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Daiichi Sankyo and Merck Report the P-II Study Data for Raludotatug Deruxtecan in Pt.-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Shots: Daiichi Sankyo and Merck reported efficacy results for raludotatug deruxtecan (R-DXd) in patients with recurrent Pt.-resistant ovarian, primary peritoneal, or fallopian tube cancer from the P-II (dose-optimization) part of the REJOICE-Ovarian01 P-II/III study Across all doses (4.8 mg/kg, 5.6 mg/kg, and 6.4 mg/kg), ORR was 50.5% (n=107) as assessed by BICR, with 3 complete…
October 21, 2025
Celltrion
FDA Approves Celltrion’s Yuflyma (Biosimilar, Humira) and its Unbranded Version for Hidradenitis Suppurativa (HS) and Uveitis in Younger Patients
Shots: The US FDA has approved Yuflyma, a biosimilar version of Humira (adalimumab) & its unbranded version for the treatment of HS in adolescents (≥12yrs.), & uveitis in children (≥2yrs.) Yuflyma, an anti-TNFα mAb, was previously approved by the FDA for rheumatoid & psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, &…
October 17, 2025
Johnson& Johnson
Johnson & Johnson Reports the US FDA’s sNDA Acceptance & Priority Review of Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Shots: The US FDA has accepted sNDA & granted priority review to Akeega (niraparib & abiraterone acetate tablet) + prednisone to treat adults with BRCA-mutated mHSPC sNDA was backed by P-III (AMPLITUDE) trial assessing Akeega + prednisone/prednisolone + ADT vs PBO/abiraterone acetate with prednisone + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mHSPC…
October 17, 2025
EVOQ Therapeutics Signs a ~$500M Deal with Sanofi for NanoDisc Technology
Shots: EVOQ Therapeutics has entered into a collaboration & license agreement with Sanofi to advance EVOQ’s NanoDisc tech in immunology As per the deal, both companies will jointly lead research activities, with Sanofi responsible for global development & commercialization efforts. In exchange, EVOQ will receive over $500M, incl. upfront, preclinical, development & sales milestones, with tiered…
October 17, 2025
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