NEWS

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

Alumis Signs a Definitive Merger Agreement with ACELYRIN to Develop Novel Therapies for Immune-mediated Diseases

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…

February 7, 2025

Relmada Therapeutics Acquires Sepranolone from Asarina Pharma for ~$3.12M

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…

February 7, 2025

Merck Initiates P-III (waveLINE-010) Trial of Zilovertamab Vedotin to Treat Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL)

Shots: Merck initiated P-III (waveLINE-010) trial to assess zilovertamab vedotin (ROR1- ADC) + R-CHP (Rituximab, cyclophosphamide, doxorubicin & prednisone) vs R-CHOP (R-CHP + vincristine) to treat pts with previously untreated DLBCL; global enrolment is ongoing Trial will enrol ~1,046 pts to assess PFS as the 1EP, with 2EPs incl. OS, event-free survival, duration of…

February 7, 2025

The US FDA Approves Supernus’ Onapgo (Apomorphine Hydrochloride) for Parkinson’s Disease

Shots: The US FDA has approved Onapgo injection (SPN-830; SC infusion device) to treat motor fluctuations in adults with advanced Parkinson’s disease; commercially available in Q2’25 Approval was based on a 12wk P-III trial assessing Onapgo (n=53) vs PBO (n=51) in Parkinson’s pts (N=107), evaluating 1EP of mean change in total daily OFF time…

February 7, 2025

NEWS

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

Alumis Signs a Definitive Merger Agreement with ACELYRIN to Develop Novel Therapies for Immune-mediated Diseases

Relmada Therapeutics Acquires Sepranolone from Asarina Pharma for ~$3.12M

Merck Initiates P-III (waveLINE-010) Trial of Zilovertamab Vedotin to Treat Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL)

The US FDA Approves Supernus’ Onapgo (Apomorphine Hydrochloride) for Parkinson’s Disease

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