All articles by Manish Kumar
Manish Kumar
US FDA approves AstraZeneca’s Fasenra for adults with EGPA
The FDA approved Fasenra based on the MANDARA Phase 3 trial, which showed comparable efficacy to mepolizumab and a similar safety profile for treating EGPA
GSK reports positive results from Arexvy/Shingrix co-administration trial
The trial met its primary endpoint, showing non-inferior immune responses for co-administered RSV and shingles vaccines, which were well tolerated with acceptable reactogenicity and safety profiles
Lilly to invest $1.8bn to expand manufacturing footprint in Ireland
Eli Lilly boosts Limerick investment by $1bn and unveils an $800m Kinsale facility to enhance global medicine production and benefit patients worldwide
China’s NMPA approves Keymed’s Stapokibart for atopic dermatitis
The marketing approval is based on results from a Phase 3 study announced in June that showed that Stapokibart demonstrated sustained efficacy and a favourable safety profile
GSK announces positive headline data from Phase 2 seasonal influenza mRNA vaccine programme
A vaccine candidate formulation demonstrated positive A and B strain immune responses relative to standard of care in both younger and older adults
Merck’s Gardasil 9 vaccine meets primary endpoint in Phase 3 trial
The trial met all endpoints, showing that a three-dose regimen of Gardasil 9 significantly reduced persistent anogenital infections from nine HPV types compared to placebo
Sanofi’s Dupixent improves itch and hives in Phase 3 CSU trial
Dupixent showed a significant improvement over placebo, along with greater reduction in itch severity and reduction in urticaria activity severity at 24 weeks
Allergan Aesthetics launches BOTOX Cosmetic for MMP in adults in China
Approval supported by well-established safety profile and robust clinical trials demonstrating BOTOX Cosmetic is effective in reducing the prominence of the masseter muscle
FUJIFILM Cellular Dynamics unveils iCell Sensory Neurons
The iCell Sensory Neurons are ready-to-use, human iPSC-derived models that display key drug discovery targets for nociception through expression and function, making them ideal for drug discovery research
Lilly’s efsitora meets primary endpoint in Phase 3 type 1 diabetes trial
The trial showed efsitora achieved non-inferior A1C reduction with a 0.53% decrease, compared to 0.59% for insulin degludec at week 26