clinical trials

The rapid pace of development of COVID-19 vaccines and antibodies has redefined expectations for clinical trials. As SARS-CoV-2 variants such as Delta continue to fuel the epidemic, the industry must continue to ensure testing and clinical trials stay ahead of mutations. To get a clearer sense of what the ramifications of this accelerated development will…

A great many new and varied approaches to clinical trial management have gained ground during the COVID-19 pandemic through the help of virtualization tools, strong partnerships, and regulatory guidance. Despite the upheaval this year and last, there appears to be a silver lining. The systemic changes have enabled remarkably quick development in adapting trials to…

The National Institutes of Health (NIH) has launched a study to gauge the antibody response of a third dose of mRNA COVID-19 vaccine in patients with autoimmune disease. Participants in the study had an insufficient immune response to the primary series of vaccination. The Phase 2 study will also test the impact of pausing immunosuppressive…

Cyberattacks targeting the pharma industry have ramped up during the pandemic, and insider threats and nation-state attacks are also on the rise. Meanwhile, the average cost of a pharma breach in 2021 is $5.04 million, according to the IBM-sponsored Ponemon Institute’s Cost of a Data Breach Report. For context, an average data breach incurs damages of $4.24…

BYOD — “bring your own device” — became a common term in tech circles a decade ago. Now with primary care doctors playing a growing role in clinical trials, the provider of decentralized clinical research software Curebase (San Francisco) aims to popularize the concept of “BYOP” — “bring your own physician.” That is, the company is…

As a result, Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) have agreed to expand clinical trials of their vaccines in children aged five to 11 before seeking emergency use authorization. In April, Israel first reported suspected cases of heart inflammation in recipients of the COVID-19 vaccine from Pfizer and its partner BioNTech. Since then, FDA has substantiated the risk of myocarditis,…

A couple of years ago, mRNA vaccines remained at the research stage. Now, they are among the best-selling pharmaceutical products with Pfizer (NYSE:PFE), BioNTech (NSDQ:BNTX) and Moderna (NSDQ:MRNA) dominating the market. However, that could change in the long run as a growing number of companies develop next-generation mRNA COVID-19 vaccines, which promise to be more effective…

The Dublin-based pharmaceutical R&D firm APC Ltd has launched a ‘Global Centre of Excellence for Vaccine and Advanced Therapeutic Research and Manufacturing.’ The result of a €25 million investment, the new facility will staff 120 new employees. The facility will have the capacity to produce hundreds of millions of doses of vaccines (including for COVID-19)…

Johnson & Johnson (NYSE:JNJ) has announced that a single shot of its COVID-19 vaccine offers significant protection against the transmissible Delta variant. The vaccine also provides an immune response lasting at least eight months. The announcement coincides with the company filing two preprint studies to bioRxiv. The first analyzes blood samples from eight patients in…

Some two week after announcing that its COVID-19 vaccine had an interim efficacy of 47% in a Phase 2b/3 trial, CureVac (NSDQ:CVAC) appeared to be regaining its footing. After announcing the final results of the trial, however, its stock fell approximately 12% on July 1 in mid-day trading. In the trial, the final vaccine efficacy…

COVID-19 disrupted oncology clinical trials. More than a year into the pandemic, drug developers and regulators, including FDA, are also looking for ways to catalyze clinical trial innovation with AI and other tech. The FDA has been “vigilant as they always are to make sure that there is strong science, but they are much more…

Twelve years. That’s the average amount of time it takes for a viable therapeutic to make it from the research stage to approval for market. In that time, 2.4 million Americans will suffer the effects of severe acute pancreatitis, many of which can be long-lasting and debilitating. Roughly 240,000 of these patients will die as…

Pfizer (NYSE:PFE) and its German partner BioNTech (NASDAQ: BNTX) will proceed with a COVID-19 vaccine trial involving as many as 4,500 children. The trial will significantly reduce the 30-mg dose that adults and adolescents receive. Investigators will administer a 10-µg dose to children aged 5 to 11 and give those aged six months to five years…

While drug developers continue to develop promising investigational cancer drugs, conducting clinical research in oncology remains difficult. Here’s how AI-enabled software can help.  The statistics on inadequate trial recruitment and endemic challenges in oncology clinical trials are well known. They have only gotten worse over the past 20 years. While the number of cancer treatments…

Regeneron (NSDQ:REGN) has announced that the FDA has signed off on a 1,200 mg subcutaneous or intravenous dose of its REGEN-COV antibody cocktail. The quantity is half of the initially authorized dose. The agency had previously authorized a 2,400 mg dose of the vaccine, including a combined dose of 1,200 mg of Casirivimab and 1,200…

An article recently published in JAMA concluded that two inactivated COVID-19 vaccines from Sinopharm (OTCMKTS: SHTDY) were 72.8% and 78.1% effective, respectively, based on interim Phase 3 study results.   The lower figure refers to the protection from a COVID-19 vaccine based on two 5-µg doses based on the SARS-CoV-2 isolate WIV04 complete genome. The second vaccine in the…

While the question of when the vaccinated public will require a COVID-19 booster remains unclear, some long-term care advocates are pushing for guidance to avoid a potential resurgence in infections in the fall and winter.  Nursing home residents were among the first to receive COVID-19 vaccines. Providing boosters to the demographic is vital to prevent…

Healthcare workers have administered almost 288 million doses of COVID-19 vaccines in the U.S., which now has more than enough vaccine for the present demand.  Against that backdrop, FDA has released updated emergency use authorization (EUA) guidelines for COVID-19 vaccines that state the agency could decline some future EUA requests. “For the remainder of the current pandemic,…

A Phase 2a-b trial found that the Novavax (NASDAQ: NVAX) NVX-CoV2373 vaccine was 51% effective against the B.1.351 variant in HIV-negative participants without evidence of prior SARS-CoV-2 infection. The overall vaccine efficacy against SARS-CoV-2 was 49% and 60% for HIV-negative participants, according to the study published in NEJM. The study authors note that the efficacy figures are…

Initial data from a Moderna (NSDQ:MRNA) Phase 2 trial found two versions of its COVID-19 vaccine increased neutralizing titers against SARS-CoV-2 and two variants in previously vaccinated clinical trial volunteers. A third dose of the company’s existing mRNA-1273 appears to improve immune response against the B.1.351 variant that first emerged in South Africa. But a booster dose…

As clinical trials have become more decentralized, there has been an increased focus on the need for more patient-centric drug development. This focus has led to a variety of eClinical applications. Electronic patient-reported outcomes (ePRO) and other electronic clinical outcome assessment (eCOA) approaches can transform trials to make them more pragmatic, patient-centric and efficient. Such…

After announcing that its vaccine was 100% efficacious in a Phase 3 trial involving adolescents aged 12 to 15, Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) are seeking authorization from the European Medicines Agency (EMA) to distribute the vaccine to that age group. BioNTech’s CEO, Uğur Şahin, estimated that the vaccine would be available to early adolescents in 27 European countries…

The Swiss pharma giant Roche (OTCMKTS:RHHBY) has canceled two Phase 2 COVID-19 studies while looking to identify a new site to conduct a clinical study for the oral antiviral AT-527, which it is developing with Atea Pharmaceuticals (NSDQ:AVIR.O). The two companies were looking to launch a trial in the U.K., but falling COVID-19 cases there have…

Regulatory authorities in the U.S. and Europe have either paused or constrained the use of COVID-19 vaccines from AstraZeneca (LON:AZN) and Johnson & Johnson (NYSE:JNJ), causing some to wonder why the adenoviral-vector vaccines have been potentially linked to similar blood clotting events. Researchers have observed blood clotting events associated with adenoviral vectors since the late-1990s…

An experimental oral antiviral from Pfizer that recently became the focus of a Phase 1 study was featured at the American Chemical Society Spring 2021 meeting. Known as PF-07321332, the compound is a protease inhibitor. It works by binding to a viral enzyme known as protease to block viral replication. Protease inhibitors are used to treat HIV/AIDS…