Genentech Reports P-III (APHINITY) Trial Data of Perjeta Regimen for Early-Stage Breast Cancer

Shots:Genentech has reported 10yr. P-III (APHINITY) trial data assessing Perjeta + Herceptin & CT vs Herceptin + CT vs PBO as an adj. therapy in 4804 pts with operable HER2+ early-stage breast cancerAfter 10yrs, trial depicted improved OS, with 91.6% pts alive vs 89.8% on Herceptin + CT & PBO, with sustained invasive…

ByRidhi RastogiMay 13, 2025

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Novo Nordisk Reports P-III (REAL8) Basket Trial Data of Sogroya for Children with Growth Disorders

Shots:The P-III (REAL8) basket trial assessed Sogroya (0.24mg/kg, QW or 0.05 mg/kg, QD) in pre-pubertal children with NS, TS, or ISS; SGA-born children were randomized to Sogroya 0.24mg/kg QW or QD dosing (0.035 or 0.067mg/kg)Trial met its 1EP, showing QW dosing was non-inferior to GH therapy (QD) at Wk. 52, with superior HV…

ByRidhi RastogiMay 12, 2025

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Bayer Submits MAA of Eylea 8mg to Japan’s MHLW for Treating Macular Edema Secondary to Retinal Vein Occlusion (RVO)

Shots:Japan’s MHLW has received MAA for Eylea 8mg (114.3mg/ml for injection) to treat pts with macular edema following RVO (central, branch & hemiretinal) supported by the P-III (QUASAR) trial; regulatory filings are ongoing in other marketsIn the trial, Eylea 8mg (Q8W after 3 or 5 monthly doses) met its 1EP at 36wks. with…

ByRidhi RastogiMay 12, 2025

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LENZ Therapeutics Collaborates with Lotus Pharmaceutical to Commercialize LNZ100 in the Republic of Korea and Southeast Asia

Shots:LENZ has granted Lotus exclusive development, manufacturing, registration & marketing rights of LNZ100 to treat presbyopia in the Republic of Korea & certain Southeast Asian countries incl. Thailand, Philippines, Vietnam, Malaysia, Brunei, Indonesia & SingaporeAs per the deal, LENZ will obtain ~$125M in upfront, regulatory & commercial milestones, along with double-digit net sales-based…

ByRidhi RastogiMay 12, 2025

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AstraZeneca Reports P-III (POTOMAC) Trial Findings of Imfinzi Regimen for High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Shots:AstraZeneca has reported P-III (POTOMAC) trial findings assessing Imfinzi in 1018 high-risk, BCG-naïve NMIBC pts post-TURBT, randomized to Imfinzi + BCG induction & maintenance, Imfinzi + BCG induction-only, or SoC BCG therapyImfinzi + BCG induction & maintenance therapy showed improved disease-free survival (DFS; 1EP) vs SoC BCG, while Imfinzi + BCG induction-only did…

ByRidhi RastogiMay 12, 2025

News

ALK Reports Health Canada’s Approval of Itulatek to Treat Children and Adolescents with Allergic Rhinitis

Shots:Health Canada has approved Itulatek (tree pollen sublingual tablet) to treat mod. to sev. seasonal allergic rhinitis &/or conjunctivitis, induced by pollen from birch, alder, hazel, &/or oak in pts (5-17yrs.); applications under the Swissmedic & MHRA’s review, with decision expected this yearApproval was based on P-III (TT-06) trial assessing Itulatek vs PBO…

ByRidhi RastogiMay 9, 2025

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FDA Grants Verastem Oncology’s Avmapki + Fakzynja Accelerated Approval for KRAS-Mutated Low-Grade Serous Ovarian Cancer (LGSOC)

Shots:This accelerated approval for the combination of Avmapki (avutometinib) + Fakzynja (defactinib) was granted in advanced to the planned PDUFA of Jun 30, 2025 will be available in the US within a week as a co-pack.Approval was based on P-II (RAMP 201) trial assessing Avmapki (3.2mg, twice weekly) + Fakzynja (200mg, BID) in…

ByRidhi RastogiMay 9, 2025

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GSK Reports the P-III (GLISTEN) Study Results of Linerixibat for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Shots:GSK has reported P-III (GLISTEN) trial data assessing linerixibat (n=119) vs PBO (n=119) to treat PBC pts (N=238) with cholestatic pruritus; pts could switch to linerixibat in Part B of the trialTrial met its 1EP, showing significantly reduced itch per WI-NRS scale in PBC pts, as assessed by monthly itch score, over 24wks.…

ByRidhi RastogiMay 8, 2025

News

Amgen Reports the MHRA’s Approval of Tepezza to Treat Thyroid Eye Disease

Shots:UK’s MHRA has approved Tepezza (teprotumumab) for the treatment of adult pts with mod. to sev. thyroid eye disease (TED)Approval was based on extensive clinical data incl. P-III (OPTIC) trial (n=83), P-II (TED01RV) trial (n=88), P-IV (HZNP-TEP-403) trial (n=62) & P-III (OPTIC-J) trial in Japan (n=54)OPTIC trial showed that 83% (34/41) of…

ByRidhi RastogiMay 8, 2025

News

China’s NMPA Grants Full Approval to Everest Medicines’ Nefecon for the Treatment of Primary IgAN in Adults at Risk of Disease Progression

Shots:China’s NMPA has granted full approval to sNDA of Nefecon to reduce kidney function loss in adults with primary IgAN at risk of disease progression, regardless of their proteinuria levelsApproval was based on global P-III (NefIgArd) trial assessing Nefecon (16mg, QD, PO) vs PBO in above pts on RASi therapy over 2yrs. (9mos.…

ByRidhi RastogiMay 8, 2025

Genentech Reports P-III (APHINITY) Trial Data of Perjeta Regimen for Early-Stage Breast Cancer

Novo Nordisk Reports P-III (REAL8) Basket Trial Data of Sogroya for Children with Growth Disorders

Bayer Submits MAA of Eylea 8mg to Japan’s MHLW for Treating Macular Edema Secondary to Retinal Vein Occlusion (RVO)

LENZ Therapeutics Collaborates with Lotus Pharmaceutical to Commercialize LNZ100 in the Republic of Korea and Southeast Asia

AstraZeneca Reports P-III (POTOMAC) Trial Findings of Imfinzi Regimen for High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

ALK Reports Health Canada’s Approval of Itulatek to Treat Children and Adolescents with Allergic Rhinitis

FDA Grants Verastem Oncology’s Avmapki + Fakzynja Accelerated Approval for KRAS-Mutated Low-Grade Serous Ovarian Cancer (LGSOC)

GSK Reports the P-III (GLISTEN) Study Results of Linerixibat for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Amgen Reports the MHRA’s Approval of Tepezza to Treat Thyroid Eye Disease

China’s NMPA Grants Full Approval to Everest Medicines’ Nefecon for the Treatment of Primary IgAN in Adults at Risk of Disease Progression

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