Johnson & Johnson Submits NDA to the US FDA for Icotrokinra to Treat Plaque Psoriasis (PsO)

Shots: The US FDA has received NDA of icotrokinra for the treatment of pts (≥12yrs.) with mod. to sev. plaque PsO NDA 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 RastogiJuly 22, 2025

NEWS

Bayer Reports EC’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The EC has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) ± docetaxel to treat mHSPC pts Approval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT vs PBO + ADT in 669 mHSPC pts Trial showed a 46% reduction in rPFS (1EP), with consistent benefit observed across all subgroups, incl. pts…

ByRidhi RastogiJuly 21, 2025

NEWS

Autolus Therapeutics’ Aucatzyl Secures the EC’s Approval for R/R B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Shots: The EC has approved Aucatzyl (Obecabtagene Autoleucel) for treating pts (≥26yrs.) with r/r B-ALL in all 30 EEA states The EC approval was based on the FELIX study (n=100+), which showed that pts in cohort IIA (n=94) receiving ≥1 infusion of obe-cel had a 76.6% CR/CRi rate, with a mDoR of 21.2mos. & mEFS…

ByDipanshu DixitJuly 21, 2025

NEWS

ARS Pharmaceuticals and ALK’s EURneffy Secures the MHRA’s Approval to Treat Allergic Reactions in Children

Shots: The UK’s MHRA has approved EURneffy 2mg (adrenaline nasal spray) to treat allergic reactions (anaphylaxis) in children (>30kg); commercially available in the UK by late Q3’25 In Nov 2024, ARS Pharma granted ALK exclusive rights to commercialize neffy outside the US, incl. EU (as EURneffy), Canada, & select markets in exchange for $145M upfront, ~$320M…

ByRidhi RastogiJuly 21, 2025

NEWS

The EC Grants Conditional Approval to SpringWorks Therapeutics’ Ezmekly for NF1-PN

Shots: The EC has granted conditional approval to Ezmekly (mirdametinib) for pts (≥2yrs.) with unresectable neurofibromatosis type 1 associated symptomatic plexiform neurofibromas (NF1-PN) based on P-IIb (ReNeu) trial The P-IIb (ReNeu) study assessed mirdametinib (2mg/m^2, BID) in 2 Arms (N=114: 56 pediatric & 58 adults) & met its 1EP of cORR (52% & 41%) with durable…

ByRidhi RastogiJuly 21, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jul 14, 2025 – Jul 18, 2025)   

This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, M&A, DigiHealth and Biosimilars. Check out our full report below: Takeda Reports P-III (FirstLight & RadiantLight) Trials Data on Oveporexton for Narcolepsy Type 1 (NT1) Read More: Takeda AstraZeneca Reports P-III (BaxHTN) Trial Results of Baxdrostat for Uncontrolled or Treatment Resistant…

ByRidhi RastogiJuly 18, 2025

NEWS

Rocket Pharmaceuticals Receives the US FDA’s RMAT Designation of RP-A601 to Treat PKP2-Arrhythmogenic Cardiomyopathy

Shots: The US FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-A601 for the treatment of PKP2-arrhythmogenic cardiomyopathy Designation was supported by ongoing P-I trial, where all 3 adults treated with a single dose of RP-A601 (8x10¹³ GC/kg) showed enhanced PKP2 protein expression, incl. 110% & 398% increase in 2 pts with low…

ByRidhi RastogiJuly 18, 2025

NEWS

Daiichi Sankyo Receives the US FDA’s Breakthrough Therapy Designation for Enhertu + Perjeta to Treat HER2+ Breast Cancer

Shots: The US FDA has granted BTD to Enhertu + Perjeta for the 1L treatment of adults with unresectable or metastatic HER2+ breast cancer Designation was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta (THP) in HER2+ metastatic breast cancer pts (n=1157) Trial showed improved PFS by 44% (mPFS: 40.7…

ByRidhi RastogiJuly 18, 2025

NEWS

The US FDA Grants Priority Review to Johnson & Johnson’s TAR-200 for BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)

Shots: The US FDA has granted priority review to NDA of TAR-200 for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive HR-NMIBC with CIS &/or papillary tumors NDA was supported by the P-IIb (SunRISe-1) trial, assessing TAR-200 in pts ineligible or opting out of radical cystectomy that showed an 82.4% CR rate & 52.9% remained cancer-free for at…

ByRidhi RastogiJuly 18, 2025

NEWS

The US FDA Approves GSK’s Shingrix Prefilled Syringe Presentation to Protect Individuals Against Shingles

Shots: The US FDA has approved prefilled syringe formulation of Shingrix (Recombinant Zoster Vaccine) for the prevention of shingles (herpes zoster) Approval was supported by data demonstrating its technical comparability to the existing format, which incl. 2 separate vials, a lyophilised antigen & a liquid adjuvant, combined by healthcare professionals before use Additionally, Shingrix prefilled…

ByRidhi RastogiJuly 17, 2025

Johnson & Johnson Submits NDA to the US FDA for Icotrokinra to Treat Plaque Psoriasis (PsO)

Bayer Reports EC’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Autolus Therapeutics’ Aucatzyl Secures the EC’s Approval for R/R B-Cell Acute Lymphoblastic Leukemia (B-ALL)

ARS Pharmaceuticals and ALK’s EURneffy Secures the MHRA’s Approval to Treat Allergic Reactions in Children

The EC Grants Conditional Approval to SpringWorks Therapeutics’ Ezmekly for NF1-PN

PharmaShots Weekly Snapshots (Jul 14, 2025 – Jul 18, 2025)

Rocket Pharmaceuticals Receives the US FDA’s RMAT Designation of RP-A601 to Treat PKP2-Arrhythmogenic Cardiomyopathy

Daiichi Sankyo Receives the US FDA’s Breakthrough Therapy Designation for Enhertu + Perjeta to Treat HER2+ Breast Cancer

The US FDA Grants Priority Review to Johnson & Johnson’s TAR-200 for BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)

The US FDA Approves GSK’s Shingrix Prefilled Syringe Presentation to Protect Individuals Against Shingles

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