We are now halfway through 2025, and it’s not too late to highlight the practices and trends that are shaping and will continue to shape the biopharma landscape this year. In 2024, we navigated the 4 biopharma trends that exerted vehement force in the industry and shaped the course of healthcare practices. Last year, the…
Shots:
TRIUMpH program consisted of 2 P-III trials assessing tegoprazan in US GERD pts with erosive esophagitis (EE; n=1250 incl. 463 with LA Grade C/D esophagitis) & non-erosive reflux disease (NERD; n=800); FDA’s NDA filing for both EE & NERD is planned in Q4’25
In EE pts, tegoprazan (100 & 50mg) met the 1EP, showing…
Shots:
TransMedics received US FDA conditional IDE approval to initiate its two-part Next‑Gen OCS ENHANCE Heart study evaluating prolonged heart perfusion (Part A) and superiority of OCS Heart in donation after brain death (DBD) cases vs static cold storage (Part B)
The study will enroll >650 pts; Part B aims to expand OCS Heart indications…
This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, M&A, and Biosimilars. Check out our full report below: 
PulseSight Therapeutics Reports First Patient Dosing with PST-611 in P-I (PST-611-CT1) Trial for Dry AMD/Geographic Atrophy 
Read More: PulseSight Therapeutics
BioAtla Presents Preliminary P-I Trial Data of BA3182 in Patients with…
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…
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)Â
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 endpointsÂ
Rinvoq…
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:   Â
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)…
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…
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.…
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…

