Update

Implicity, a leading provider of remote patient monitoring and cardiac data management solutions, has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its innovative algorithm, SignalHF*. This groundbreaking algorithm, integrated into Implicity’s remote monitoring solution, is designed to assess the risk of future heart failure events based on comprehensive patient data….

Amgen and AstraZeneca disclosed the outcomes of the Phase 2a COURSE trial assessing Tezspire® (tezepelumab-ekko) in individuals with moderate to very severe chronic obstructive pulmonary disease (COPD), irrespective of their baseline blood eosinophil counts (BEC), emphysema, chronic bronchitis, or smoking history. Although the primary results did not achieve statistical significance, with a 17% numerical reduction…

The World Health Organization (WHO) has unveiled its updated Bacterial Priority Pathogens List (BPPL) for 2024, spotlighting 15 families of antibiotic-resistant bacteria classified into critical, high, and medium priority categories. This initiative aims to steer research and development efforts towards combating antimicrobial resistance (AMR), a global health crisis exacerbated by the misuse of antibiotics. Critical…

Amgen’s IMDELLTRA™ (tarlatamab-dlle) has gained FDA approval for treating adult patients with extensive-stage small cell lung cancer (ES-SCLC) post platinum-based chemotherapy progression. This milestone reflects a significant advancement, offering hope to a patient population with limited treatment options. The approval is based on compelling data from the Phase 2 DeLLphi-301 trial, showcasing IMDELLTRA’s efficacy in…

Merck, also known as MSD outside the United States and Canada, is set to unveil a wealth of data at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, spanning various oncology medicines and pipeline candidates targeting over 25 types of cancer. These presentations highlight Merck’s ongoing commitment to advancing cancer research…

Diasorin recently announced that the US Food and Drug Administration has granted 510(k) marketing clearance for their updated molecular respiratory panel, now including SARS-CoV-2 detection. The NxTag Respiratory Pathogen Panel v2, based in Saluggia, Italy, utilizes multiplex PCR to identify 19 viral and two bacterial targets in nasopharyngeal swab samples from patients displaying respiratory symptoms….

Seegene , a leading South Korean PCR molecular diagnostics company, has entered a strategic alliance with Springer Nature, publisher of the prestigious journal, Nature. Aligned in their mission to advance scientific discovery and combat diseases, this alliance aims to accelerate PCR diagnostic testing across various disease areas. The collaboration leverages the expertise of both parties…

Bristol Myers Squibb has received accelerated approval from the U.S. Food and Drug Administration (FDA) for Breyanzi® (lisocabtagene maraleucel; liso-cel), a CAR T cell therapy targeting CD19, to treat adult patients with relapsed or refractory follicular lymphoma (FL) who have undergone two or more prior lines of systemic therapy. This approval, based on response rate…

The Indian Council of Medical Research (ICMR) has issued a Generic Concordance Study Protocol aimed at evaluating tuberculosis (TB) detection technologies. This protocol seeks to establish the agreement between two iterations of an approved molecular TB detection technology. Through a cross-sectional approach, it aims to ascertain the concordance in identifying both TB and drug-resistant TB…

Bayer has announced the commencement of dosing in a Phase I clinical study for 225Ac-PSMA-Trillium (BAY 3563254), a novel targeted alpha therapy aimed at treating advanced metastatic castration-resistant prostate cancer (mCRPC). This investigational candidate, utilizing actinium-225, features a unique PSMA-targeting small molecule with a customized albumin-binding component. The study, identified as NCT06217822, will focus on…