Alvotech and Teva Report the Regulatory Filing Acceptance for AVT06 (Biosimilar, Eylea) Across the US

Shots: The US FDA has accepted the BLA of AVT06 (2mg) for treating eye disorders, including diseases that can lead to vision loss or blindness. The regulatory approval process is expected to finish in Q4’25 AVT06/AVT29 is a recombinant fusion protein and biosimilar candidate to Eylea (aflibercept), targeting VEGF to inhibit receptor activation, neovascularization,…

ByRidhi RastogiFebruary 20, 2025

NEWS

The US FDA Accepts NDA of Boehringer Ingelheim’s Zongertinib for HER2 (ERBB2)-Mutant NSCLC

Shots: The US FDA has accepted & granted priority review to the NDA of zongertinib (BI 1810631) for the treatment of pts with inoperable or metastatic NSCLC harboring HER2 (ERBB2) mutations who have received prior systemic therapy (PDUFA: Q3’25) Submission was based on P-Ib (Beamion LUNG-1) trial assessing zongertinib as Monotx. in 2 arms…

ByRidhi RastogiFebruary 20, 2025

NEWS

CSPC Pharmaceutical Collaborates with Radiance Biopharma to Develop and Commercialize RB-164 (SYS6005) as an Anti-Cancer Therapy

Shots: CSPC has granted Radiance exclusive rights to develop & market RB-164 in the US, Canada, EU, UK, Switzerland, Norway, Iceland, Liechtenstein, Albania, Montenegro, North Macedonia, Serbia, & Australia, while retaining rights to other markets As per the deal, CSPC will get $15M upfront, ~$150M in development & regulatory milestones and ~$1B in commercial…

ByRidhi RastogiFebruary 20, 2025

NEWS

Epitopea Partners with Merck to Discover Cryptigen Tumor-Specific Antigens

Shots: Epitopea & Merck have entered into license & research collaboration agreement to discover Cryptigen tumor-specific antigens (TSAs) in an undisclosed solid tumor As per the deal, Epitopea will receive an undisclosed upfront & ~$300M in milestones per product in exchange for Merck receiving exclusive development & commercialization rights to the TSA products identified…

ByRidhi RastogiFebruary 20, 2025

NEWS

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

Ridhi Rastogi

Alvotech and Teva Report the Regulatory Filing Acceptance for AVT06 (Biosimilar, Eylea) Across the US

The US FDA Accepts NDA of Boehringer Ingelheim’s Zongertinib for HER2 (ERBB2)-Mutant NSCLC

CSPC Pharmaceutical Collaborates with Radiance Biopharma to Develop and Commercialize RB-164 (SYS6005) as an Anti-Cancer Therapy

Epitopea Partners with Merck to Discover Cryptigen Tumor-Specific Antigens

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

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