AstraZeneca’s Alexion will fully acquire the remaining equity in Caelum Biosciences for the company’s first-in-class fibril-reactive monoclonal antibody (mAb) to treat rare disease light...
SAS and the University of North Carolina at Chapel Hill (UNC-Chapel Hill) recently partnered to transform the antiviral drug development process and prevent infectious disease threats from turning into...
Johnson & Johnson recently announced that a booster shot of its COVID-19 vaccine elicited 94 percent protection against coronavirus in a Phase 3 clinical trial.
The largest real-world...
Johnson & Johnson recently announced that its Ebola vaccine regimen, Zabdeno and Mvabea, generated robust antibody immune responses in children and adults.
The Phase 3 EBOVAC-Salone clinical...
FDA recently granted Breakthrough Designation for Eli Lilly & Company and Boehringer Ingelheim’s diabetes drug, Jardiance, as an investigational treatment for adults with heart failure with...
Sanofi recently entered into a $1.9 billion pharma acquisition deal with Kadmon Holdings to strengthen the growth of its transplant business.
Under the terms of the agreement, Sanofi will continue to...
Pfizer recently initiated a Phase 3 clinical trial evaluating the efficacy, immunogenicity, and safety of a single dose of its respiratory syncytial virus (RSV) vaccine candidate in adults.
The...
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...
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...
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...
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...
Pfizer recently entered into a $2.26-billion pharma acquisition deal with clinical-stage immuno-oncology company, Trillium, to strengthen its next-generation, investigational immuno-therapeutics...
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 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...
FDA amends the emergency use authorizations for both the Pfizer-BioNTech and Moderna COVID-19 vaccines to allow for an additional dose in immunocompromised individuals.
The agency determined that the...
Moderna recently dosed the first participant in the Phase 1 study of its autoimmune mRNA candidate, mRNA-6231, to expand regulatory T-cells.
The trial is the first in-human, dose-escalation study to...
