Davy James

EMPA-KIDNEY trial shows that two years of treatment with Jardiance (empagliflozin) significantly lowered the risk of chronic kidney disease progression and cardiovascular death, with lasting cardiorenal benefits up to one year after treatment ended.

Phase III GRAVITI trial results show Tremfya (guselkumab) administered subcutaneously provides significant clinical remission and endoscopic response at 48 weeks for patients with moderate to severe Crohn's disease, offering a promising new treatment option with both subcutaneous and intravenous induction routes.

Omvoh (mirikizumab) becomes the first IL23p19 antagonist to show multi-year, long-term sustained efficacy in both ulcerative colitis and Crohn disease, with Phase III trials showing high rates of clinical and endoscopic remission with a consistent safety profile.

Ebglyss (lebrikizumab-lbkz) shows significant efficacy in reducing skin symptoms and itch in moderate-to-severe atopic dermatitis patients, including those who previously discontinued Dupixent.

Respiratory syncytial virus (RSV) vaccine Arexvy shows strong immune responses in adults aged 18-49 with an elevated risk for RSV lower respiratory tract disease, including immunocompromised adults, suggesting the potential to expand the vaccine's use beyond its current approval in older age groups.

Data from the Phase III SOUL trial demonstrated that oral semaglutide (Rybelsus) significantly reduced major adverse cardiovascular events in patients with type 2 diabetes and cardiovascular or kidney disease, providing evidence for its cardiovascular benefits and supporting a potential label expansion.

Phase IV ELEVATUM trial results show that one year of treatment with Vabysmo significantly improved vision in underrepresented racial and ethnic groups with diabetic macular edema, supporting the drug's efficacy and safety across diverse populations.

The combination of islatravir (Merck) and lenacapavir (Gilead) demonstrated high efficacy in maintaining a 94.2% viral suppression rate in virologically suppressed adults with HIV after 48 weeks of treatment in a Phase II trial.

Merck's investigational monoclonal antibody, clesrovimab, shows significant efficacy in reducing respiratory syncytial virus-related infections and hospitalizations in infants, with a favorable safety profile.

The combination of Opdivo (nivolumab) plus chemotherapy significantly improved progression-free survival compared to Adcetris (brentuximab vedotin) plus chemotherapy in patients with advanced stage Hodgkin lymphoma, based on findings from the Phase III S1826 trial.

Real-world data presented at IDWeek 2024 show Apretude (cabotegravir long-acting) is more than 99% effective in preventing HIV infection, with high adherence rates, reduced stigma and anxiety, and broad acceptability.

Preliminary data from the Phase III IMforte trial show the combination of Zepzelca (lurbinectedin) plus Tecentriq (atezolizumab) significantly improved overall survival and progression-free survival in patients with extensive-stage small cell lung cancer.

Data from the RAINBOWFISH trial shows early treatment with Evrysdi (risdiplam) in pre-symptomatic infants with spinal muscular atrophy (SMA) leads to significant motor milestone achievements, such as standing and walking, as well as cognitive development typical of non-SMA children, without the need for permanent ventilation.

Tremfya (guselkumab) demonstrated superior endoscopic remission rates in both Crohn disease and ulcerative colitis, including biologic-naïve and biologic-refractory patients, according to Phase III clinical trial data.

Talzenna (talazoparib) with Xtandi (enzalutamide) produced a statistically significant improvement in overall survival among patients with metastatic castration-resistant prostate cancer, regardless of mutation status, making it the first combination of a PARP inhibitor and ARPI to achieve these results.

KEYNOTE-689 trial shows Keytruda (pembrolizumab) produced significantly improved event-free survival and major pathological response in patients with resected, locally advanced head and neck squamous cell carcinoma, marking the first Phase III trial to show meaningful results with an anti-PD-1 therapy in both the neoadjuvant and adjuvant settings.

Twice-yearly lenacapavir, a long-acting HIV-1 capsid inhibitor, reduced HIV infections by 96% in the Phase III PURPOSE 2 trial while showing superior efficacy over daily Truvada.

Findings from the BATURA Phase IIIb trial demonstrated that Airsupra (albuterol/budesonide) significantly reduced the risk of severe asthma exacerbations in patients with intermittent or mild persistent asthma compared to albuterol alone.

In the Phase II PATH-HHT trial, pomalidomide significantly reduced the severity of epistaxis and improved quality of life in patients with hereditary hemorrhagic telangiectasia, offering a potential treatment for the bleeding disorder, which currently lacks FDA-approved therapies.

Ziresovir is a potent, selective, orally bioavailable RSV F protein inhibitor, that has been shown to reduce viral load and the Wang Respiratory Score with a favorable safety profile in hospitalized infant patients with respiratory syncytial virus infection.

Proof-of-concept Phase II ARTEMIS-UC trial shows efficacy of investigational humanized monoclonal antibody tulisokibart in treating inflammatory bowel disease compared with placebo.

Beqvez (fidanacogene elaparvovec), a one-time gene therapy, was approved by the FDA in April 2024 to treat adults with moderate to severe hemophilia B.

Results from the Phase III CARTITUDE-4 trial show Carvykti (ciltacabtagene autoleucel) is the first and only cell therapy to show an overall survival benefit compared to standard therapies for patients with relapsed or lenalidomide-refractory multiple myeloma.

Phase III REGENCY trial results highlight potential of Gazyva/Gazyvaro (obinutuzumab) to improve outcomes in lupus nephritis patients, reducing progression to end-stage kidney disease.

Bristol Myers Squibb and 2seventy bio have ceased enrollment in the Phase III KarMMa-9 trial, stating that advances in induction therapies for newly diagnosed multiple myeloma have reduced the eligible patient population for the trial.

Ebglyss was approved by the FDA earlier this month to treat moderate-to-severe atopic dermatitis in patients aged 12 years and older who weigh at least 88 lbs.

Phase III KEYNOTE-522 trial data show Keytruda (pembrolizumab) plus chemotherapy lowered the risk of death by 34% compared to chemotherapy alone in patients with high-risk early-stage triple-negative breast cancer.

Niktimvo (axatilimab) gained FDA approval in August 2024 to treat graft-versus-host-disease in patients who did not achieve a response to at least two prior lines of systemic therapy.

Cabozantinib (Cabometyx, Cometriq) shows potential as a new standard of care for patients with advanced pancreatic neuroendocrine tumors and advanced extra-pancreatic neuroendocrine tumors in Phase III CABINET trial.

Results from the the Phase III NIAGARA trial show Imfinzi (durvalumab) is the first immunotherapy regimen to significantly extend overall survival in patients with muscle-invasive bladder cancer.