Positive phase III results for Roche’s Gazyva/Gazyvaro show superiority to standard therapy alone in people with lupus nephritis The REGENCY study met its primary endpoint, demonstrating statistically significant and clinically meaningful treatment benefits in people with active lupus nephritis Gazyva/Gazyvaro is designed to target an underlying cause of lupus nephritis, aiming to prevent or delay progression to end-stage kidney disease1,2 Lupus nephritis is a potentially life-threatening manife

September 25, 2024 – Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, today announced the filing of a new patent application protecting MDG2021, a T cell receptor engineered T cell (TCR-T) therapy targeting Kirsten rat sarcoma viral oncogene homologue (KRAS) G12D with human leukocyte antigen (HLA)-A*11, for the TCR-T therapy alone as well

Genespire raises €46.6 million (~$52 million) in a Series B round to advance its first pediatric in-vivo gene therapy into the clinic One of the largest private Italian Biotech company financings to date Financing co-led by Sofinnova Partners, XGEN Venture and CDP Venture Capital forming a strong syndicate with Indaco SGR Funds dedicated to advancing off-the-shelf pediatric gene therapy for Methylmalonic Acidemia (MMA) into the clinic, and to bolstering the Company’s gene therapy pipeline 25 Sep

Sept. 24, 2024 -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, and its wholly-owned subsidiary, TopAlliance Biosciences Inc. (TopAlliance Biosciences), announce that the European Commission (EC) has approved toripalimab (European trade name: LOQTORZI®) for the treatment of two indications: Toripalimab in combination with

Boehringer is advancing the development of SZN-413 to prepare it for potential future clinical testing SZN-413 is a bi-specific antibody targeting Frizzled Class Receptor 4 (Fzd4) mediated Wingless/Integrated (Wnt) signaling, designed using Surrozen’s SWAP™ technology SZN-413 offers the possibility of restoring retinal function in patients living with retinal vascular diseases Sept. 24, 2024 -- Surrozen, Inc. (“Surrozen” or the “Company”) (Nasdaq: SRZN) announced that Boehringer Ingelheim will

An Independent Data and Safety Monitoring Board (DSMB) Recently Evaluated the Interim Patient Safety Database for Oral Simufilam in On-going Phase 3 Trials. The DSMB Recommended Both Phase 3 Trials Continue as Planned, Without Modification. Final Clinical Safety Data for Simufilam Are Expected at the Conclusion of the Phase 3 Program. Sept. 24, 2024 -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today announced the completion of a third interim

Investigational immunotherapy candidate, VTP-1000, seeks to address significant unmet need in people with celiac disease. An estimated one in 100 people globally suffer from celiac disease, for which no approved treatments currently exist. The first-in-human Phase 1 trial aims to evaluate the safety and tolerability in adults with celiac disease. Sept. 24, 2024 -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidat

Araris Biotech AG Expands its IP Portfolio with the Acquisition of Innate Pharma’s Portfolio of Transglutaminase Patents for the Generation of Antibody-Drug Conjugates (ADCs) September 24, 2024 – Araris Biotech AG (“Araris”), a Swiss oncology biotech company developing next-generation antibody-drug conjugates (ADCs), today announced it has entered into an Agreement with Innate Pharma (“Innate”). Under the agreement, Innate will assign its portfolio of patents related to its ADC transglutaminase

Alvotech is one of two companies known to have initiated a global or multi-country confirmatory patient study for a biosimilar candidate to Entyvio® Sales of Entyvio (vedolizumab) were about $5.4 billion globally in the last 12 months up to June 30, 2024 Entyvio is indicated for the treatment of Ulcerative Colitis and Crohn’s disease Sept. 25, 2024 -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide,

September 23, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced that the European Commission has conditionally approved Iqirvo®1 (elafibranor) 80mg tablets for the treatment of Primary Biliary Cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA