Eli Lilly and Company (Lilly) has reported positive topline results from the ATTAIN-MAINTAIN Phase 3 trial evaluating orforglipron, its once-daily oral glucagon-like peptide-1 (GLP-1) receptor agonist, for maintenance of weight loss in patients previously treated with injectable incretins. The trial enrolled participants who had completed 72 weeks of treatment with semaglutide (Wegovy) or tirzepatide (Zepbound) […]
For decades, China’s biopharma sector was best known for its rapid scaling of biosimilars, generics, and “fast follower” biologics. Industry watchers, both inside and outside the country, regarded Chinese firms as volume leaders but not science front-runners. This is now changing. The first-in-human dosing of IBI3011, Innovent Biologics’ anti-IL-1RAP monoclonal antibody, marks a turning point […]
Roivios Ltd., a clinical-stage medical device developer focused on kidney health, has reported promising results from its first-in-human trial of the JuxtaFlow Renal Assist Device. This investigational system applies controlled negative pressure to the renal pelvis to enhance urine output and sodium excretion in patients with diuretic-resistant cardiorenal syndrome and acute decompensated heart failure. While […]
The rapid progress of artificial intelligence in medical imaging is creating fresh optimism among healthcare leaders seeking to close the persistent equity gap in breast cancer screening. The regulatory push by Lunit, a Seoul-based AI diagnostics firm, for its Lunit INSIGHT Risk model, which estimates a woman’s five-year breast cancer risk directly from mammogram images, […]
The landscape of metastatic breast cancer treatment is facing a fundamental rethink, with the oncology field laser-focused on one of its greatest clinical challenges: how to break immune resistance and stop metastatic spread. Despite a wave of checkpoint inhibitor approvals and initial enthusiasm, progress in metastatic breast cancer—especially for subtypes like triple-negative and HER2-positive disease—has […]
Pfizer Inc. has moved a step closer to reshaping the treatment paradigm for one of hemophilia’s most challenging patient subgroups. The company’s investigational therapy HYMPAVZI (marstacimab) demonstrated a 93 percent reduction in bleeding episodes in patients with hemophilia A or B who have developed inhibitors, according to data presented at the 67th American Society of […]
When Amgen (NASDAQ: AMGN) announced that the U.S. Food and Drug Administration had approved UPLIZNA (inebilizumab-cdon) for adults with generalized myasthenia gravis (gMG), the industry’s attention snapped not just to the therapy’s mechanism but to its twice-yearly maintenance schedule. For patients, this marks a seismic shift away from the exhausting cycle of daily oral immunosuppressants […]
The European Commission’s recent approval of €47 million in German state aid for Vetter Pharma’s new aseptic filling facility in Saarlouis marks more than a regional win. It signals a structural shift in how Europe views contract manufacturing organizations, or CDMOs—not merely as outsourcing vendors, but as core pillars of supply chain resilience, regional economic […]
Few ideas have captivated both the scientific imagination and biotech investment flows quite like the cancer vaccine. For decades, the industry narrative was full of hope—and disappointment. The graveyard of failed trials stretches from Dendreon’s Provenge to once-hyped peptide and dendritic cell platforms. For every announcement of an “immune breakthrough,” there seemed to be a […]
