NEWS

GSK Receives the US FDA’s Approval for Benlysta to Treat Active Lupus Nephritis (LN)

Shots: The US FDA has approved Benlysta (belimumab) 200 mg/mL Autoinjector for SC use in pts (age≥5) with active LN receiving standard therapy Benlysta (belimumab) is a BLyS-specific inhibitor that reduces B cell survival and differentiation by binding to soluble BLyS, targeting autoreactive B cells. With this approval, GSK offers a first-of-its-kind at-home SC option…

June 25, 2025

Xcell Biosciences and ThermoFisher Enter Into a Joint Research Collaboration to Advance Cell Therapies

Shots: Xcell Biosciences entered into a strategic collaboration with ThermoFisher Scientific to advance the development of Treg and TIL cell therapies for autoimmune and solid tumor treatments The joint research aims to develop methodologies for enhancing the efficacy of Tregs and TILs, while streamlining and scaling cell therapy manufacturing for improved accessibility and reproducibility across…

June 25, 2025

Verastem Oncology Reports First Patient Dosing with VS-7375 in P-I/IIa Study for KRAS G12D Advanced Solid Tumors

Shots: Verastem reported the dosing of the first patient (US) for P-I/IIa study (VS-7375-101) assessing the safety, tolerability, and efficacy of VS-7375 The dose-escalation phase of the study starts at 400mg, based on results from a P-I/II study conducted by GenFleet in China, and presented initial safety and efficacy data at ASCO’25 Upon reaching the…

June 25, 2025

DARZALEX (Daratumumab) Receives Positive CHMP Opinion for High-Risk Smouldering Multiple Myeloma

Shots: Janssen-Cilag (Johnson & Johnson) announced that the CHMP of the EMA has recommended approving DARZALEX (daratumumab) SC as the first therapy for adults with high‑risk smouldering multiple myeloma (SMM) The CHMP’s recommendation is based on the P-III (AQUILA) study data evaluating efficacy and safety of fixed-duration monotx. daratumumab SC compared with active monitoring (N=390)…

June 24, 2025

Accord Healthcare Reports the MHRA’s Approval of Hetronifly as 1L Treatment of ES-SCLC

Shots: The UK’s MHRA has approved Hetronifly (serplulimab) to treat previously untreated adults in the UK with extensive-stage small cell lung cancer (ES-SCLC) Approval were based on the global P-III (ASTRUM-005) study (n=585) across 128 trial sites, which showed a mFU of 42.4 mos. & 4-year OS rate of 21.9% with serplulimab + CT, confirming its long-term…

June 24, 2025

Johnson & Johnson launches ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM Contact Lens in the US and Canada

Shots: Johnson & Johnson launched ACUVUE OASYS MAX 1‑DAY MULTIFOCAL for astigmatism daily disposable lens in the U.S. and Canada for people with both astigmatism and presbyopia A study showed 95% of people wearing ACUVUE OASYS MAX 1-DAY MULTIFOCAL for ASTIGMATISM contact lenses reported clear vision during daily activities, while 87% saw clearly while driving…

June 24, 2025

PTC Therapeutics Receives the EC’s Approval for Sephience to Treat Phenylketonuria (PKU)

Shots: The EC has approved Sephience (sepiapterin) to treat PKU in pts of all ages and disease severities across all 30 EEA states; launch is anticipated in Germany in H1 of July Approval was based on APHENITY study results and long-term extension data showing durable effects and improved dietary flexibility Sephience is an oral synthetic…

June 24, 2025

Alvotech & Advanz Pharma Secure the CHMP’s Positive Opinion for AVT06 (Biosimilar, Eylea)

Shots: The CHMP has recommended AVT06, a biosimilar version of Eylea (aflibercept 2 mg), across all 30 EEA states AVT06 is a recombinant fusion protein that inhibits VEGF to reduce neovascularization and vascular permeability. The CHMP recommends MAA for wet AMD, visual impairment from macular oedema due to RVO (branch or central), diabetic macular oedema…

June 24, 2025

Merck Reports the Data from P-III (HYPERION) Study of WINREVAIR (sotatercept-csrk) in Adults with Recently Diagnosed PAH

Shots : The P-III (HYPERION) study evaluating Winrevair vs PBO (both in combination with background therapy) in recently diagnosed adults (N=320, >18) with PAH (WHO Group 1) functional class (FC) II or III at intermediate or high risk of disease progression The study met its 1EP of TTCW measured by the first confirmed morbidity or…

June 24, 2025

SpringWorks Therapeutics’ Nirogacestat Receives the CHMP’s Positive Opinion for Desmoid Tumors

Shots: The CHMP has recommended Nirogacestat as a monotx. for adults with progressing desmoid tumors needing systemic treatment, the EC’s decision is expected in Q3’25 Opinion was supported by the MAA on P-III (DeFi) global trial (N=142) assessing Nirogacestat (n=700) vs PBO (n=72), which met the 1EP, showing a 71% reduction in PFS vs PBO,…

June 23, 2025

NEWS

GSK Receives the US FDA’s Approval for Benlysta to Treat Active Lupus Nephritis (LN)

Xcell Biosciences and ThermoFisher Enter Into a Joint Research Collaboration to Advance Cell Therapies

Verastem Oncology Reports First Patient Dosing with VS-7375 in P-I/IIa Study for KRAS G12D Advanced Solid Tumors

DARZALEX (Daratumumab) Receives Positive CHMP Opinion for High-Risk Smouldering Multiple Myeloma

Accord Healthcare Reports the MHRA’s Approval of Hetronifly as 1L Treatment of ES-SCLC

Johnson & Johnson launches ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM Contact Lens in the US and Canada

PTC Therapeutics Receives the EC’s Approval for Sephience to Treat Phenylketonuria (PKU)

Alvotech & Advanz Pharma Secure the CHMP’s Positive Opinion for AVT06 (Biosimilar, Eylea)

Merck Reports the Data from P-III (HYPERION) Study of WINREVAIR (sotatercept-csrk) in Adults with Recently Diagnosed PAH

SpringWorks Therapeutics’ Nirogacestat Receives the CHMP’s Positive Opinion for Desmoid Tumors

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