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

News

Sebela Pharmaceuticals Reports Topline P-III (TRIUMpH) Program Data of Tegoprazan for Gastroesophageal Reflux Disease (GERD)

Shots: TRIUMpH program consists of 2 P-III trials assessing tegoprazan in US GERD pts with erosive esophagitis (EE) & non-erosive reflux disease (NERD); EE’s maintenance phase to end by Q3’25, with FDA’s NDA filing for both EE & NERD planned in Q4’25 EE study (vs lansoprazole) in 1250 pts (incl. 463 with LA Grade C/D)…

ByRidhi RastogiApril 24, 2025

INSIGHTS+

PharmaShots’ Key Highlights of First Quarter 2025

Shots:  Q1’2025 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The talk of the town remained Intra-Cellular Therapies’ acquisition by Johnson & Johnson for ~$14.6B The quarter highlighted breakthrough results, pivotal clinical data, including Eli Lilly and Incyte's P-III Study Data of Baricitinib to treat Alopecia Areata PharmaShots brings…

ByRidhi RastogiApril 1, 2025

News

Incyte Reports Topline Data from P-III (STOP-HS1 & STOP-HS2) Trials of Povorcitinib (INCB054707) for Hidradenitis Suppurativa (HS)

Shots: The 2 P-III (STOP-HS1 & STOP-HS2) trials assessed povorcitinib (45 or 75mg, QD, PO) vs PBO in mod. to sev. HS pts (≥18yrs.; n=600 each) for 12wks., followed by 42wk. extension & 30-day follow-up STOP-HS1 met its 1EP, with povorcitinib (45 mg/75 mg) showing higher HiSCR50 rates at Wk. 12 (40.2%/40.6% vs 29.7%), while…

ByRidhi RastogiMarch 18, 2025

News

Merck Reports P-III (MK-8591A-052 & MK-8591A-051) Trial Data of Doravirine + Islatravir (DOR/ISL) for HIV-1 Infection in Adults

Shots: Merck has reported 2 P-III (MK-8591A-052 & MK-8591A-051) trial data assessing DOR/ISL (100mg/0.25mg, QD, PO) in HIV-1 infected adults; MAA submission to begin by mid-2025 MK-8591A-052 assessed it vs BIC/FTC/TAF (50mg/200mg/25mg) in adults (n=513), meeting its 1EP with 1.5% subjects on DOR/ISL having a viral load ≥50 copies/mL vs 0.6% at 48wks. It…

ByRidhi RastogiMarch 13, 2025

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)

Sebela Pharmaceuticals Reports Topline P-III (TRIUMpH) Program Data of Tegoprazan for Gastroesophageal Reflux Disease (GERD)

PharmaShots’ Key Highlights of First Quarter 2025

Incyte Reports Topline Data from P-III (STOP-HS1 & STOP-HS2) Trials of Povorcitinib (INCB054707) for Hidradenitis Suppurativa (HS)

Merck Reports P-III (MK-8591A-052 & MK-8591A-051) Trial Data of Doravirine + Islatravir (DOR/ISL) for HIV-1 Infection in Adults

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