FDA recently issued a complete response letter (CRL) to Gilead rejecting its New Drug Application (NDA) for HIV-1 treatment, lenacapavir.
The agency cited Chemistry Manufacturing and Controls (CMC)...
Clinical trials are an integral part of new product discovery and development. These trials (or clinical studies) test and assess potential treatments such as drugs, medical devices, or biologics (vaccines, gene and cellular therapies,...
AstraZeneca Rare Disease and Alexion group recently closed a global collaboration and license agreement with Neurimmune AG for the investigational human monoclonal antibody, NI006.
NI006 is a...
The CDC Advisory Committee on Immunization Practices (ACIP) recently recommended Pfizer’s tick-borne encephalitis (TBE) vaccine, TicoVac, to prevent TBE in individuals one year and older.
ACIP...
Gilead recently announced one-year results from an ongoing Phase 2/3 CAPELLA trial evaluating its HIV-1 capsid inhibitor, lenacapavir, in individuals with multi-drug resistant HIV.
The trial...
Merck recently announced that Keytruda, combined with chemotherapy and followed by Keytruda as monotherapy, prolonged event-free survival compared to chemotherapy followed by placebo in patients with...
AstraZeneca recently announced that its combination chemotherapy treatment improved radiographic progression-free survival (rPFS) compared to standard-of-care for metastatic castration-resistant...
Gilead recently announced that its COVID-19 treatment, remdesivir, retained antiviral in vitro activity against variants of concern, including Alpha, Beta, Gamma, Delta, and Omicron.
Researchers...
Abbott recently announced the world's first implant of a dual-chamber leadless pacemaker system as part of its Aveir DR i2i pivotal clinical trial.
The prospective investigational study will...
Pfizer and Valneva recently announced further positive results from the Phase 2 clinical trial evaluating their Lyme disease vaccine candidate, VLA15.
The trial, VLA15-221, enrolled 294 healthy adult...
Personalized immunotherapy from an individual’s tumor-fighting immune cells could potentially treat metastatic breast cancer, according to a study from the National Cancer Institute’s...
CVS Health and Medable recently collaborated to expand clinical trial access and engagement for patients at select MinuteClinic locations.
The collaboration will combine Medable’s software...
Modern and IAVI recently dosed the first two patients in a clinical trial of experimental HIV vaccine antigens at the George Washington University (GWU) School of Medicine and Health Sciences.
The...
FDA recently expedited approval of Gilead’s new drug application for its COVID-19 treatment, Veklury (remdesivir).
The agency expanded the drug to non-hospitalized adults and adolescent patients...
AstraZeneca recently announced that Imfinzi combined with standard-of-care chemotherapy significantly improved overall survival and progression-free survival in patients with advanced biliary tract...
The National Institutes of Health (NIH) recently launched the first phase of Neuromod Prize, a $9.8 million competition to accelerate the development of neuromodulation therapies.
Neuromodulation...
The Center for Breakthrough Medicines (CBM) and the University of Pennsylvania Gene Therapy Program (GCP) recently collaborated to advance the discovery and manufacturing of gene therapies.
The...
Pfizer recently announced that its COVID-19 treatment, Paxlovid, maintained plasma concentrations many-fold times higher than the amount required to prevent the Omicron variant from replicating in...
GSK recently appointed Tony Wood as chief executive officer (CSO), replacing current CSO Hal Barron.
Wood, a highly respected scientist and one of the world’s pre-eminent chemists, has over 30...
Bristol Myers Squibb and Century Therapeutics recently collaborated to develop and commercialize up to four engineered natural killer (iNK) and/or allogeneic cell therapies for hematologic malignancies...
