Skip to content Skip to footer
Subscribe Now
Fresenius Kabi
News

Fresenius Kabi Reports the US FDA’s 510(k) Clearance for Adaptive Nomogram, Improving Plasma Collection Efficiency

Shots: The US FDA has granted 510(k) clearance to Adaptive Nomogram algorithm in the Aurora Xi Plasmapheresis System to improve plasma collection efficiency Clearance was based on a trial of Adaptive Nomogram in Aurora Xi Software Version 2.0 vs the existing Optimized Nomogram involving >52,400 procedures that met its 1EP, depicting increased plasma volume…
January 29, 2025

Read more

ITM
News

ITM Reports Topline Data from P-III (COMPETE) Trial of ITM-11 to Treat Grade 1 or Grade 2 Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

Shots: The P-III (COMPETE) trial assessed ITM-11 (7.5 GBq + nephroprotective amino acid, Q3M × max. 4 cycles) vs everolimus (10mg for ~30mos. or until disease progression) in patients (n=309) with inoperable, progressive, SSTR+ gr 1/2 GEP-NETs. The US FDA’s NDA submission is expected in 2025 The study met its 1EP of improved PFS,…
January 29, 2025

Read more

GSK
News

The EMA Accepts MAA for GSK’s Depemokimab as an Adjunctive to Treat Asthma with Type 2 Inflammation and CRSwNP

Shots: The EMA accepted depemokimab’s MAA as an add-on maintenance therapy for inadequately controlled asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as CRSwNP, based on P-III (SWIFT & ANCHOR) trials, respectively. NDA is also accepted by the NMPA & MHLW SWIFT-1 (n=382) & SWIFT-2 (n=380) studies assessed…
January 28, 2025

Read more

Daiichi Sankyo & Astrazeneca
News

Daiichi Sankyo and AstraZeneca Report the US FDA’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC), Progressed on Endocrine Therapies

Shots: The US FDA’s approval of Enhertu for HR+, HER2 low/ultralow MBC, progressed on endocrine therapies, was based on P-III (DESTINY-Breast06) study compared to CT shared at ASCO 2024 & published in The NEJM. AZ will pay $175M for this milestone Study depicted PFS of 36%, mPFS of 13.2 vs 8.1mos., cORR of 62.6%…
January 28, 2025

Read more

Weekly Snapshot

PharmaShots Weekly Snapshots (January 20, 2025 – January 24, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, DigiHealth, MedTech, Biosimilars, Animal Health & Biotech. Check out our full report below:         Novo Nordisk Reports Headline Results from P-IIIb (STEP UP) Study of Semaglutide 7.2mg in Obese Adults without Diabetes  Read More: Novo Nordisk  Yoltech Initiates a Dose-Escalation Study for YOLT-204 to Treat…
January 24, 2025

Read more

News

Medidata (Dassault Systèmes brand) and Tigermed Expand their Strategic Collaboration to Expedite Clinical Trials Globally

Shots: Medidata and Tigermed have expanded their 13yrs. collaboration to leverage the former’s Medidata Platform across all trial phases, enhancing workflows, regulatory compliance & delivery of therapies globally Tigermed will integrate the platform with their workflow, automate data capture, streamline operations to enhance trial efficiency for accelerating time to commercialize new therapies The…
January 24, 2025

Read more

News

Lisata Therapeutics and WARPNINE Reports Initial Results from P-Ib/IIa (iLSTA) trial of Certepetide Regimen in Pancreatic Ductal Adenocarcinoma (PDAC)

Shots: P-Ib/IIa (iLSTA) trial assessed certepetide (LSTA1; iRGD cyclic peptide) ± SoC CT ± Imfinzi in LA inoperable PDAC pts (N=30) randomized into 3 arms, with A1 (n=5) receiving SoC CT + PBO Imfinzi & PBO certepetide; A2 (n=5) receiving SoC CT + certepetide & PBO Imfinzi; A3 (n=20) receiving SoC CT + Imfinzi &…
January 24, 2025

Read more

News

Rakuten Medical Commences Global P-III (ECLIPSE) Study of ASP-1929 Plus Keytruda as a 1L Treatment of Recurrent Head and Neck Cancer

Shots: The company has begun P-III (ECLIPSE) trial of ASP-1929 (photoimmunotherapy) + Keytruda for HNSCC, with first patient treated at a site across the US. Recruitment is underway in Japan, Taiwan & other regions This global study aims at assessing safety & efficacy of ASP-1929 + Keytruda vs Keytruda-based SoC as a 1L treatment…
January 24, 2025

Read more

Load more

Sign Up to Our Newsletter

Be the first to know the latest updates

[mc4wp_form id="13387" element_id="style-1"]