MavriX Bio Reports the US FDA’s IND Clearance of MVX-220 for Angelman Syndrome

Shots: The US FDA has approved IND application of MVX-220 for the treatment of Angelman Syndrome (AS) to initiate P-I/II (ASCEND-AS) trial, with first pts dosing expected in H2’25 The P-I/II trial will evaluate the safety, tolerability, & effectiveness of MVX-220 in both adult & pediatric pts with multiple AS genotypes, incl. rare types like uniparental…

ByRidhi RastogiMay 13, 2025

NEWS

UK’s MHRA Approves AstraZeneca’s Trixeo Aerosphere with Near-Zero GWP Propellant for Chronic Obstructive Pulmonary Disease (COPD)

Shots: The UK’s MHRA has approved Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF) with HFO-1234ze(E), a next-generation, near-zero global warming potential (GWP) propellant for treating COPD in adults; regulatory review is ongoing in EU, China & other regions Approval was based on a next-generation propellant clinical development program assessing Trixeo + HFO-1234ze(E) vs Trixeo + HFA-134a,…

ByRidhi RastogiMay 13, 2025

NEWS

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

NEWS

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 markets In the trial, Eylea 8mg (Q8W after 3 or 5 monthly doses) met its 1EP at 36wks. with…

ByRidhi RastogiMay 12, 2025

NEWS

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 & Singapore As per the deal, LENZ will obtain ~$125M in upfront, regulatory & commercial milestones, along with double-digit net sales-based…

ByRidhi RastogiMay 12, 2025

NEWS

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 therapy Imfinzi + 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

Teal Health Reports the US FDA’s Approval of Teal Wand for Cervical Cancer Screening

Shots: The US FDA has approved Teal Wand to screen cervical cancer at-home for women (25-65yrs.); commercially available in California by Jun 2025, with further expansion worldwide Approval was based on SELF-CERV study, which showed Teal Wand detected cervical precancer 96% of the time, with 94% participants preferring at-home screening test if it was as…

ByRidhi RastogiMay 12, 2025

NEWS

Johnson & Johnson Reveals P-III (ICONIC-TOTAL) Trial Data of Icotrokinra for Plaque Psoriasis

Shots: J&J has reported P-III (ICONIC-TOTAL) trial data assessing icotrokinra (QD, PO; n=208) vs PBO (n=103) in 311 PsO pts (≥12yrs.) with ≥1% body surface area & at least mod. plaque PsO at high-impact sites At Wk. 16, trial met its 1EP, with 57% vs 6% achieving IGA 0/1 & ≥2-grade improvement while in scalp…

ByRidhi RastogiMay 12, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (May 05, 2025 – May 09, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, Biosimilar & Animal Health. Check out our full report below: Recursion Presents Preliminary P-Ib/II (TUPELO) Trial Data of REC-4881 for Familial Adenomatous Polyposis (FAP) at DDW 2025 Read More: Recursion Chengdu Origen and Vanotech Report the First Patient Dosing in P-I (VAN-2401)…

ByRidhi RastogiMay 9, 2025

NEWS

UTR Therapeutics Seeks the US FDA’s IND Clearance of UTRxM1-18 to Target c-MYC-Driven Cancers

Shots: The US FDA has received the IND application for UTRxM1-18, a novel therapy targeting c-MYC-driven cancers, to initiate P-I trial in 2026 pending approval, focusing on c-MYC driven tumors incl. triple-negative breast, pancreatic, colorectal, & ovarian cancer UTRxM1-18 has demonstrated strong, dose-dependent efficacy against human-derived tumors from multiple cancer subtypes, with no dose-limiting toxicities…

ByRidhi RastogiMay 9, 2025

Ridhi Rastogi

MavriX Bio Reports the US FDA’s IND Clearance of MVX-220 for Angelman Syndrome

UK’s MHRA Approves AstraZeneca’s Trixeo Aerosphere with Near-Zero GWP Propellant for Chronic Obstructive Pulmonary Disease (COPD)

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)

Teal Health Reports the US FDA’s Approval of Teal Wand for Cervical Cancer Screening

Johnson & Johnson Reveals P-III (ICONIC-TOTAL) Trial Data of Icotrokinra for Plaque Psoriasis

PharmaShots Weekly Snapshots (May 05, 2025 – May 09, 2025)

UTR Therapeutics Seeks the US FDA’s IND Clearance of UTRxM1-18 to Target c-MYC-Driven Cancers

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