R AML

Shots: Moleculin received approval from Georgia’s RAMPA to initiate its global P-IIb/III (MIRACLE) study of AnnAraC (Annamycin + cytarabine) in R/R AML, and first pt dosing expected by Aug-end; CTA already approved in EU The study includes adaptive design; Part A will randomize 75-90 pts (1:1:1) to HiDAC + PBO or Annamycin (190 or 230…

ByDipanshu DixitJuly 11, 2025

VIEWPOINTS

Unlocking Approval: Sofie Berg from AbbVie in a Riveting Conversation with PharmaShots

Shots: AbbVie adds an eighth indication to Rinvoq’s label with the European Commission’s approval for treating adult patients with giant cell arteritis (GCA) Sofie Berg, Therapeutic Area Head of International Immunology at AbbVie, in a conversation with PharmaShots, shares insights from the SELECT-GCA trial evaluating Rinvoq in GCA, highlighting both primary and secondary endpoints Rinvoq…

BySaurabh ChaubeyJuly 9, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jun 23, 2025 – Jun 27, 2025)  

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, and Animal Health. Check out our full report below:   Teva Reports the Data from the P-IV (PEARL) Study of Ajovy (fremanezumab) for Chronic and Episodic Migraine Prevention Read More: Teva Merck Reports the Data from P-III (HYPERION)…

ByDipanshu DixitJune 27, 2025

NEWS

Verastem Oncology Reports First Patient Dosing with VS-7375 in P-I/IIa Study for KRAS G12D Advanced Solid Tumors

Shots: Verastem reported the dosing of the first patient (US) for P-I/IIa study (VS-7375-101) assessing the safety, tolerability, and efficacy of VS-7375 The dose-escalation phase of the study starts at 400mg, based on results from a P-I/II study conducted by GenFleet in China, and presented initial safety and efficacy data at ASCO’25 Upon reaching the…

ByPrince GiriJune 25, 2025

MAGAZINE

PharmaShots Magazine-June-2025 Edition

Decentralized Clinical Trials (DCTs) colloquially known as hybrid trials were popularized during COVID-19. With the changing healthcare landscape, trial sponsors are looking for practices that are feasible and cost-effective. DCTs offer holistic solutions to mitigate the gaps in traditional clinical trial models by integrating emerging technologies and gadgets into the nuanced aspects of data capturing.…

ByAditya SinghJune 12, 2025

NEWS

Regeneron Highlights Dupixent (dupilumab) Data From P-IV (DISCOVER) Study at RAD’25

Shots : Regeneron highlighted the data at RAD’25 from the P-IV (DISCOVER) study evaluating Dupixent in pts (N=120) with atopic dermatitis with skin of color that received Dupixent as monotx. Q2W based on weight after loading dose: 200mg for 30-60kg pts & 300mg for ≥60kg pts Dupixent achieved a ≥75% improvement in overall disease severity…

ByPrince GiriJune 10, 2025

VIEWPOINTS

Takeda at ASH 2024: Phuong Khanh Morrow from Takeda in a Riveting Conversation with PharmaShots

Shots: Recently, at ASH 2024, Takeda presented data from several ongoing clinical trials across hematology and oncology, including the Phase II OPTIC and Phase III PhALLCON studies, among others Phuong Khanh Morrow, Head of the Oncology Therapeutic Area Unit at Takeda, shed light on Takeda’s key presentations at ASH 2024 Phuong also highlighted the findings…

BySaurabh ChaubeyJune 2, 2025

NEWS

KaliVir Immunotherapeutics Reports Completion of First Cohort of P-I/Ib (STEALTH-001) Study in Advanced Solid Tumors

Shots: KaliVir Immunotherapeuticsreported completion of the first cohort in P-I/Ib (STEALTH-001) study evaluating VET3-TGI as a monotx. and in combination with a checkpoint inhibitor in advanced, unresectable, or metastatic solid tumor pts. The Data Safety Committee reviewed initial safety data and approved the progression of VET3-TGI to the next IT and IV dosing cohorts VET3-TGI is an…

ByPrince GiriMay 21, 2025

NEWS

Viridian Therapeutics Releases the Long-Term Durability Data Evaluating Veligrotug in P-III (THRIVE) Study in Active TED

Shots: Viridian reported positive long-term durability data from the P-III (THRIVE) study evaluating 5 infusions of veligrotug (veli) or PBO (Q3W), with primary topline analysis at 15wks and follow-up to 52wks, in active thyroid eye disease (TED) pts. (N=30) Study demonstrated that 70% (21/30) were proptosis responders at 15wks. and maintained at least a 2…

ByPrince GiriMay 21, 2025

NEWS

ArkBio Reports P-II Study Data Evaluating AK3280 to Treat Idiopathic Pulmonary Fibrosis (IPF)

Shots: ArkBio has reported positive top-line data from the P-II study conducted across 31 clinical sites in China to evaluate safety, tolerability, and clinical efficacy of AK3280 in IPF pts Pts who received AK3280 (100/200/300/400mg BID) demonstrated 209.4 mL increase in forced vital capacity (FVC) and a 6.4% adjusted improvement in %pFVC from baseline and…

ByPrince GiriMay 16, 2025

Moleculin Receives RAMPA’s CTA Approval for P-IIb/III (MIRACLE) Study of AnnAraC in R/R AML

Unlocking Approval: Sofie Berg from AbbVie in a Riveting Conversation with PharmaShots

PharmaShots Weekly Snapshots (Jun 23, 2025 – Jun 27, 2025)

Verastem Oncology Reports First Patient Dosing with VS-7375 in P-I/IIa Study for KRAS G12D Advanced Solid Tumors

PharmaShots Magazine-June-2025 Edition

Regeneron Highlights Dupixent (dupilumab) Data From P-IV (DISCOVER) Study at RAD’25

Takeda at ASH 2024: Phuong Khanh Morrow from Takeda in a Riveting Conversation with PharmaShots

KaliVir Immunotherapeutics Reports Completion of First Cohort of P-I/Ib (STEALTH-001) Study in Advanced Solid Tumors

Viridian Therapeutics Releases the Long-Term Durability Data Evaluating Veligrotug in P-III (THRIVE) Study in Active TED

ArkBio Reports P-II Study Data Evaluating AK3280 to Treat Idiopathic Pulmonary Fibrosis (IPF)

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