Medidata and Labcorp Drug Development recently entered into an agreement to expand decentralized clinical trial capabilities and digital biomarker discovery.
The companies will leverage Medidata...
Real world evidence (RWE) in pharmaceutical drug development analyzes real world data, such as electronic health records and data from wearable devices, to complement clinical trials data.
RWE...
Eli Lilly and Company recently announced that its prescription medicine, Jardiance, elicited a 21-percent relative risk reduction in death or hospitalization for heart failure patients compared to...
Moderna recently submitted initial data to the FDA to evaluate a booster dose of its COVID-19 vaccine, mRNA-1263, at the 50 microgram dose level.
The company will submit data to the European...
Black Americans are still significantly underrepresented in cardiovascular disease clinical trials, and enrollment rates have not improved over time, according to a new paper published in the Journal...
FDA recently approved the MicroTransponder Vivistim Paired VNS System (Vivistim System) to treat moderate to severe upper extremity motor deficits associated with chronic ischemic...
Merck recently announced that its pneumococcal 15-valent conjugate vaccine, Vaxneuvance, met key immunogenicity and safety endpoints in a Phase 3 clinical trial.
The PNEU-PED study enrolled...
COVID-19 convalescent plasma given to high-risk outpatients within one week of the onset of coronavirus symptoms does not prevent disease progression, according to a New England Journal of Medicine...
Johnson & Johnson recently announced that a booster dose of its COVID-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after...
Novartis recently announced that the Phase 3 clinical trial investigating its aggressive B-cell-non-Hodgkin lymphoma (NHL) treatment, Kymriah, did not meet its primary endpoint of event-free survival...
Johnson and Johnson recently announced that FDA approved an expanded peripheral artery disease (PAD) indication for its Xarelto vascular dose.
The indication will now include patients following recent...
AstraZeneca recently announced that its COVID-19 antibody combination, AZD442, reduced the risk of symptomatic coronavirus by 77 percent compared to placebo in a Phase 3 trial.
The randomized,...
FDA recently granted accelerated approval to GSK’s PD-1 blocking antibody drug, Jemperli, for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid...
FDA has granted full approval to Pfizer and BioNTech’s COVID-19 vaccine for individuals 16 years of age and older.
This vaccine, previously known as the Pfizer-BioNTech COVID-19...
Moderna recently announced that the first patient has received a dose in a Phase 1/2 study of its mRNA therapeutic, mRNA-3705, for methylmalonic acidemia (MMA).
The open-label landmark study...
FDA recently approved a new indication for chronic disease treatment, Xywav, intended for adults with idiopathic hypersomnia (IH).
The oral solution is already approved to treat cataplexy...
The World Health Organization (WHO) recently announced the next phase in its Solidarity trial, Solidarity PLUS, to test new COVID-19 drugs in hospitalized patients.
The trial will enroll...
The novel FDA drug approval process allows researchers to uncover the appropriate dosage for both children and adults, determine the best route of administration, and test for any drug interactions....
Novavax recently announced that a single booster dose of its COVID-19 vaccine, NVX-CoV2373, elicited a 4.6-fold increase in functional antibody titers six months after an initial two-dose...
