Clinical Trials

Pfizer (NYSE: PFE) is enrolling subjects in a study combining an investigational pneumococcal conjugate vaccine with a booster dose of its Pfizer-BioNTech COVID-19 vaccine. At present, COVID-19 and pneumococcal conjugate vaccines are among Pfizer’s bestsellers. The company expects COVID-19 vaccines to pull in $26 billion this year. Last year, the company’s Prevnar 13 pneumococcal 13-valent conjugate…

Americans will start receiving Johnson & Johnson‘s COVID-19 vaccine within the next 24 to 48 hours, J&J CEO Alex Gorsky told NBC’s Today this morning. FDA issued an EUA for J&J’s Ad26.COV2-S vaccine on Feb. 27, a day after an advisory panel unanimously recommended that the agency authorize the vaccine for adults 18 and over.…

In the early days of the pandemic, hopes were high that a vaccine could return society to normalcy. But now that FDA has authorized two vaccines, much of the general public is waiting for them to become broadly available. Some 4.5% of the U.S. population has been fully vaccinated as of Feb. 17, according to…

The pandemic has amplified the pressure pharmaceutical companies face to improve operational performance while also forcing them to accelerate innovation, clinical trials and production. All of this requires employees to work as efficiently as possible. Technology is available to meet these needs while also helping pharma companies respond to new worker safety challenges. Within pharma…

India is allowing reserved emergency use of the AstraZeneca (LON:AZN) COVID-19 vaccine and another from the domestic firm Bharat Biotech.  The country is producing both vaccines internally. Serum Institute of India has a contract to manufacture the AstraZeneca vaccine and has stockpiled between 40 and 50 million doses.  Covaxin, the vaccine from Bharat Biotech, was…

NIH has paused enrollment in three clinical trials for COVID-19 patients taking full doses of anticoagulants. The studies found that, for COVID-19 patients requiring intensive care unit support, anticoagulants did not reduce their need for organ support. Independent boards overseeing the trials could not rule out the potential for harm for such patients taking anticoagulants. …

Research groups throughout the world are considering whether the Bacillus Calmette-Guérin (BCG) tuberculosis vaccine can effectively slow the spread of the novel coronavirus.  Earlier this month, a group of Russian researchers analyzed roughly 100 studies that charted the virus’s spread worldwide. Regions that used the BCG vaccine had a lower infection rate than areas that…

The White House Coronavirus Task Force promised a swift rollout of COVID-19 vaccines — but one of a number of takeaways from its first briefing since July. The briefing yesterday gave the task force a chance to once again urge Americans to heed COVID-19 guidance while also providing an update on vaccines and therapeutics.   The…

A National Institutes of Health clinical trial has concluded that hydroxychloroquine had no clinical benefit for hospitalized COVID-19 patients. The Journal of the American Medical Association published the results from the blinded, placebo-controlled, randomized trial. The clinical trial, known as the “ORCHID” study, treated 479 symptomatic COVID-19 patients with hydroxychloroquine in 34 hospitals in the…

TrialScope has worked with EMD Serono, the North American branch of the healthcare business of Merck KGaA, Darmstadt, Germany, to launch a new website, https://clinicaltrials.emdgroup.com. This site is designed to educate and inform patients, caregivers, the public, patient advocacy groups and healthcare professionals (HCPs) about the clinical trial journey, as well as provide specific information…