Davy James

Phase III trial results show a greater proportion of children aged one to 11 years administered a weight-tiered higher dose of Dupixent achieved a significant improvement across multiple key disease measures for eosinophilic esophagitis compared to placebo.

Phase III SURMOUNT-OSA trial data show positive impact of tirzepatide in patients with moderate-to-severe obstructive sleep apnea and obesity.

Imfinzi (durvalumab; AstraZeneca) combined with chemotherapy led to a statistically significant and clinically meaningful improvement in event-free survival and overall survival compared with neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer.

Omnipod 5 Automated Insulin Delivery System shows improvements in blood glucose outcomes and overall quality of life among patients with type 2 diabetes.

Tremfya (guselkumab) subcutaneous induction therapy shows positive findings for the treatment of adult patients with moderately to severely active Crohn disease.

Columvi with gemcitabine and oxaliplatin (GemOx) achieved statistically significant and clinically meaningful outcomes treating relapsed or refractory diffuse large B-cell lymphoma compared to MabThera/Rituxan plus GemOx.

The FDA approved HyQvia earlier this year as a maintenance therapy to protect against relapse of neuromuscular disability and impairment in adult patients with chronic inflammatory demyelinating polyneuropathy.

Linvoseltamab was previously granted Priority Review by the FDA for adults with relapsed/refractory multiple myeloma who experienced disease progression following prior administration of at least three therapies.

Elrexfio is a BCMA-CD3-targeted bispecific antibody that the FDA granted accelerated approval in August 2023 to treat patients with relapsed or refractory multiple myeloma who were previously administered at least four lines of therapy.

Phase III NextCOVE trial shows Moderna’s next-generation, investigational SARS-CoV-2 vaccine mRNA-1283 achieved the primary efficacy endpoint of non-inferiorty compared with Spikevax in preventing COVID-19.

The Phase III BE MOBILE 1, BE MOBILE 2, and BE MOVING trials show Bimzelx, an IL-17A and IL-17F inhibitor, produced sustained suppression of inflammation over two years and improvements in quality of life among patients with active non-radiographic axial spondyloarthritis and ankylosing spondylitis.

Seladelpar is a first-in-class, oral, selective peroxisome proliferator-activated receptor-delta agonist that has been found to improve markers of liver function and pruritis in patients with primary biliary cholangitis.

GIP receptor and GLP-1 receptor agonist tirzepatide demonstrates superiorty to placebo in MASH resolution in patients with with stage 2 or 3 fibrosis.

Results from the Phase II PICCOLO trial show the promise of Elahere (mirvetuximab soravtansine; AbbVie) in heavily pre-treated patients with folate receptor-alpha positive, platinum-sensitive ovarian cancer.

Enhertu achieved statistically significant and clinically meaningful improvements in progression-free survival compared with standard-of-care chemotherapy among patients with HR-positive, HER2-low metastatic breast cancer.

Results from the Phase III CheckMate -9DW trial show Opdivo plus Yervoy produced a statistically significant and clinically meaningful improvement in overall survival compared with investigator’s choice of sorafenib or lenvatinib in the first-line treatment of unresectable hepatocellular carcinoma.

Tagrisso (osimertinib; AstraZeneca) reduced the risk of disease progression or death by 84% in patients with unresectable, stage III epidermal growth factor receptor-mutated (non-small cell lung cancer with tumors that harbor exon 19 deletions or exon 21 (L858R) mutations.

Results of the Phase III CheckMate -77T, CheckMate -816, and CheckMate -9LA trials show the potential of Opdivo to improve survival among patients with early and advanced stages of lung cancer.

Approval of Breyanzi (lisocabtagene maraleucel) to treat adults with relapsed or refractory mantle cell lymphoma was based on findings from the open-label, multicenter, pivotal TRANSCEND NHL 001 trial.

Dupixent (dupilumab) was previously granted priority review status as an add-on maintenance treatment for certain adults with uncontrolled chronic obstructive pulmonary disease.

Patients with locally advanced or metastatic non-small cell lung cancer who were previously administered at least one line of therapy showed superior overall survival compared to docetaxel.

Sarclisa (isatuximab-irfc) could become the first anti-CD38 therapy indicated in combination with bortezomib, lenalidomide, and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for a transplant.

Keytruda (pembrolizumab; Merck) plus chemotherapy administered as neoadjuvant treatment and then as monotherapy postsurgery produced a statistically significant improvement in overall survival in patients with high-risk early-stage triple-negative breast cancer.

Sotyktu (deucravacitinib; Bristol Myers Squibb) is an oral, selective, allosteric tyrosine kinase 2 inhibitor that produced clinically meaningful improvements in Psoriasis Area and Severity Index scores among adult patients with moderate-to-severe plaque psoriasis.

Once-weekly subcutaneous injection of CT-388 produced significant weight loss in healthy adults with obesity compared with placebo across 24 weeks in an early phase trial.

Leqembi (lecanemab-irmb) was previously granted fast track designation by the FDA for a subcutaneous version of the drug to treat Alzheimer disease in patients with mild cognitive impairment or the mild dementia stage of the disease.

In the Complete Response Letter to Dynavax, the FDA stated that the supplemental Biologic License Application based on findings from the Phase I HBV-24 trial lacked sufficient data to support a full evaluation of the efficacy or safety of a four-dose Heplisav-B regimen in adults on hemodialysis.

Trial data met the pre-specified futility criteria for the primary endpoint of recurrence-free survival with the combination of vibostolimab and Keytruda (pembrolizumab) in the adjuvant treatment of patients with resected high-risk melanoma.

Administrative constraints cause FDA to push back its review of data from a pivotal Phase III trial (NCT05127434), which demonstrated favorable clinical safety and efficacy for mRNA-1345, an investigational vaccine found to reduce the incidence of RSV-associated lower respiratory tract disease.

Findings from the Phase III KEYNOTE-B21 trial show that Keytruda (pembrolizumab) plus chemotherapy as adjuvant therapy, with or without radiotherapy, administered to patients with newly diagnosed high-risk endometrial cancer following surgery with curative intent did not achieve superiority in disease-free survival over placebo.