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,…
NEWS
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…
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…
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…
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…
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…
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 2025P1 data showed 0.53 mean & 0 median…
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…
Shots:Alumis & ACELYRIN have entered into a definitive agreement to merge, with ACELYRIN stockholders receiving 0.4274 Alumis shares/share, owning 45% of the combined entity - "Alumis"; closing expected in Q2’25
As of Dec 31, 2024, Alumis & ACELYRIN had ~$289M & ~$448M in cash as well as investments, respectively, with a pro forma…
Shots:Relmada acquired the Sepranolone from Asarina for $3.12M via an asset purchase agreement to develop it as a potential treatment for Tourette syndrome (TS) & other compulsive disorders
Sepranolone (10mg, BIW, SC) is a GABAA-modulating steroid antagonist that is being investigated in a P-IIa trial, assessing it with SoC vs SoC alone in…

