This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, M&A, DigiHealth and Biosimilars. Check out our full report below:
Takeda Reports P-III (FirstLight & RadiantLight) Trials Data on Oveporexton for Narcolepsy Type 1 (NT1)
Read More: Takeda
AstraZeneca Reports P-III (BaxHTN) Trial Results of Baxdrostat for Uncontrolled or Treatment Resistant Hypertension
Read More: AstraZeneca
Merck Advances MK-8527 in P-III (EXPrESSIVE) Trials to Prevent HIV in Individuals at Risk
Read More: Merck
AstraZeneca Reports P-III (CARES) Trial Findings on Anselamimab for Light Chain Amyloidosis
Read More: AstraZeneca
Quince Therapeutics Completes Patient Enrolment in P-III (NEAT) Trial of eDSP for Ataxia-Telangiectasia
Read More: Quince Therapeutics
Keros Therapeutics Reports First Patient Dosing in P-III (RENEW) Trial of Elritercept for Transfusion-Dependent Anemia in Adults with MDS
Read More: Keros Therapeutics
GSK Reports the US FDA’s Application Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease
Read More: GSK
Ascentage Pharma Reports the NMPA’s Conditional Approval of Lisaftoclax for the Treatment of CLL/SLL
Read More: Ascentage Pharma
Bayer Reports the US FDA’s Approval of Kerendia (Finerenone) to Treat Heart Failure (HF)
Read More: Bayer
Ultragenyx Reports the Health Canada’s Approval of Evkeeza (evinacumab) to Treat Children with Homozygous Familial Hypercholesterolemia (HoFH)
Read More: Ultragenyx
KalVista Reports the MHRA Approval of Ekterly (Sebetralstat) for Treating Hereditary Angioedema
Read More: KalVista
Eli Lilly Receives the Health Canada’s Approval for Omvoh (Mirikizumab) to Treat Crohn’s Disease (CD)
Read More: Eli Lilly
The US FDA Approves GSK’s Shingrix Prefilled Syringe Presentation to Protect Individuals Against Shingles
Read More: GSK
Rocket Pharmaceuticals Receives the US FDA’s RMAT Designation of RP-A601 to Treat PKP2-Arrhythmogenic Cardiomyopathy
Read More: Rocket Pharmaceuticals
Daiichi Sankyo Receives the US FDA’s Breakthrough Therapy Designation for Enhertu + Perjeta to Treat HER2+ Breast Cancer
Read More: Daiichi Sankyo
The US FDA Grants Priority Review to Johnson & Johnson’s TAR-200 for BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)
Read More: J&J
BI Collaborates with LEO Pharma to Commercialize & Develop Spevigo
Read More: BI and LEO Pharma
Sun Pharma Launches Leqselvi (Deuruxolitinib) to Treat Severe Alopecia Areata in the US
Read More: Sun Pharma
Otsuka Pharmaceutical Acquires CAN10 Immunology Program from Cantargia for ~$613M
Read More: Otsuka Pharmaceutical and Cantargia
Debiopharm Enters a ~$267M Licensing Deal with Repare Therapeutics for Lunresertib
Read More: Debiopharm and Repare Therapeutics
JCR Pharmaceuticals Collaborates with Acumen Pharmaceuticals to Develop Novel Alzheimer’s Therapies
Read More: JCR Pharmaceuticals and Acumen Pharmaceuticals
Nicox and Kowa Enter a Licensing Agreement for NCX 470 to Treat Glaucoma
Read More: Nicox and Kowa
NKGen Biotech Partners with HekaBio to Accelerate Troculeucel Development in Japan
Read More: NKGen Biotech and HekaBio
RIVANNA Receives the US FDA 510(k) Clearance for Accuro3S System and SpineNav-AI Image Processing Software
Read More: RIVANNA
Saluda Medical Reports Full Launch of EVA Sensing Technology for Spinal Cord Stimulation in the US
Read More: Saluda Medical
Becton Dickinson’s Biosciences & Diagnostic Solutions Business to Combine with Waters in a $17.5B Deal
Read More: Becton Dickinson and Waters
Biocon Biologics’ Kirsty (Biosimilar, NovoLog) Secures the US FDA’s Approval
Read More: Biocon Biologics
Bio-Thera Reports the US FDA’s BLA Acceptance of BAT2506 (Biosimilar, Simponi)
Read More: Bio-Thera
Samsung Bioepis Collaborates with Harrow to Commercialize its Ophthalmology Biosimilars in the US
Read More: Samsung Bioepis and Harrow
Caranx Medical’s TAVIPILOT Soft Receives the US FDA Clearance for Real-Time Guidance of Transcatheter Heart Valve Implantation
Read More: Caranx Medical
Related Post: PharmaShots Weekly Snapshots (Jun 07, 2025 – Jul 11, 2025)
