GlaxoSmithKline

The RH5.1/Matrix-M malaria vaccine, tested in a phase 2b trial on 361 children, shows safety, effectiveness, and high immunogenicity, potentially becoming the first blood-stage vaccine, complementing existing pre-erythrocytic vaccines.

In 2024, India's CDSCO approved 19 new drugs, including next-gen therapies for chronic diseases by global majors. Eli Lilly's Mounjaro for diabetes/obesity, Orchid Pharma's Enmetazobactam for resistant bacteria, Cipla's plazomicin for UTIs, Sun Pharma's Etifoxine for anxiety, Dr Reddy's Elobixibat for constipation, and Zydus/Lupin's Vonoprazan for stomach ulcers were notable. New cancer drugs like Eli Lilly's Retevmo and Zydus's nelarabine were also approved.

FDA granted orphan drug designation to VGT-1849A, a selective ASO-based JAK2 inhibitor for treating polycythemia vera (PV). PV, a rare hematologic malignancy, affects 1 in 2000 individuals in the US and is caused by a JAK2 V617F mutation. VGT-1849A aims to reduce JAK2 activity, potentially offering targeted efficacy and improved safety over current JAK2 inhibitors.

Dostarlimab, a PD-1-blocking antibody, received FDA Breakthrough Therapy Designation for locally advanced dMMR/MSI-H rectal cancer, based on a 100% clinical complete response rate. It eradicates tumors without surgery, radiation, or chemotherapy, offering a life-changing immunotherapy for patients.

GSK plc announced the EMA granted PRIME Designation to GSK’227, a B7-H3-targeted ADC for relapsed ES-SCLC. This follows the US FDA’s Breakthrough Therapy Designation in 2024. The designation is supported by ARTEMIS-001 study data, with GSK initiating a global phase I trial for GSK’227. Lung cancer, particularly SCLC, is a significant global health issue.

Novo Holdings completes $16.5B Catalent Pharma Solutions buyout. Merck pays $112M upfront for obesity pill. Ottimo Pharma raises $140M for cancer therapy. Novo Nordisk invests $1.2B in Denmark factory. Angitia Biopharmaceuticals raises $120M for musculoskeletal candidates. Novartis closes MorphoSys sites, laying off 330. SiteOne Therapeutics secures $100M for non-opioid pain drugs. Novo Nordisk's obesity drug underperforms. Bristol Myers Squibb invests $100M in BioArctic's Alzheimer antibodies. Sudan's healthcare collapses. Tonix Pharmaceuticals files NDA for fibromyalgia drug. Neurocrine Biosciences wins FDA approval for Crenessity. Edgewise Therapeutics discusses accelerated approval for Becker muscular dystrophy. FDA places partial hold on PepGen's Duchenne therapy. Checkpoint Therapeutics' immunotherapy approved. WHO opens Academy in Lyon. GSK's Jemperli earns FDA Breakthrough status. Sanofi's duvakitug shows remission in ulcerative colitis. Sandoz agrees to $275M settlement over drug pricing. Pfizer projects 2025 earnings. Mesoblast's Ryoncil approved as 1st MSC therapy for graft-vs-host disease.

The FDA granted Jemperli (dostarlimab-gxly) a breakthrough therapy designation for locally advanced dMMR/MSI-H rectal cancer, marking its second designation for this population. Jemperli showed a 100% clinical complete response rate in a phase 2 trial, supporting its potential to improve treatment for patients with this condition.

GSK's FIRST-ENGOT-OV44 trial showed Zejula (niraparib) and Jemperli (dostarlimab) significantly improved PFS in first-line advanced ovarian cancer. OS did not meet statistical significance. Safety profiles were consistent with individual agents. The trial is part of GSK's focus on gynecological cancers.

RH5.1/Matrix-M, the first blood-stage malaria vaccine, is safe, effective, and could complement pre-erythrocytic vaccines, providing a second line of defence against malaria. The vaccine demonstrated 55% efficacy against clinical malaria and 80% against high parasite levels in a Phase IIb trial.

Inter-American Court of Human Rights ruled El Salvador violated a woman's rights in a 2013 abortion case. GSK's cancer drug combination met major goals in trials. Novo Nordisk faced investor discontent over its obesity drug trial. Vertex made a cystic fibrosis breakthrough, and Eli Lilly received FDA approval for a sleep apnea weight-loss drug.