Skip to content Skip to footer
Subscribe Now
NEWS
Gedeon Richter and Hikma Pharmaceuticals Receive the US FDA’s Approval for Enoby and Xtrenbo (Biosimilar, Prolia & Xgeva)
Shots: The US FDA has approved Enoby (RGB-14-P) & Xtrenbo (RGB-14-X), biosimilar versions of Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disorders Approval was based on extensive clinical data submitted by Hikma, incl. analytical, non-clinical & clinical studies, which showed comparable quality, efficacy, safety & immunogenicity of Enoby & Xtrenbo to reference…
2 days ago0Comments
Astrazeneca and Daiichi-Sankyo New
NEWS
Daiichi Sankyo and AstraZeneca Report the Topline P-III (DESTINY-Breast05) Trial Data of Enhertu for High-Risk Early Breast Cancer
Shots: The global P-III (DESTINY-Breast05) trial data assessed Enhertu (trastuzumab DXd; 5.4mg/kg) vs trastuzumab emtansine in 1,635 HER2+ primary breast cancer pts with residual invasive disease in breast or axillary lymph nodes after neoadj. therapy & a high risk of recurrence Trial showed improved invasive disease-free survival (1EP), while OS (2EP) was immature during interim…
2 days ago0Comments
EVENTS
Post Conference Highlights: Peptides & Complex Generics Symposium 2025
Day 1 Breakdown The #PCG2025 Symposium commenced on an inspiring note, setting the stage for two days of insightful discussions, collaborations, and knowledge exchange. Opening Session Dr. Ratnesh Jain, Founder & Director, Mumbai Cluster, delivered the inaugural address, sharing his vision of bringing together pharma professionals, R&D experts, CXOs, and academicians to accelerate advancements in…
2 days ago0Comments
Merus
NEWS
Genmab to Acquire Merus for ~$8B
Shots: Genmab has entered into a transaction agreement to acquire Merus, incl. its lead asset petosemtamab, expanding its late-stage pipeline & accelerating Genmab’s shift to a wholly owned model As per the deal, Genmab will acquire Merus for $97 per share in an all-cash transaction, representing the deal value of ~$8B, with closing expected in the…
2 days ago0Comments
NEWS
Amneal Pharmaceuticals Reports the US FDA’s BLA Filing for Biosimilar Candidate to Xolair (Omalizumab)
Shots: The US FDA has received a BLA for a biosimilar candidate to Novartis’ Xolair (omalizumab), developed by Kashiv BioSciences Additionally, Amneal expects to incur a $22.5M R&D milestone charge in Q3’25 instead of Q4 due to the earlier BLA filing & holds exclusive US commercialization rights for the product pending regulatory approval Xolair is…
3 days ago0Comments
Regeneron New
NEWS
Regeneron’s Evkeeza Receives the US FDA’s Approval to Treat Homozygous Familial Hypercholesterolemia in Younger Patients
Shots: The US FDA has approved label expansion to Evkeeza (evinacumab-dgnb) as an adj. to diet, exercise & other lipid-lowering therapies for the treatment of children (1 to <5yrs.) with homozygous familial hypercholesterolemia (HoFH) Approval was supported by efficacy & safety results in 6 children with HoFH (incl. PK data from 4) who participated in…
3 days ago0Comments
WEEKLY SNAPSHOT
PharmaShots Weekly Snapshots (Sep 22, 2025 – Sep 26, 2025)  
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A and Biosimilars. Check out our full report below:   Roche Reports P-III (evERA Breast Cancer) Trial Data on Giredestrant + Everolimus for ER-Positive Breast Cancer Read More: Roche BMS Reports the P-III (EXCALIBER-RRMM) Trial Data of Iberdomide Regimen to Treat…
September 26, 20250Comments