NEWS

AliveDx Seeks US FDA’s 510(k) Clearance for MosaiQ AiPlex Multiplex Microarray

Shots: The US FDA has received 510(k) Application for MosaiQ AiPlex Multiplex Microarray to improve & accelerate diagnosis of celiac disease MosaiQ simplifies serological evaluation with syndromic approach by combining IgA & IgG isotypes to detect IgA deficiency & measure anti-tTG as well as anti-DGP (AU/mL) using just 20 μL of sample in single…

February 10, 2025

Regeneron Reveals Data from Extended P-III (PULSAR) Trial of Eylea HD for Wet Age-related Macular Degeneration

Shots: Regeneron reported 3yr. data from an extension study of P-III (PULSAR) trial of Eylea for wAMD pts, randomized to Eylea HD (8mg; Q3M or Q4M) or Eylea (2mg; Q2M) After 2yrs., 88% of Eylea HD patients maintained a dosing interval of ≥3 months, while in 60wk. extension, 77%, 58%, 40% & 24% (out…

February 10, 2025

Bio-Thera Collaborates with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) Across the US

Shots: Bio-Thera and Intas Pharmaceuticals have entered into an exclusive commercialization and license agreement for BAT2506, a biosimilar version of Simponi (golimumab) in the US As per the agreement, Bio-Thera is entitled to receive $21M upfront and an additional $143.5M in development and commercial milestones BAT2506 is an IgG1 monoclonal antibody targeting TNF-alpha,…

February 10, 2025

Samsung Bioepis and Teva Partners to Commercialize Epysqli (Biosimilar, Soliris) in the US

Shots: Samsung Bioepis and Teva have signed a development and commercialization license agreement for Epysqli (eculizumab-aagh), a biosimilar to Soliris (eculizumab), in the US Under the agreement, Samsung Bioepis will manage development, regulatory registration, manufacturing, and supply, while Teva will oversee commercialization in the US. The financial terms are confidential. This deal increases Teva's biosimilar…

February 10, 2025

Bio-Thera Reports the EMA’s MAA Acceptance of BAT2506 (Biosimilar, Simponi)

Shots: The EMA has accepted the MAA of BAT2506, a biosimilar version of Simponi (golimumab) Approval was backed by extensive analytical characterization and biosimilarity of BAT2506 in comparison to US & EU golimumab from P-I trial in healthy subjects, plus P-III trial (vs. EU Simponi) in active PsA pts depicting non-inferior efficacy & comparable…

February 10, 2025

Eli Lilly Reveals VIVID-2 Study Data of Omvoh to Treat Crohn’s Disease

Shots: Eli Lilly has reported 2yrs. data from VIVID-2 (OLE) study (incl. 1yr. of VIVID-1) of Omvoh for mod. to sev. Crohn's disease; regulatory review is underway in China, Canada, Japan & other regions In VIVID-1, 92.9% pts sustained clinical remission (CDAI) and 78.6% retained endoscopic remission (SES-CD ≤4 & ≥2-point decrease, with no…

February 10, 2025

Abbvie Reports the US FDA Approval for Emblaveo to Treat Complicated Intra-Abdominal Infections (cIAI)

Shots: The US FDA has approved Emblaveo (IV) + metronidazole for pts (≥18 yrs) with few or no therapy options for cIAI caused by susceptible gram -ve bacteria, incl. E. coli, K. pneumoniae, K. oxytoca, ECC, C. freundii complex, & S. marcescens; commercially available in Q3’25 Approval was based on prior aztreonam’s efficacy & safety data…

February 10, 2025

Bain Capital to Acquire Mitsubishi Tanabe Pharma for ~$3.3B

Shots: Bain Capital has signed to acquire Mitsubishi Tanabe Pharma in a carve-out deal from Mitsubishi Chemical Group at ~510 billion JPY (3.3 billion USD), is led by Bain Capital’s Private Equity teams in Asia, North America, and its Life Sciences team. The transaction is expected to close in Q3’25, pending regulatory approval, shareholder…

February 7, 2025

Novo Nordisk Reveals Interim Data from P-III (FRONTIER3) Trial of Mim8 for Haemophilia A with or without Inhibitors

Shots: The P-III (FRONTIER3) trial assessed Mim8 (SC) in 70 pts (1-11yrs.) with hemophilia A ± FVIII inhibitors in 2 parts: P1 involves Q1W prophylaxis therapy until 26wks. after which pts can stay on Q1W or switch to QM for further 26wks.; regulatory filings expected in 2025 P1 data showed 0.53 mean & 0 median…

February 7, 2025

Senseonics Seeks the CE Mark Approval for Eversense 365 System

Shots: Senseonics has filed for the CE Mark Approval of its Eversense 365 CGM system. If approved, it will be distributed in the EU (Germany, Italy, Spain, Poland, Switzerland, Sweden, & Andorra) by Ascensia Diabetes Care (Senseonics' commercial partner) Eversense offers longevity (1yr. vs 10-14 days for traditional CGMs), features a removable smart transmitter…

February 7, 2025

NEWS

AliveDx Seeks US FDA’s 510(k) Clearance for MosaiQ AiPlex Multiplex Microarray

Bio-Thera Collaborates with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) Across the US

Samsung Bioepis and Teva Partners to Commercialize Epysqli (Biosimilar, Soliris) in the US

Bio-Thera Reports the EMA’s MAA Acceptance of BAT2506 (Biosimilar, Simponi)

Eli Lilly Reveals VIVID-2 Study Data of Omvoh to Treat Crohn’s Disease

Abbvie Reports the US FDA Approval for Emblaveo to Treat Complicated Intra-Abdominal Infections (cIAI)

Bain Capital to Acquire Mitsubishi Tanabe Pharma for ~$3.3B

Novo Nordisk Reveals Interim Data from P-III (FRONTIER3) Trial of Mim8 for Haemophilia A with or without Inhibitors

Senseonics Seeks the CE Mark Approval for Eversense 365 System

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