AstraZeneca’s Koselugo recommended for approval in the EU for Neurofibromatosis type 1

The positive opinion is based on results from KOMET, the largest and only placebo-controlled, double-blind global Phase III trial in this patient population

GC Biopharma submits IND to begin Phase 3 clinical trial for Barycela in Thailand

Lonza reports 19% growth in sales in H1

Upgrades 2025 full-year CDMO sales and margin outlook

Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy

Capricor’s BLA for Deramiocel received Priority Review in March 2025

Panacea Biotec reaches settlement with Apotex

Apotex will also pay US$ 2.5 million upon receipt of final USFDA approval of the ANDA that is the subject of the Collaboration Agreement for Paclitaxel Protein-Bound Particles for Injectable Suspension

Aarti Pharmalabs achieves SBTi approval of GHG emission reduction targets

Aarti Pharmalabs becomes 6th Indian Pharma/CDMO to earn SBTi approval for all 3 Scopes since 2022 demerger

Lupin Q3 FY25 profit up 40% at Rs. 855 Cr

Revenue up 11% to Rs 5,768 crore as compared to Rs 5,197 crore

FDA RMAT status for Affimed and Artiva’s lymphoma combo therapy

Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients

European Commission approves Pfizer’s HYMPAVZI for treatment of severe Hemophilia A or B without inhibitors

HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors

Akums Drugs and Pharmaceuticals posts Q2 FY25 adjusted PAT at Rs. 66.7 Cr

For Q2, Akums reported a consolidated total income of Rs. 1,046.6 crore