EMPEROR-Preserved phase III trial of Jardiance shows efficacy in heart failure – Eli Lilly + Boehringer

Jardiance (empagliflozin), from Eli Lilly and Boehringer, reduced the risk for the composite primary endpoint of cardiovascular death or hospitalization for heart failure and slowed kidney function decline in adults with heart failure with left ventricular ejection fraction (LVEF) over 40% regardless of chronic kidney disease status at baseline, according to findings from a new prespecified sub-analysis of the EMPEROR-Preserved […]

Update on the phase IV confirmatory study of Aduhelm for Alzheimer’s disease – Biogen + Eisai

Biogen Inc. and Eisai Co., Ltd. provided an important update on the continuing progress of the Phase IV post-marketing confirmatory study of Aduhelm (aducanumab-avwa) 100 mg/mL injection for intravenous use in Alzheimer’s disease. The companies anticipate submitting the final protocol for review to the FDA in March 2022, with the initiation of patient screening in May 2022. The study is […]

AbbVie provides update on Rinvoq for the treatment of rheumatoid arthritis in the U.S

AbbVie announced an update to the U.S. Prescribing Information and Medication Guide for Rinvoq (upadacitinib) for the treatment of adults with moderate to severe rheumatoid arthritis (RA). This update follows a Drug Safety Communication (DSC) issued on 1 September, 2021 by the FDA following its final review of the post-marketing study, ORAL Surveillance, evaluating Xeljanz (tofacitinib) in patients with RA. […]

European Commission approves Lenvima + Keytruda to treat endometrial carcinoma – Eisai + Merck Inc.

Eisai Co., Ltd. and Merck Inc., announced that the European Commission has approved the combination of Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus Keytruda, the anti-PD-1 therapy from Merck Inc., for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy […]

Nanoparticle-formulated drug combination is effective in medulloblastoma, a pediatric brain tumor

UNC Lineberger Comprehensive Cancer Center researchers have demonstrated that a novel combination of two drugs that act as targeted inhibitors, delivered in a nanoparticle formulation, extend the survival of mice with medulloblastoma. The research team believes this laboratory success could be translated into a less toxic treatment for medulloblastoma, the most common malignant pediatric brain tumor. Advances such as this […]

INTRIGUE Phase III study of Qinlock fails to meet primary endpoint in gastrointestinal stromal tumor – Deciphera Pharmaceuticals

Deciphera Pharmaceuticals announced top-line results from the INTRIGUE Phase III clinical study of Qinlock (ripretinib) in patients with gastrointestinal stromal tumor (GIST) previously treated with imatinib. The study did not meet the primary endpoint of improved progression-free survival (PFS) compared with the standard of care. In the study, 453 patients were randomized 1:1 to either Qinlock 150 mg once daily […]

FDA grants Tentative Approval for Yutrepia to treat pulmonary arterial hypertension – Liquidia Corpn

Liquidia Corporation has announced that the FDA granted tentative approval for Yutrepia (treprostinil) inhalation powder, previously referred to as LIQ 861. Yutrepia is indicated for the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability in adult patients with New York Heart Association (NYHA) Functional Class II-III symptoms. Tentative approval indicates that Yutrepia has met all regulatory standards for […]

Phase III FURI study of ibrexafungerp shows positive clinical results in multiple fungal infections – Scynexis

Scynexis announced an oral presentation of analyses of interim data from its ongoing Phase III FURI study showing favorable clinical activity of oral Brexafemme (ibrexafungerp) in severe hospital-based fungal infections across multiple serious fungal infections. Data from an interim analysis of the combined data of 74 patients from the Phase III FURI clinical study evaluating oral ibrexafungerp for the treatment […]

New comprehensive phase III data show first-in-class Tremfya provided durable improvements in measures of psoriatic arthritis through two years – Johnson & Johnson

The Janssen Pharmaceutical Companies of Johnson & Johnson announced comprehensive efficacy and safety data from the DISCOVER–2 trial of Tremfya (guselkumab) were published in Arthritis & Rheumatology, representing the final results of the first two-year clinical trial investigating a selective interleukin (IL)-23 inhibitor therapy in active psoriatic arthritis (PsA). Results show a majority of Tremfya-treated biologic-naïve adult patients with active […]

Roche presents new data for Evrysdi at World Muscle Society (WMS) 2021 highlighting new advances for people living with rare neuromuscular disorders

Roche announced data from across its growing neuromuscular portfolio at the World Muscle Society (WMS) Virtual Congress 20 – 24 September 2021. The presentations included additional results from the RAINBOWFISH study, evaluating the efficacy and safety of Evrysdi (risdiplam) in babies with pre-symptomatic spinal muscular atrophy (SMA) from birth to six weeks of age and data. At WMS 2021, data […]