R&D/Clinical Trials

Supplemental Biologics License Application for lisocabtagene maraleucel (Breyanzi) seeks to expand the current indication include the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who were previously treated with a BTKi and BCL2i.

Adalimumab-bwwd (Hadlima; Samsung Bioepis Co., Ltd. and Organon & Co.) is seeking to become the third Humira biosimilar deemed interchangeable with the reference product.

Adzynma is the first approved genetically engineered protein product for the treatment of patients with congenital thrombotic thrombocytopenic purpura.

Solomon discusses new ways that researchers are fighting against bacterial resistance to medications.

A look into the potential effect of psychedelic drugs on various illnesses, such as mental health conditions.

FDA restricts use of pembrolizumab (Keytruda) combination in the treatment of gastric cancer to patients with certain tumor types.

Incidence rates have grown for leptomeningeal metastasis, a rapidly progressing and fatal complication of several cancers.

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 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.

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

Webinar Date/Time: Thursday, December 7, 2023 at 10am EST | 7am PST | 3pm GMT | 4pm CET

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.

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.

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 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.

In the ever-evolving landscape of healthcare, it's vital for organizations to take steps toward bridging the gap between their clinical and marketing teams.

Surge acted as a precursor for the RSV-marketed drug landscape in 2023, says GlobalData.

Webinar Date/Time: Tue, Nov 28, 2023 10:00 AM EST | 9:00 AM CT | 3:00 PM GMT | 4:00 PM CET

Webinar Date/Time: Tue, Nov 14, 2023 10:00 AM EST | 9:00 AM CT | 3:00 PM GMT | 4:00 PM CET

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

Clinical studies are increasingly designed to satisfy evidentiary needs.

In this Q&A with Pharmaceutical Executive®, Andrew Hopkins, founder and CEO of Exscientia, reveals how artificial intelligence (AI) is currently being utilized in the pharma industry, predictions for where AI can be implemented in the future, and what pharma fears most about AI.

The current vaccine pipeline brings promise of significant global health advancements—yet development gaps remain, and the future delivery challenges must be considered.

Companies that understand the regulatory environment in Europe can keep their trials on budget and on schedule.

Webinar Date/Time: Tue, Oct 31, 2023 10:00 AM EDT | 9:00 AM CT | 3:00 PM BST | 4:00 PM CEST

Webinar Date/Time: Tuesday, October 24th, 2023 at 10am EDT | 7am PDT | 3pm BST | 4pm CEST

Webinar Date/Time: Tue, Oct 17, 2023 10:00 AM EDT | 9:00 AM CT | 3:00 PM BST | 4:00 PM CEST