Shots:
Seegene has launched the STAgora platform for infectious disease analysis, with a formal launch planned at ADLM 2025to seek business partnerships & highlight STAgora's integration with Cureca PCR system
STAgora, when integrated with Seegene’s syndromic quantitative PCR tech, provides advanced visibility into single & multi-pathogen infections to allow clinicians to make faster, more informed…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, and Biosimilar. Check out our full report below:
Neurocrine Reports Data From KINECT-HD Study Evaluating INGREZZA in Huntington’s Disease (HD)
Read More: Neurocrine
UCB Reports the P-III Data of Fenfluramine in CDKL5 Deficiency Disorder (CDD) Patients
Read More: UCB …
Shots:
MatOrtho has reported the European CE Mark approval of ReCerf for hip resurfacing arthroplasty, allowing wider availability in UK, EU & markets accepting CE mark approval
ReCerf was previously approved by Australia’s TGA in Nov 2024 & was used in over 1,600 pts since 2018, with highly positive patient-reported outcomes & a low 6yr. revision…
Shots:
The US FDA has granted 510(k) clearance to Felix NeuroAI Wristband for the treatment of essential tremor in the upper limbs of the adults; available in select US states in 2025, with nationwide availability anticipated in 2026
Clearance was supported by TRANQUIL study assessing Felix wristband vs sham device, which showed reduced tremors & improved…
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)…
Shots:
Nitinotes has received the FDA’s IDE approval to begin a pivotal trial of its EndoZip System for endoscopic sleeve gastroplasty; enrollment is set to start by Q3’25
The trial will assess the safety & efficacy of the EndoZip System for obesity pts. (n=184) across up to 10 US and additional international sites. As a…
This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, Animal Health & DigiHealth. Check out our full report below:
Johnson & Johnson Reports P-II (RedirecTT-1) Trial Data on Talvey + Tecvayli for R/R Multiple Myeloma
Read More: J&J
Camurus Reports Topline P-IIb (POSITANO) Trial Data on CAM2029 for…
Shots:
J&J MedTech has launched Variable Angle Optimized Locking Technology (VOLT) Distal Radius (Wrist) & VOLT Proximal Humerus 3.5 Plating System in the US
VOLT Wrist, developed with the AO Technical Commission, features the VOLT Two-Column Distal Radius Rim Plate with a new shape that sits more distal to target fragments & is less prominent…
Shots:
The US FDA has approved integrated sacral neuromodulation (iSNM) system to treat urinary urge incontinence (UUI)
iSNM device was evaluated in a P-II trial in 128 pts, which showed 84.2% pts achieved ≥50% reduction in urgent leaks, with 84% & 42% responders experiencing >75% & 100% reduction, respectively in UUI symptoms at 6mos.; 3.5x…
Shots:
Brain Navi Biotechnology has received the US FDA’s 510(k) clearance for NaoTrac neurosurgical robot
NaoTrac is a stereotaxic guiding surgical device that uses SMART tech for rapid, non-contact, frameless registration by aligning the pts anatomy with preoperative imaging, & a robotic arm to guide instruments while keeping the surgeon in control
NaoTrac integrates AI…

