BMS Reports P-III (CheckMate-816) Trial Data of Opdivo as a Neoadjuvant Treatment of Resectable NSCLC

Shots: BMS has reported final data from P-III (CheckMate-816) trial of neoadj. Opdivo + Pt-doublet CT to treat adults with operable NSCLC (tumors ≥4cm or node positive) The P-III (CheckMate-816) trial evaluates Opdivo (360mg, Q3W for 3 cycles) + CT vs CT alone in 358 pts with resectable stage IB to IIIA NSCLC regardless…

ByRidhi RastogiFebruary 19, 2025

NEWS

Biogen Collaborates with Stoke Therapeutics to Develop and Commercialize Zorevunersen for Dravet Syndrome

Shots: Biogen & Stoke have partnered to develop & market zorevunersen for Dravet syndrome with Stoke retaining rights in the US, Canada, & Mexico while leading global development & Biogen securing marketing rights in other regions As per the deal, Stoke will get $165M upfront, ~$385M in development & commercial milestones, & net sales-based…

ByRidhi RastogiFebruary 19, 2025

NEWS

Celltrion Secures the EC’s Approval for Eydenzelt (Biosimilar, Eylea), Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

Shots: The EC has approved Eydenzelt (CT-P42, aflibercept), a biosimilar to Eylea, Stoboclo & Osenvelt (CT-P41, denosumab), a biosimilar to Prolia & Xgeva for all indications of the reference products The P-III trial of Eydenzelt (40 mg/mL solution for injection in a vial & pre-filled syringe) vs Eylea (aflibercept) in diabetic macular edema (DME)…

ByRidhi RastogiFebruary 19, 2025

NEWS

Gilead Reports US FDA’s NDA Acceptance of Lenacapavir for Pre-Exposure Prophylaxis (PreP) to Prevent HIV in Individuals at Risk

Shots: The US FDA has accepted & granted priority review to the NDA of lenacapavir (HIV-1 capsid inhibitor) for PreP in individuals at risk of HIV (PDUFA: Jun 19, 2025); MAA & EU-M4all application has been filed to the EMA NDA was based on P-III (PURPOSE 1 & PURPOSE 2) trials assessing lenacapavir (SC; twice…

ByRidhi RastogiFebruary 19, 2025

NEWS

Merus Receives the US FDA’s Breakthrough Therapy Designation for Petosemtamab to Treat 1L PD-L1+ Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

Shots: The US FDA has granted BTD to petosemtamab + Keytruda as 1L treatment of r/m HNSCC harboring PD-L1 (CPS ≥ 1) in adults BTD was backed by interim data from ongoing P-I/II trial evaluating petosemtamab + Keytruda in mentioned pts that showed 67% response rate in 24 evaluable pts with further data presented…

ByRidhi RastogiFebruary 19, 2025

NEWS

The US FDA Grants Breakthrough Therapy Designation to Innate Pharma’s Lacutamab for R/R Sézary Syndrome

Shots: The US FDA has granted BTD to lacutamab for the treatment of adults with r/r sézary syndrome after receiving ≥2L of therapy incl. mogamulizumab Designation was based on P-I as well as P-II (TELLOMAK) trial data, showing efficacy & favorable safety in pts who were heavily pre-treated with mogamulizumab Additionally, Lacutamab (anti-KIR3DL2…

ByRidhi RastogiFebruary 18, 2025

NEWS

Exelixis Presents 5-year Follow-Up Data from P-III (CheckMate -9ER) of Cabometyx + Opdivo in Renal Cell Carcinoma Patients at ASCO GU 2025

Shots: The P-III (CheckMate -9ER) trial assessed Cabometyx + Opdivo vs sunitinib in 651 pts with previously untreated advanced RCC At 67.6mos. mFU, study showed improved mPFS (16.4 vs 8.3mos.), OS (46.5 vs 35.5mos.), ORR (55.7% vs 27.4%) & DOR (22 vs 15.2mos.), while in IMDC risk groups: favorable (n=146; mPFS: 21.4 vs 12.8mos.; mOS:…

ByRidhi RastogiFebruary 18, 2025

NEWS

Regeneron and Sanofi Report the US FDA’s sBLA Acceptance for Dupixent to Treat Bullous Pemphigoid (BP)

Shots: The US FDA has accepted & granted priority review to the sBLA of Dupixent for the treatment of adults with BP (PDUFA: Jun 20, 2025) sBLA was supported by P-II/III (ADEPT) trial assessing Dupixent vs PBO in pts (n=106) for 52wks., that met its 1EP of 5x pts achieving sustained disease remission at…

ByRidhi RastogiFebruary 18, 2025

NEWS

The US FDA Approves MED-EL’s Sonnet 3 Audio Processor for Optimal Hearing

Shots: The US FDA has approved the Sonnet 3 audio processor for MED-EL cochlear implants; commercially available in early 2025. Also, Pts implanted with MED-EL as of Sep 1, 2024, can access one-time exchange for Sonnet 3 in the TechSwap Program Sonnet 3 is 2g lighter & ~18% shorter than Sonnet 2 with features…

ByRidhi RastogiFebruary 18, 2025

NEWS

Samsung Bioepis Reports the EC’s approval of Obodence & Xbryk (Biosimilar, Denosumab)

Shots: The EC has approved SB16: Obodence (60mg pre-filled syringe; Biosimilar: Prolia) & Xbryk (120mg vial; Biosimilar: Xgeva) for osteoporosis & prevention of skeletal related events, respectively Approval was based on the P-I trial which confirmed PK equivalence between SB16, EU-DEN & US-DEN among healthy males (n=168), in terms of AUC from time zero to…

ByRidhi RastogiFebruary 17, 2025

Ridhi Rastogi

BMS Reports P-III (CheckMate-816) Trial Data of Opdivo as a Neoadjuvant Treatment of Resectable NSCLC

Biogen Collaborates with Stoke Therapeutics to Develop and Commercialize Zorevunersen for Dravet Syndrome

Celltrion Secures the EC’s Approval for Eydenzelt (Biosimilar, Eylea), Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

Gilead Reports US FDA’s NDA Acceptance of Lenacapavir for Pre-Exposure Prophylaxis (PreP) to Prevent HIV in Individuals at Risk

Merus Receives the US FDA’s Breakthrough Therapy Designation for Petosemtamab to Treat 1L PD-L1+ Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

The US FDA Grants Breakthrough Therapy Designation to Innate Pharma’s Lacutamab for R/R Sézary Syndrome

Exelixis Presents 5-year Follow-Up Data from P-III (CheckMate -9ER) of Cabometyx + Opdivo in Renal Cell Carcinoma Patients at ASCO GU 2025

Regeneron and Sanofi Report the US FDA’s sBLA Acceptance for Dupixent to Treat Bullous Pemphigoid (BP)

The US FDA Approves MED-EL’s Sonnet 3 Audio Processor for Optimal Hearing

Samsung Bioepis Reports the EC’s approval of Obodence & Xbryk (Biosimilar, Denosumab)

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