R&D/Clinical Trials

The era of big pharma as product-first companies must end, as services become the larger priority.

The biologics license application for afamitresgene autoleucel, an engineered T-cell receptor drug, was assigned a PDUFA date of August 4, 2024.

BST02 is the first tumor-infiltrating lymphocyte therapy for the treatment of all types of liver cancer to have advanced to the clinical trial stage.

DELFI-Tumor Fraction assay was developed to improve noninvasive assessment of tumor burden and monitoring of treatment efficacy and resistance in patients with advanced cancers.

Rusfertide is currently in a pivotal Phase III clinical trial as a potential first-in-class treatment for polycythemia vera.

Vabysmo is the first bispecific antibody approved to treat ocular conditions such as diabetic macular edema and wet age-related macular degeneration.

Including patient and family feedback in our discussions will help shape our understanding of their perception of provided care and services and how we operate as a whole.

Darzalex Faspro has previously been approved by the FDA for eight indications in multiple myeloma.

Approval sought for Padcev (enfortumab vedotin) plus Keytruda (pembrolizumab) for the first-line treatment of adults with previously untreated locally advanced or metastatic urothelial cancer, which would be the first approved combination alternative to platinum-containing chemotherapy for this patient population.

This is Takeda's second approval in chronic inflammatory demyelinating polyneuropathy this month after the FDA approved HyQvia to protect against relapse of neuromuscular disability and impairment in this patient population.

SRP-5051 administered every four weeks produced higher increases in dystrophin and exon skipping compared to eteplirsen dosed weekly in patients with Duchenne muscular dystrophy amenable to exon 51 skipping.

More than 1600 trials are currently evaluating Keytruda across a range of cancer types and treatment settings.

Enhertu has been approved by the FDA for indications in breast cancer, non-small cell lung cancer, and gastroesophageal junction adenocarcinoma.

Study finds that individuals who took GLP-1 agonists for a long duration had a lower risk of going on to develop more severe forms of liver disease, including cirrhosis and liver cancer.

Phase IIIb trial of Tremfya demonstrated rapid improvements in multiple areas of scalp psoriasis at 16 weeks.

Obecabtagene autoleucel is chimeric antigen receptor T-cell therapy under evaluation for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia.

The EVOKE-01 trial compared Trodelvy with docetaxel for the treatment of patients with metastatic or advanced non-small cell lung cancer who progressed on or following platinum-based chemotherapy and checkpoint inhibitor therapy.

NK010 is reportedly the first Chinese trial of its kind to be approved by the FDA.

McCloskey discusses the steps that drug developers can take to ensure better CLD outcomes in 2024.

The Osteoboost device has been shown to slow the loss of bone strength and density in postmenopausal women with osteopenia.

Opdivo plus Yervoy shows promise in treating patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer.

Study reportedly demonstrates the encouraging safety profile of satri-cel, the first autologous Claudin18.2 CAR T cell therapy.

Today's FDA approval amends a previously granted accelerated approval for Balversa (erdafitinib) to treat patients with metastatic urothelial carcinoma whose tumors harbor FGFR3 or FGFR2 alterations following prior platinum-based chemotherapy.

Analytics capabilities are no longer a nice-to-have, but a necessity to build and maintain a successful business and competitive edge.

Lutathera plus long-acting release octreotide lowered the risk of disease progression or death by 72% in patients with somatostatin receptor-positive well-differentiated grade 2/3 advanced gastroenteropancreatic neuroendocrine tumors.

Novocure’s tumor-treating fields plus standard-of-care therapies is under evaluation in patients with non-small cell lung cancer following disease progression on or after platinum-based treatment.

Pivmecillinam has already been approved in Europe to treat uncomplicated urinary tract infections.

NX-5948 is under evaluation for for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma following at least two lines of therapy that includes a BTK inhibitor and a BCL2 inhibitor.

Bloomlife’s MFM-Pro is a prescription-based wearable device that can track the maternal and fetal heart rate.

HyQvia is the only subcutaneous immune globulin infusion that can be administered once per month.