A planned analysis of the KEYNOTE-942/mRNA-4157-P201 clinical trial found that at a median follow-up of approximately three years, adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Keytruda continued to show a clinically meaningful improvement in recurrence-free survival in patients with resected high-risk melanoma.
Trial findings show Welireg lowered the risk of disease progression or death compared to Afinitor in patients with advanced renal cell carcinoma whose disease progressed following treatment with a PD-1 or PD-L1 inhibitor and a TKI.
An evolving payer and commercial landscape post-COVID-19 pandemic, increasing regulatory complexity, and the discovery of new treatments with smaller patient populations are all factors impacting the research, development, and launch of new pharmaceutical products.
This is the first FDA approval of a therapy indicated to decrease the risk of relapse in pediatric patients with high-risk neuroblastoma.
Pfizer's $43 billion deal to acquire Seagen will significantly bolster its current oncology portfolio with Seagen’s late-stage development programs and expertise in antibody-drug conjugates.
MAPS Public Benefit Corporation has submitted a new drug application to the FDA for MDMA (midomafetamine capsules) for use with psychological intervention to treat post-traumatic stress disorder.
Deal includes Icosavax’s protein virus-like particle platform technology, which could significantly improve treatments to protect against severe infectious diseases.
BL-B01D1 is a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate currently being evaluated in the global, multi-center Phase I BL-B01D1-LUNG101 trial in patients with metastatic or unresectable non-small cell lung cancer.
Women within underserved populations with an endometrial, ovarian, or cervical cancer diagnosis were found to be underrepresented in trials.
V940 (mRNA-4157) to be evaluated in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer.
Phase II open-label, non-comparative, multicenter clinical trial shows Cresemba is effective in pediatric patients as young as 1 year of age with invasive aspergillosis and invasive mucormycotic.
Casgevy, which was approved along with Lyfgenia, is the first approval for a novel genome editing technology for sickle cell disease, which represents a significant advancement in gene therapy.
Recent study proposes consensus-based extension to the Consolidated Standards of Reporting Trials 2010 Statement for factorial trials.
PrEPVacc halts study of experimental HIV vaccine regimens and a new form of oral pre-exposure prophylaxis.
Aligning best practices in eCOA and ePRO within today’s evolving technology ecosystem.
How the Medical Information Data Uses For AI Semantic Analysis tool is saving pharma valuable time and resources in identifying data points.
KEYLYNK-008 trial finds that Keytruda in combination with chemotherapy followed by Keytruda plus Lynparza did not produce an improved overall survival benefit in patients with metastatic squamous non-small cell lung cancer.
How can we combat the sense of urgency our professional lives bring?
Decentralized clinical trials have the potential to expand the number of people who can benefit from clinical trials while accelerating therapies to more patients in need.
Clinical trials demonstrated superiority of Fabhalta to anti-C5s in hemoglobin improvement in the absence of transfusions and transfusion avoidance rate, showing clinically meaningful hemoglobin-level increases without the need for blood transfusions in patients with paroxysmal nocturnal hemoglobinuria.
Johnson & Johnson’s TAR-200 is currently in clinical trials for patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer who are ineligible for or elected not to receive bladder removal surgery.
Opdivo in combination with cisplatin-based chemotherapy shows durable responses and improved survival for patients with metastatic urothelial carcinoma.
Research shows GenAI has greater potential for a more immediate impact than previous digital technologies implemented in healthcare.
Pirtobrutinib (Jaypirca) is a next-generation, highly selected, non-covalent BTK inhibitor that has shown nanomolar potency against wild-type and C481-mutant BTK in cell and enzyme assays.
Despite regulatory guidance, disability status is frequently unreported or overlooked in trial design.
Supplemental Biologics License Application submission based on data from the Phase 3 KEYNOTE-A39 trial comparing Keytruda plus Padcev with chemotherapy of gemcitabine plus cisplatin or carboplatin.
FDA grants to expedite review of zotatifin plus Faslodex (fulvestrant) and Verzenio (abemaciclib) for patients with ER–positive, HER2-negative advanced or metastatic breast cancer.
Included in the FDA warning were levetiracetam, under the brand names Keppra and Keppra XR; Elepsia XR; Spritam; and clobazam, under the brand names Onfi and Sympazan.
DREAMM-7 was a Phase 3, multicenter, open-label, randomized trial analyzing the efficacy and safety of Blenrep plus bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma previously administered at least one prior line of treatment.
KRP203 (mocravimod) is intended to improve outcomes after hematopoietic stem cell transplantation for the treatment of hematologic malignancies.
