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This is the twenty-third edition (week ending 30-Aug-26) of our Pharma Weekly – In Case You Missed It. Key developments in the past week:

1) Teva has launched gJynarque (Tolvaptan) in the US, with the launch coinciding with the expiry of the ’730 patent. Lupin’s 180-day exclusivity in the product (currently the largest in its US portfolio) ended in Nov-25, and gJynarque is expected to become a four-player market with the imminent entry of Apotex and Alkem. In a separate development, Lupin has won a US patent infringement ruling against Vertex Pharma over its proposed generic version of Kalydeco (Ivacaftor) for cystic fibrosis.

2) Aurigene Pharma Services, a wholly-owned subsidiary of Dr Reddy’s, has entered into a long-term manufacturing and supply agreement with a leading global pharma company for >20 products across sterile injectables, biologics, and topicals for the US, Europe, Canada, and EMs. The portfolio is expected to reach ~18mnpa units at full commercialization, with phased technology transfers over 2-3 years and revenue expected to commence from CY28.

3) Eli Lilly received USFDA approval to expand Mounjaro’s (Tirzepatide) label to include the reduction in the risk of major cardiovascular events in at-risk adults with Type 2 diabetes. Mounjaro showed 8% lower rate of cardiovascular death, heart attack, or stroke versus Lilly’s prior-generation GLP-1 diabetes blockbuster Trulicity in phase 3 trials (read-through for Divi’s).

4) Celltrion has applied for Korean approval of its biosimilar to MSD’s Keytruda (Pembrolizumab) and plans to sequentially file in major markets including the US, EU, and Canada. Notably, Samsung Bioepis had announced its filing for a Korean approval earlier last month – the first regulated market filing for a Keytruda biosimilar (relevant for Zydus, Dr Reddy’s, Biocon, and Ipca Labs).

5) Neuren Pharmaceuticals received approval from the European Commission for Daybu (Trofinetide) for neurobehavioral symptoms associated with Rett syndrome, making it the first authorized treatment for the condition in the EU. The approval is expected to support a commercial launch by Acadia in Germany, in 4QCY26 (relevant for Sai Life)

6) The USFDA has accepted United Therapeutics's NDA for Ralinepag for the treatment of pulmonary arterial hypertension (PAH), with a PDUFA action date of 24-Jun-27. If approved, Ralinepag could become the first once-daily oral prostacyclin for PAH (relevant for Sai Life).

7) Rhythm Pharmaceuticals announced that Japan’s Ministry of Health, Labour, and Welfare (MHLW) has approved Imcivree (Setmelanotide) for acquired hypothalamic obesity (HO), making it the first approved treatment for the condition in Japan. The company expects to launch the drug by end-CY26 (relevant for Neuland).

8) PTC Therapeutics presented new clinical and real-world data for Sephience (Sepiapterin). New analysis demonstrated that Sephience resulted in a 100% greater reduction in blood phenylalanine among patients switching from Sapropterin (read-through for Laurus Labs).

9) BioCryst Pharma received approval from Japan’s MHLW for Orladeyo (Berotralstat), for prophylactic treatment of hereditary angioedema (HAE) in pediatric patients aged between 2 and <12 years. BioCryst plans to launch Orladeyo after the reimbursement pricing process of Japan’s National Health Insurance; it has filed for approval in Europe and Canada (relevant for Sai Life).

10) Dr Reddy’s has received CDSCO approval to manufacture and market its Abatacept biosimilar in India for moderate-to-severe rheumatoid arthritis and active psoriatic arthritis, subject to a Phase IV study.

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