Don Tracy, Associate Editor

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.

Clearance of ASC50 paves the way for a Phase I trial in patients with mild-to-moderate plaque psoriasis.

Results from the Phase II WILLOW trial show that enpatoran achieved a statistically significant dose-response and clinically meaningful reduction in disease activity in cutaneous and systemic lupus erythematosus with active rash.

Positive feedback was based on Phase III AQUILA trial results, which showed a significant clinical benefit with Darzalex Faspro in patients with high-risk smoldering multiple myeloma.

Leandro Boer, MD, PhD, VP, US general medicines, Amgen, discusses the company's nationwide push to reduce cardiovascular risk through free LDL-C testing, public-private partnerships, and implementation science initiatives—all aimed at cutting CV events in half by 2030.

Under terms of the deal, Pfizer will gain rights to develop, manufacture, and commercialize SSGJ-707 outside of China.

Previously granted Emergency Use Authorization, Nuvaxovid is now available for individuals over 12 years of age.

Acquisition includes INZ-701, a late-stage enzyme replacement therapy targeting ectonucleotide pyrophosphatase/phosphodiesterase 1 deficiency.

Deal includes 23andMe’s Biobank, Personal Genome Service, Total Health, and research services operations.

Leandro Boer, MD, PhD, VP, US general medicines, Amgen, explains why seamless communication and treatment continuity across primary care, cardiology, and rehabilitation are critical to improving outcomes and preventing care gaps for cardiovascular patients.