Results from the Phase III CORALreef HeFH and CORALreef AddOn studies demonstrated tatistically significant and clinically meaningful reductions in low-density lipoprotein cholesterol levels in patients treated with enlicitide decanoate for hyperlipidemia already on lipid-lowering therapies.
Results from the Phase II VLA1553-221 trial show that a full dose of Ixchiq demonstrated a 96.5% seroresponse rate in chikungunya-naïve children at day 180.
While the medications may reduce diet, the best results will be achieved by building healthy habits alongside the drugs.
Results from the Phase II C-144-01 trial showed that a single infusion of Amtagvi demonstrated a 31.4% objective response rate in patients with advanced melanoma previously treated with anti-PD-1 and targeted therapies.
Results from the Phase III ASCENT-04/KEYNOTE-D19 trial demonstrated that Merck’s Keytruda combined with Gilead’s Trodelvy reduced the risk of disease progression or death by 35% in patients with PD-L1–positive inoperable or metastatic triple-negative breast cancer.
Results from the Phase III SERENA-6 trial show that camizestrant, in combination with a CDK4/6 inhibitor, significantly reduced the risk of disease progression or death in patients with HR-positive, HER2-negative advanced breast cancer and emergent ESR1 mutations.
Results from the Phase III VERITAC-2 trial demonstrated that vepdegestrant reduced the risk of disease progression or death by 43% in patients with ER+/HER2- advanced or metastatic breast cancer harboring ESR1 mutations.
Approval was based on results from the Phase III ARANOTE trial, in which Nubeqa demonstrated a 46% reduction in the risk of radiographic progression or death when combined with androgen deprivation therapy, in patients with metastatic castration-sensitive prostate cancer.
New drug application submission was based on positive data from the Phase III GLISTEN trial, which demonstrated significant and sustained reductions in pruritus and related sleep disruption in patients treated with linerixibat.
Results from the Phase III AMPLITUDE trial of niraparib plus abiraterone acetate and prednisone demonstrated a statistically significant and clinically meaningful improvement in patients with metastatic castration-sensitive prostate cancer.
New data show that Uzedy significantly reduces relapse and healthcare utilization, while TEV-'749 has demonstrated strong efficacy with no post-injection delirium/sedation syndrome to date—advancing long-acting treatment options for schizophrenia.
In today’s environment, aligning the Target Product Profile with the appropriate Value Evidence Archetype is not just good practice, it is a strategic imperative.
Interim results from the Phase II COURAGE trial show that combining semaglutide with anti-GDF8 antibody trevogrumab preserves lean mass and enhances fat loss, offering a potential advancement in obesity treatment.
Approval was based on data from the Phase III NextCOVE trial, which demonstrated that mNEXSPIKE met non-inferiority criteria compared to the original Spikevax as a vaccine for COVID-19.
Major players including AbbVie, GSK, Sanofi, and Eli Lilly recently bolstered their R&D pipelines with a wave of acquisitions and alliances focused on pain, obesity, and neuroscience.
Under terms of the deal, both companies will co-develop and co-commercialize BNT327 for multiple solid tumors, with the option to pursue additional indications and combination therapies independently.
A Harvard Business School Healthcare Alumni Association Q&A with Aileen Fernandes, Chief Business Officer of Arcellx.
The pharmaceutical company will donate money for each strike-out made by the team’s pitcher for the remainder of the regular season.
The organization is targeting teens in rural areas of Georgia, Indiana, and Kentucky.
A monthly roundup of business and people news in the pharmaceutical industry.
The GMRLN plays an important role in identifying outbreaks early and providing the necessary support to control them.
For the treatment of locally advanced or metastatic EGFR-mutated non-small cell lung cancer, patritumab deruxtecan did not meet statistical significance for overall survival in the HERTHENA-Lung02 trial.
Arkstone Medical Solutions commissioned the study, which was conducted earlier this year in Peru.
The organization is providing trainers with information and education for how to coach clients taking the weight-loss medications.
In patients with first-line metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitors, Trodelvy (sacituzumab govitecan-hziy) achieved a statistically significant and clinically meaningful improvement in PFS compared to chemotherapy.
The organization was inspired to promote awareness for the disease in the wake of the former President’s diagnosis.
The move comes as FDA’s grace period for compounded GLP-1s comes to an end.
In a post-hoc analysis from the Phase III ARANOTE trial, new results show metastatic castration-sensitive prostate cancer patients treated with Nubeqa plus ADT experienced a clinically meaningful improvement in health-related quality of life and delayed pain progression.
The two companies first announced the merger back in March of this year.
In this Pharmaceutical Executive exclusive, Bob Jansen, David Shulkin, Gen. Paul Funk (Ret.), and Maj. Gen. Dennis LeMaster (Ret.)—members of the Federated Healthcare Advisory Panel—discuss how pharmaceutical companies can strengthen supply chain resilience, navigate policy shifts, and adopt a national security mindset.
