News

Pegloticase (Krystexxa; Amgen) is approved to treat chronic gout in adults who fail to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors.

By taking on tasks such as clinical trial management, logistics, statistics, and data management, contract research organizations have helped expand the capabilities of their sponsor partners and accelerate drug development timelines.

Ongoing phase 1 dose-escalation trial of KO-2806 (FIT-001) for the treatment of patients with KRASG12C-mutated non-small cell lung cancer expected to begin dosing patients in combination with adagrasib by mid-2024.

The handling of payments is frequently an aspect of contract research organizations work that goes underappreciated and undervalued, despite its critical importance.

R&D teams need to accelerate how they conduct their research, get to a material, and get to market.

The newly approved Alinity m high risk human papillomavirus (HPV) assay is indicated to detect HPV and for use in routine cervical cancer screening per professional medical guidelines.

New laws leave consumers unprotected against third parties accessing their genetic data.

The FDA placed a partial hold on a phase 1 trial for the Bruton tyrosine kinase degrader NX-2127 for the treatment of patients with relapsed/refractory B-cell malignancies.

There is an expanding array of potential antibody-based treatment options, such as bispecific or multispecific antibodies, that show promise in addressing conditions such as cancer, engineered antibody fragments, or even antibody-drug conjugates.

Phathom Pharmaceuticals announced that it anticipates vonoprazan (Voquenza) to be commercially available by December 2023.

SLS009 is a novel CDK9 inhibitor under investigation for the treatment of relapsed/refractory peripheral T-cell lymphomas.

Exagamglogene autotemcel (exa-cel) has shown the potential to be a landmark therapy in preventing episodes of excruciating pain among patients with sickle cell disease.

The branded form of secukinumab is currently the only FDA-approved fully human biologic that directly inhibits interleukin-17A.

Abatacept is indicated across multiple inflammatory conditions, including for the treatment of adult patients with moderately to severely active rheumatoid arthritis, pediatric patients with moderately to severely active polyarticular juvenile idiopathic arthritis, and active juvenile psoriatic arthritis.

Furmonertinib is in development for the treatment of advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations.

The FDA granted Wezlana with interchangeable designation after clinical trials found no clinically significant differences in safety and efficacy for the indicated conditions across multiple inflammatory diseases.

The approval of pembrolizumab (Keytruda; Merck) combined with gemcitabine and cisplatin for the treatment locally advanced unresectable or metastatic biliary tract cancer is the sixth sixth indication for the anti-PD-1 therapy for gastrointestinal cancers.

Collaboration provides both organizations opportunities to accelerate growth, streamline processes, and enhance data integrity.

Findings offer promising implications for neuroscience clinical trials and future treatments, company says.

Gill discusses her continuing work to transform clinical trials and improve the patient experience through DCTs.

Companies aim to simplify access to informative patient care data.

How pharma companies can reduce the risk of failure with AI-based innovations.

Wearable sensors and remote monitoring technology can help HCPs monitor and manage COPD more effectively.

Organizations aim to advance precision oncology and biomarker-driven research.

Support to focus on two double-blind Phase IIIb clinical studies in the Democratic Republic of Congo and Cote d’Ivoire.

Initiative aims to reduce cancer mortality rates by 50% in the next 25 years.

Mixture to be used for central nervous system clinical trials.

Collaboration to focus on enhancing physician engagement in clinical trials and cancer research.

The ACT EU initiative aims to develop the European Union further as a competitive center for innovative clinical research.

Treatment facility to be the first to evaluate Deltacel for patients with non-small cell lung cancer.