All articles by Manish Kumar
Manish Kumar
Merck’s Phase 3 trial of SC pembrolizumab in NSCLC meets primary PK endpoints
The trial featured 378 patients, who were randomised in a 2:1 ratio to receive either SC pembrolizumab with chemotherapy or IV Keytruda with chemotherapy
Pharmanovia licenses Lindis’ catumaxomab for malignant ascites treatment
Catumaxomab, branded as Korjuny, is set for EU approval as the first cancer-targeted treatment for malignant ascites after a positive CHMP opinion in October this year
Linerixibat shows positive Phase 3 results in cholestatic pruritus in primary biliary cholangitis
Primary endpoint met with a statistically significant improvement in itch over 24 weeks compared with placebo
J&J’s icotrokinra meets co-primary endpoints in Phase 3 plaque psoriasis trial
Icotrokinra demonstrated significant skin clearance in moderate-to-severe plaque psoriasis, meeting co-primary endpoints at week 16, with continued improvement through week 24
Lilly’s Lp(a) targeting candidate muvalaplin meets primary endpoint in Phase 2 trial
The study demonstrated that the highest dose of muvalaplin significantly reduced elevated Lp(a) levels in adults, achieving its primary endpoint of Lp(a) reduction at week 12
Tagrisso recommended for approval in the EU by CHMP for patients with unresectable EGFR-mutated lung cancer
Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years
BMS gets positive CHMP opinion for Opdivo in colorectal cancer treatment
The opinion was based on results from the CheckMate -8HW trial in which Opdivo plus Yervoy showed a 79% reduction in the risk of disease progression or death compared to chemotherapy
Sandoz secures EC marketing nod for Eylea biosimilar Afqlir
Afqlir, a biosimilar to Eylea, is approved for treating retinal diseases, including neovascular age-related macular degeneration, to help prevent vision loss and blindness
Acepodia announces FDA clearance of investigational new drug application for ACE1831 in IgG4-related disease
ACE1831 is an allogeneic gamma delta T cell therapy candidate targeting CD20-expressing cells currently being investigated in non-Hodgkin’s lymphoma (NHL)
Halozyme offers €11 per share to acquire Evotec for €2bn
The proposed acquisition of Evotec aims to merge drug delivery and discovery technologies, creating a global company with a robust pipeline and advanced capabilities