Approval was based on results from the Phase II TRUST-I and TRUST-II trials, which demonstrated confirmed overall response rates of up to 90% in patients treated with Ibtrozi for locally advanced or metastatic ROS1-positive non-small cell lung cancer.
Delivered as a once-daily 30 mg/mL IV bolus injection over 15 seconds, Xifyrm can be used alone or alongside non-NSAID analgesics as part of a multimodal pain strategy.
Regulatory action was based on data from the Phase III IMforte trial, which showed that Zepzelca plus Tecentriq significantly extended both progression-free survival and overall survival in patients with extensive-stage small cell lung cancer.
Results from a first-in-human Phase Ia/Ib trial show that LY4170156 demonstrated a notably high overall response rate in women with heavily pre-treated, platinum-resistant ovarian cancer.
Ron Lanton, Partner, Lanton Law, discusses the constitutional and statutory challenges facing the President’s use of executive orders to implement international drug pricing models such as the Most Favored Nation, highlighting the ongoing debate over separation of powers and congressional authority.
Approval of Enflonsia was based on data from the Phase IIb/III CLEVER trial, which showed a 60.5% reduction in medically attended lower respiratory infections and an 84.3% reduction in respiratory syncytial virus-related hospitalizations.
Early Phase I results for JNJ-79635322 demonstrated an 86.1% overall response rate in heavily pretreated multiple myeloma patients, including a 100% response in those naïve to B-cell maturation antigen and GPRC5D therapies.
Widaplik marks the first and only FDA-approved triple combination medication that can be used as an initial therapy for patients with hypertension who require multiple drugs to reach their blood pressure reduction goals.
Ron Lanton, Partner, Lanton Law, outlines how the MFN executive order may face significant legal challenges from the pharmaceutical industry, citing concerns over due process, intellectual property, and regulatory overreach.
FDA concluded that AXS-14’s New Drug Application was not sufficiently complete for substantive review, citing concerns with one of two clinical trials in fibromyalgia patients.
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.
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.
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 monthly roundup of business and people news in the pharmaceutical industry.
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.
Approval of Nucala marks the first biologic approved for chronic obstructive pulmonary disease patients with blood eosinophil counts as low as ≥150 cells/μL.
As the FDA’s ban on mass compounding of semaglutide takes effect, Novo Nordisk introduces discounted pricing and new patient resources to ensure safe access to Wegovy.
Approval of Susvimo marks the first continuous delivery therapy indicated for diabetic retinopathy.
Deal includes VG-3927, a first-in-class TREM2 agonist aimed at advancing next-generation Alzheimer disease therapies.
