Category Regulatory

Celltrion Reveals New Two-Year Results of Subcutaneous Infliximab (CT-P13 SC) for Treating Inflammatory Bowel Disease (IBD) at 19th ECCO Congress

Celltrion presented encouraging findings from the extensive LIBERTY studies, including LIBERTY-CD 1 and LIBERTY-UC 2, focusing on patients with Alzheimer’s disease, Crohn’s disease (CD), or moderately to severely active ulcerative colitis (UC). Additionally, the company shared endoscopic results from a…

Read MoreCelltrion Reveals New Two-Year Results of Subcutaneous Infliximab (CT-P13 SC) for Treating Inflammatory Bowel Disease (IBD) at 19th ECCO Congress

Ironwood Pharmaceuticals to Showcase Four Abstracts at ASPEN’s 2024 Nutrition Science & Practice Conference

Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a company specializing in gastrointestinal healthcare, has revealed plans to present findings from four studies examining apraglutide in adults diagnosed with short bowel syndrome with intestinal failure (SBS-IF), a condition where individuals rely on parenteral…

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Health Canada Grants Approval for Remsima™ SC in Treating Inflammatory Bowel Disease (IBD)

Celltrion Healthcare Canada Limited has announced today that Health Canada has granted approval for Remsima™ SC as maintenance therapy for adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). Remsima™ SC, a subcutaneous form of infliximab,…

Read MoreHealth Canada Grants Approval for Remsima™ SC in Treating Inflammatory Bowel Disease (IBD)

Initiative by WHO to Enhance Global Health Resilience through Biomanufacturing Workforce Training

The COVID-19 pandemic has brought to light the vulnerabilities inherent in global supply chains, especially affecting the access of low- and middle-income countries (LMICs) to crucial medical supplies. The disproportionate concentration of manufacturing capacity in a handful of nations and…

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Sarepta Therapeutics Receives U.S. FDA Acceptance for Efficacy Supplement Enabling Expansion of ELEVIDYS Indication

Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a pioneer in precision genetic medicine for rare diseases, has announced today that the U.S. Food and Drug Administration (FDA) has accepted and filed the Company’s efficacy supplement to the Biologics License Application (BLA) for…

Read MoreSarepta Therapeutics Receives U.S. FDA Acceptance for Efficacy Supplement Enabling Expansion of ELEVIDYS Indication

Positive Results for Mosunetuzumab in Japanese Phase I Study: Meeting Primary Endpoint for Relapsed and Refractory Follicular Lymphoma Expansion Cohort

Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) has revealed that the anti-CD20/CD3 bispecific antibody mosunetuzumab has successfully met the primary endpoint of achieving a complete response rate (CRR) in an expansion cohort within the Japanese Phase I study. This study aimed…

Read MorePositive Results for Mosunetuzumab in Japanese Phase I Study: Meeting Primary Endpoint for Relapsed and Refractory Follicular Lymphoma Expansion Cohort

Japan ATTR-CM Trial Shows Promise for Acoramidis, Mirroring Global Results

Encouraging Outcomes in Japan Phase III Trial of Acoramidis for Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM) Consistent with Global ATTRibute-CM Phase III Trial Positive high-level results from the Japan Phase III trial of acoramidis in adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) showed…

Read MoreJapan ATTR-CM Trial Shows Promise for Acoramidis, Mirroring Global Results

Extended Study Highlights Persistent Retinal Drying and Vision Enhancement with Roche’s Vabysmo in Retinal Vein Occlusion

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new 72-week data from two global Phase III studies, BALATON and COMINO, evaluating Vabysmo® (faricimab) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO).1,2 Whereas available RVO treatments are…

Read MoreExtended Study Highlights Persistent Retinal Drying and Vision Enhancement with Roche’s Vabysmo in Retinal Vein Occlusion

Atara Biotherapeutics and Pierre Fabre Laboratories Release Phase 3 ALLELE Tab-cel® Results in The Lancet Oncology

Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, and Pierre Fabre Laboratories, a global player in oncology and  responsible for worldwide…

Read MoreAtara Biotherapeutics and Pierre Fabre Laboratories Release Phase 3 ALLELE Tab-cel® Results in The Lancet Oncology