Johnson & Johnson has secured European Commission approval for Imaavy (nipocalimab), a novel treatment for generalized myasthenia gravis (gMG). This authorization marks the first FcRn blocker approved in Europe for a broad population that includes both adults and adolescents (aged 12+), offering a new option for sustained disease control.
In a major move to improve affordability and counter the compounded drug market, Eli Lilly has cut the monthly cost of Zepbound to $299 for the starter dose. Available exclusively through LillyDirect, these new single-dose vials offer a significant discount for patients without insurance coverage. Read the full details on the new pricing structure and how it impacts the weight-loss drug market.
Novartis has secured FDA approval for Itvisma (onasemnogene abeparvovec-brve), marking a historic milestone as the first gene replacement therapy for spinal muscular atrophy (SMA) available to children aged two and older, teens, and adults. This one-time intrathecal injection offers a “game-changing” new treatment option for patients previously ineligible for gene therapy.
Novo Nordisk has officially filed for FDA approval of a higher, 7.2 mg dose of the weight-loss drug Wegovy®. Submitted under the expedited CNPV program, the new dose promises an accelerated review timeline. Phase 3 trial results indicate the 7.2 mg injection could offer significantly greater weight loss potential than the current standard dose.
Novo Nordisk has announced positive headline results from a Phase 2 clinical trial for its investigational drug, amycretin, showcasing its potential to be a next-generation [Read More…]
Novo Nordisk announced today that its blockbuster drug semaglutide failed to slow the progression of early-stage Alzheimer’s disease in two large-scale Phase 3 clinical trials, [Read More…]
Eli Lilly and Company is set to present “striking” new data at the 2025 ASH Annual Meeting, revealing a double victory for its BTK inhibitor, Jaypirca (pirtobrutinib). Results from two pivotal Phase 3 trials demonstrate that Jaypirca not only outperforms standard chemoimmunotherapy in first-line treatment but also meets non-inferiority benchmarks against the established drug ibrutinib. These findings could pave the way for Jaypirca to become a new standard of care for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) across multiple treatment settings.
The FDA has granted approval for PADCEV® plus KEYTRUDA® as a perioperative treatment for cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC). Clinical data reveals the combination reduces the risk of recurrence, progression, or death by 60% compared to surgery alone, marking a major shift in the standard of care.
Amgen’s groundbreaking drug IMDELLTRA has secured full FDA approval for extensive stage SCLC based on compelling Phase 3 data. It reduced the risk of death by 40%, offering a major advance for relapsed patients.
Merck has successfully launched a new, energy-efficient high-performance computer in Munich to accelerate research across its three sectors. Developed with Lenovo ThinkSystem servers featuring Neptune liquid cooling and hosted in an Equinix AI-ready data center, the hybrid cloud system enhances drug discovery, product development, and materials science while supporting Merck’s sustainability goals.
