Novocure Reports MHLW’s Approval of Optune Lua for NSCLC

Shots: Approval of Optune Lua for adults with unresectable advanced/recurrent NSCLC who progressed on Pt-based regimen, was based on P-III (LUNAR) trial assessing it with PD-1/PD-L1 inhibitors or docetaxel (n=145) vs PD-1/PD-L1 inhibitors or docetaxel alone (n=146) Trial showed an mOS (1EP) of 13.2 vs 9.9mos. in the overall population, 19 vs 10.8mos. with Optune Lua +…

ByRidhi RastogiSeptember 16, 2025

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Ocugen Joins Forces with Kwangdong Pharmaceutical for OCU400 to Treat Retinitis Pigmentosa

Shots: Ocugen has entered into a licensing agreement with Kwangdong Pharmaceutical for OCU400 to treat retinitis pigmentosa As per the deal, Kwangdong will receive exclusive Korean rights to OCU400 in exchange for $7.5M in upfront & near-term milestones, $1.5M per $15M in sales, reaching ≥$180M in sales milestones, plus 25% royalties on net sales, while…

ByRidhi RastogiSeptember 15, 2025

NEWS

Akeso Reports First Patient Dosing in P-II (COMPASSION-36) Trial of Cadonilimab for PD-1 Treatment-Resistant Hepatocellular Carcinoma (HCC)

Shots: Akeso has dosed its first patient with cadonilimab + lenvatinib in P-II (COMPASSION-36/AK104-225) trial against lenvatinib for the treatment of advanced HCC in pts previously treated with Tecentriq & Avastin; study is ongoing in the US, EU & China Cadonilimab has also shown superior efficacy in combination regimens, incl. 100% DCR with FOLFOX-HAIC in resectable multinodular HCC…

ByRidhi RastogiSeptember 15, 2025

NEWS

Ionis’ ION582 Receives the US FDA’s Breakthrough Therapy Designation to Treat Angelman Syndrome

Shots: The US FDA has granted BTD to ION582 (UBE3A protein expression stimulant) for the treatment of Angelman syndrome Designation was based on P-I/II (HALOS) trial assessing ION582 in pts with Angelman syndrome, which showed improvements across all functional domains incl. communication, cognition & motor function; safety was favorable Additionally, ION582 is being investigated in…

ByRidhi RastogiSeptember 12, 2025

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Johnson & Johnson Reports the EMA’s MAA Submission of Icotrokinra to Treat Plaque Psoriasis (PsO)

Shots: The EMA has received MAA of icotrokinra (QD) for the treatment of pts (≥12yrs.) with mod. to sev. plaque PsO MAA was backed by P-III (ICONIC-TOTAL, ICONIC LEAD, ICONIC-ADVANCE 1 & 2) trials, where ICONIC-LEAD (vs PBO) met its co-1EPs of IGA 0/1 & PASI 90 at Wk. 16, plus showed higher rates of clear or almost clear…

ByRidhi RastogiSeptember 12, 2025

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Merck Reports P-III (STRIDE-13) Trial of Capvaxive for Active Immunization Against Pneumococcal Disease

Shots: Merck has reported P-III (STRIDE-13) trial evaluating Capvaxive (21-valent pneumococcal conjugate vaccine) vs PPSV23 in pts (n=882; 2 to <18yrs.) with prior pediatric pneumococcal vaccination & chronic conditions increasing pneumococcal disease risk Trial showed that Capvaxive induced immune responses to all 21 serotypes per opsonophagocytic activity (OPA) geometric mean titers (2EP), plus was noninferior…

ByRidhi RastogiSeptember 11, 2025

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Regeneron Reports Follow-Up Data from P-III (EMPOWER-Lung 3) Trial of Libtayo (Cemiplimab) to Treat NSCLC

Shots: The P-III (EMPOWER-Lung 3) trial assessed Libtayo (350mg, Q3W for 108wks.; n=312) vs PBO (n=154), both with Pt-based CT (Q3W ×4 cycles), in 466 adults with LA/M NSCLC harboring no EGFR, ALK, or ROS1 alteration At mFU of 60.9mos., trial showed a 34% reduction in death risk (mOS: 21.1 vs 12.9mos.; 5yr. survival probability:…

ByRidhi RastogiSeptember 11, 2025

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Corcept Therapeutics Reports the US FDA’s NDA Acceptance of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

Shots: The US FDA has accepted NDA of relacorilant for the treatment of Pt-resistant ovarian cancer (PDUFA: Jul 11, 2026) NDA was supported by P-III (ROSELLA) & P-II trials, where relacorilant + nab-paclitaxel demonstrated improved PFS & OS compared to nab-paclitaxel monotx., with no need for biomarker selection & favorable safety Additionally, relacorilant (GR antagonist)…

ByRidhi RastogiSeptember 11, 2025

NEWS

Sobi Reports the US FDA’s BLA Acceptance of Nanoecapsulated Sirolimus + Pegadricase for Uncontrolled Gout

Shots: The US FDA has accepted the BLA of Nanoecapsulated Sirolimus + Pegadricase (NASP; Q4W) for the treatment of uncontrolled gout (PDUFA: Jun 27, 2026) BLA was supported by P-III (DISSOLVE I & II) trials evaluating 2 NASP doses vs PBO in adults with uncontrolled gout, which met its 1EP of sustained decrease in serum…

ByRidhi RastogiSeptember 10, 2025

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Medison and Ipsen’s Bylvay Receives the Health Canada’s Approval to Treat Cholestatic Pruritus in Alagille Syndrome Patients

Shots: Health Canada has approved Bylvay (odevixibat) for the treatment of cholestatic pruritus in pts (≥12mos.) with Alagille Syndrome (ALGS) Approval was based on P-III (ASSERT) trial assessing Bylvay (120µg/kg, QD) vs PBO in ALGS pts for 24wks. across North America, EU, Middle East, & Asia Pacific regions Trial met its 1EP of improved pruritus…

ByRidhi RastogiSeptember 10, 2025

Novocure Reports MHLW’s Approval of Optune Lua for NSCLC

Ocugen Joins Forces with Kwangdong Pharmaceutical for OCU400 to Treat Retinitis Pigmentosa

Akeso Reports First Patient Dosing in P-II (COMPASSION-36) Trial of Cadonilimab for PD-1 Treatment-Resistant Hepatocellular Carcinoma (HCC)

Ionis’ ION582 Receives the US FDA’s Breakthrough Therapy Designation to Treat Angelman Syndrome

Johnson & Johnson Reports the EMA’s MAA Submission of Icotrokinra to Treat Plaque Psoriasis (PsO)

Merck Reports P-III (STRIDE-13) Trial of Capvaxive for Active Immunization Against Pneumococcal Disease

Regeneron Reports Follow-Up Data from P-III (EMPOWER-Lung 3) Trial of Libtayo (Cemiplimab) to Treat NSCLC

Corcept Therapeutics Reports the US FDA’s NDA Acceptance of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

Sobi Reports the US FDA’s BLA Acceptance of Nanoecapsulated Sirolimus + Pegadricase for Uncontrolled Gout

Medison and Ipsen’s Bylvay Receives the Health Canada’s Approval to Treat Cholestatic Pruritus in Alagille Syndrome Patients

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