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…

ByRidhi RastogiFebruary 7, 2025

NEWS

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…

ByRidhi RastogiFebruary 7, 2025

NEWS

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…

ByRidhi RastogiFebruary 7, 2025

NEWS

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…

ByRidhi RastogiFebruary 7, 2025

NEWS

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…

ByRidhi RastogiFebruary 7, 2025

NEWS

Adicet Bio’s ADI-001 Secures the US FDA’s Fast-Track Designation for Treating Refractory SLE with Extrarenal Involvement

Shots: The US FDA has granted FTD to ADI-001 for treating adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement Adicet Bio is advancing ADI-001 in six autoimmune indications, with patient enrollment ongoing in the P-I LN study. Enrollment in SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM, or myositis), and stiff…

ByRidhi RastogiFebruary 6, 2025

NEWS

AstraZeneca Reports CHMP Positive Opinion for Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Shots: The CHMP has recommended Imfinzi for the treatment of LS-SCLC pts whose disease has not progressed after receiving Pt-based CRT; regulatory review underway in Japan & other regions Opinion was based on P-III (ADRIATIC) trial (n=730) assessing Imfinzi (1500mg, IV, Q4W) with or without Imjudo (75mg, IV, Q4W × 4 cycles) followed by Imfinzi…

ByRidhi RastogiFebruary 6, 2025

NEWS

Accord Healthcare (Intas) Receives EC Approval for Hetronifly (Serplulimab) as 1L Treatment of ES-SCLC

Shots: The EC has approved Hetronifly + CT (carboplatin & etoposide) as a 1L treatment for extensive-stage small cell lung cancer (ES-SCLC) pts. Serplulimab, an anti-PD-1 mAb for 1L SCLC therapy, is approved in China and several SEA countries. ESMO rates it 4/5 on the MCBS for ES-SCLC. Its trial results were published in…

ByRidhi RastogiFebruary 6, 2025

NEWS

The US FDA grants RMAT Designation to Gradalis’ Vigil for Advanced Ovarian Cancer

Shots: The US FDA has granted RMAT designation to Vigil (gemogenovatucel-T) as a maintenance therapy for newly diagnosed advanced Stage IIIb/IV HRP ovarian cancer pts with cTMB-H who achieved complete response post-debulking surgery & frontline Pt-based doublet CT Designation was backed by ongoing P-IIb (VITAL) trial assessing Vigil vs PBO showed improved RFS (1EP) in all…

ByRidhi RastogiFebruary 6, 2025

NEWS

Imagene Partners with Tempus AI to Develop AI-Powered Diagnostics for NSCLC

Shots: Imagene & Tempus AI have collaborated to advance lung cancer diagnostics by enhancing biomarker prediction, integrating AI tools into clinical workflows, & allowing commercial access to diagnostic solutions Collaboration will integrate Imagene's AI multi-gene panel for rapid NSCLC biomarker prediction from biopsy images with Tempus' clinical reach & real-world data, creating a unified…

ByRidhi RastogiFebruary 6, 2025

Ridhi Rastogi

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

Adicet Bio’s ADI-001 Secures the US FDA’s Fast-Track Designation for Treating Refractory SLE with Extrarenal Involvement

AstraZeneca Reports CHMP Positive Opinion for Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Accord Healthcare (Intas) Receives EC Approval for Hetronifly (Serplulimab) as 1L Treatment of ES-SCLC

The US FDA grants RMAT Designation to Gradalis’ Vigil for Advanced Ovarian Cancer

Imagene Partners with Tempus AI to Develop AI-Powered Diagnostics for NSCLC

Contact US

FOLLOW US