PharmaShots Weekly Snapshots (March 03, 2025 – March 07, 2025) 

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & DigiHealth. Check out our full report below: GSK Presents Pooled Analysis from P-III (ANCHOR-1 & 2) Trial of Depemokimab for CRSwNP at AAAAI/WAO Joint Congress 2025 Read More: GSK Daiichi Sankyo Reports Interim Data of P-III (DESTINY-Gastric04) Study…

BySenior EditorMarch 7, 2025

NEWS

Johnson & Johnson MedTech Launches Shockwave Javelin Peripheral IVL Catheter in the US

Shots: Shockwave Medical (J&J MedTech’s company) has launched Shockwave Javelin peripheral IVL catheter in the US to modify calcium & cross extremely narrowed vessels in pts with peripheral artery disease (PAD) Shockwave Javelin was studied in FORWARD PAD IDE trial that demonstrated similar safety & effectiveness compared to balloon-based Shockwave IVL catheters, regardless of…

ByRidhi RastogiMarch 6, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (February 24, 2025 – February 28, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & DigiHealth. Check out our full report below: Estrella Immunopharma Reports the Approval to Start a Higher Dose Cohort After the Completion of First Dose Cohort in STARLIGHT-1 Study Read More: Estrella Immunopharma Regeneron Presents P-I/II (CHORD) Trial Data…

BySenior EditorFebruary 28, 2025

NEWS

Visby Medical Reports the US FDA Clearance and CLIA Waiver for Point-of-Care Respiratory Health Test

Shots: The US FDA granted 510(k) clearance (previously granted with EUA in Dec’22) and CLIA waiver for point-of-care respiratory health test. The Visby Medical Respiratory Health Test is a rapid PCR test used to detect and differentiate between upper respiratory infections caused by influenza (Flu) A & B and SARS-CoV-2 (COVID-19) Under the…

ByRidhi RastogiFebruary 28, 2025

NEWS

ABANZA Reports the US FDA 510(k) Clearance of WasherCap Mini for Orthopedic Surgeries

Shots: The US FDA has granted 510(k) clearance to WasherCap Mini (knotless suture & tape fixation) system, allowing bidirectional tension control in various procedures incl. meniscal root repair & ACL reconstruction WasherCap Mini has provided superior fixation strength & reduced displacement during cyclic loading compared to traditional devices in biomechanical testing, independent of the…

ByRidhi RastogiFebruary 27, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (February 17th, 2025 – February 21th, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, COVID 19 & Biosimilars. Check out our full report below: AstraZeneca Presents Post-Hoc Data from P-III (NIAGARA) Trial of Imfinzi in Muscle-Invasive Bladder Cancer Patients regardless of Complete Pathology Response at ASCO GU 2025 Read More: AstraZeneca Exelixis Presents 5-year…

BySenior EditorFebruary 21, 2025

NEWS

The US FDA Approves MED-EL’s Sonnet 3 Audio Processor for Optimal Hearing

Shots: The US FDA has approved the Sonnet 3 audio processor for MED-EL cochlear implants; commercially available in early 2025. Also, Pts implanted with MED-EL as of Sep 1, 2024, can access one-time exchange for Sonnet 3 in the TechSwap Program Sonnet 3 is 2g lighter & ~18% shorter than Sonnet 2 with features…

ByRidhi RastogiFebruary 18, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (February 10th, 2025 – February 14th, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health & Biosimilars. Check out our full report below: Eli Lilly Reveals VIVID-2 Study Data of Omvoh to Treat Crohn's Disease Read More: Eli Lilly Regeneron Reveals Data from Extended P-III (PULSAR) Trial of Eylea HD for Wet Age-related Macular Degeneration Read…

BySenior EditorFebruary 14, 2025

NEWS

Johnson & Johnson MedTech Launches Cereglide 92 Catheter System in the US for Acute Ischemic Stroke

Shots: J&J MedTech has launched the Cereglide 92 Catheter System with the Innerglide 9 delivery aid in the US to ease insertion & guidance of interventional devices in the neurovascular system Cereglide 92 features a .092” inner diameter with Innerglide 9 delivery aid, Brite-line tech for complete catheter visibility, & TruCourse for flexibility to…

ByRidhi RastogiFebruary 13, 2025

NEWS

Ibex Medical Analytics Receives the US FDA’s 510(k) Clearance for Ibex Prostate Detect

Shots: The US FDA has granted 510(k) clearance to Ibex Prostate Detect, which generates heatmaps using AI to detect small & rare missed prostatic cancers In studies, the device showed 99.6% PPV for cancer heatmap accuracy & detected 13% rate of missed cancer in pts initially diagnosed as benign, where these false negatives were later confirmed…

ByRidhi RastogiFebruary 11, 2025

PharmaShots Weekly Snapshots (March 03, 2025 – March 07, 2025)

Johnson & Johnson MedTech Launches Shockwave Javelin Peripheral IVL Catheter in the US

PharmaShots Weekly Snapshots (February 24, 2025 – February 28, 2025)

Visby Medical Reports the US FDA Clearance and CLIA Waiver for Point-of-Care Respiratory Health Test

ABANZA Reports the US FDA 510(k) Clearance of WasherCap Mini for Orthopedic Surgeries

PharmaShots Weekly Snapshots (February 17th, 2025 – February 21th, 2025)

The US FDA Approves MED-EL’s Sonnet 3 Audio Processor for Optimal Hearing

PharmaShots Weekly Snapshots (February 10th, 2025 – February 14th, 2025)

Johnson & Johnson MedTech Launches Cereglide 92 Catheter System in the US for Acute Ischemic Stroke

Ibex Medical Analytics Receives the US FDA’s 510(k) Clearance for Ibex Prostate Detect

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