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)…
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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…
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.…
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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…
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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…
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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…
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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…
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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…
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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)…
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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…

