversion of its accelerated approval in the indication (read-through for Syngene).

2) Celltrion and Teva's Truxima (Rituximab) became the first interchangeable Rituximab biosimilar approved by the USFDA, enabling substitution with Rituxan (read-through for Dr Reddy’s).

3) Vertex Pharmaceuticals agreed to acquire Crinetics Pharmaceuticals for $10bn, gaining Palsonify—a newly approved potential blockbuster oral treatment for acromegaly, alongside Crinetics’s endocrine pipeline (readthrough for Anthem).

4) Vera Therapeutics's Trutakna (Atacicept) received USFDA approval for IgA nephropathy (IgAN), becoming the first dual BAFF/APRIL inhibitor for the disease, adding a new competitor to Novartis's Vanrafia in the rapidly expanding IgAN market (relevant for Anthem).

5) Teva has partnered with Samsung Bioepis to commercialize OPUVIZ (Aflibercept - biosimilar to Eylea) in Canada; Samsung Bioepis will manufacture and supply the product (relevant for Biocon).

6) Eli Lilly's Foundayo continues to see a muted launch, with weekly prescriptions remaining at ~20,000 over the past five weeks, well below Novo Nordisk's oral Wegovy, despite broader PBM coverage (relevant for Divi’s). Meanwhile, Novo Nordisk launched its oral Wegovy in the UK through private pharmacies, expanding access ahead of potential NHS availability.

7) A US court dismissed most of Amgen's counterclaims and defenses against Regeneron in the ongoing Eylea (Aflibercept) biosimilar patent litigation, although Amgen's marketed biosimilar (Pavblu) remains on the US market as the underlying patent case continues (Biocon has a settled launch date).

8) Novo Nordisk launched Awiqli (once-weekly insulin) in India for adults with type 1 and type 2 diabetes, with India becoming the seventh country where Novo has launched the product. The product is priced below comparable daily basal insulin on a per-week basis and will compete with Sanofi's Lantus and insulin glargine products from Eris and Lupin.

9) WuXi Biologics received USFDA Pre-License Inspection (PLI) clearance for its MFG8 drug substance facility in China, which houses twelve 4KL single-use bioreactors, supporting commercial manufacturing of a potential blockbuster autoimmune therapy (relevant given the scale of the capacity being added).

10) Amneal and Adalvo announced USFDA acceptance of their NCE-1 ANDAs for generic Tirzepatide autoinjectors referencing Mounjaro and Zepbound.

11) Novo Nordisk has partnered with Vivani Medical to develop NPM-139, an ultra-long-acting Semaglutide implant for obesity designed for once- or twiceyearly dosing, with a Phase 1 trial set to begin in coming weeks.

12) The National Pharmaceutical Pricing Authority (NPPA) has fixed retail prices for 39 new drug formulations across therapies, including cardiovascular, diabetes, antibiotics, oncology, and HIV.

13) The CDSCO has proposed restricting the extension of established brand names to medicines with different active ingredients, aiming to reduce patient confusion and medication errors.

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