Janssen (NYSE:JNJ) is working to highlight the importance of cancers such as leukemias, lymphomas and multiple myeloma for Blood Cancer Awareness Month in September. Some 1.5 million people in the U.S. are currently living with or in remission from blood cancers, according to the Leukemia & Lymphoma Society. Roughly 35,000 people are diagnosed with multiple myeloma…

FDA has published draft guidance to clarify its perspective on including children in clinical trials. The agency notes that it wrote the draft guidance to help industry, sponsors and institutional review boards (IRBs) protect children in clinical studies testing drugs, biological products and medical devices. The draft guidance is titled “Ethical Considerations for Clinical Investigations of Medical…

It’s easy to feel like clinical trials are complex. They are experiments involving human beings — so things change. But, despite feeling like complexity is everywhere, there is little clarity on what constitutes a complex trial and what sponsors need to do to prepare these trials for success. Both the FDA and EMA, for example,…

As a growing number of emerging biopharma companies seek to develop novel treatments for chronic diseases, the clinical trials market could be worth $78.3 billion by 2030.  Clinical trials, however, continue to be difficult and expensive to manage. Yet successful clinical trials, however, remain critical for investors. Small biopharmas are thus looking for guidance in navigating…

Blockchain may be arguably one of the most hyped technologies in recent memory, but the distributed ledger technology better known for its role in cryptocurrency may have significant potential in the pharma supply chain, clinical trials and beyond. A blockchain-based initiative known as PharmaLedger has won support from prominent companies like Pfizer, Novartis, Merck &…

The lack of appropriate representation in clinical trials, particularly in terms of ethnicity and race, has been a long-standing issue that directly impacts health equity and treatment efficacy. In a 2020 analysis of the global participation in clinical trials, the Food and Drug Administration (FDA) highlighted the vast difference between enrolled participants and the global population.…

Lack of diversity in clinical trials has long been an issue, driven by challenges with recruitment and participation. In recent years, pharmaceutical companies have prioritized recruiting more diverse patient groups for their trials. And in some areas, it is working. In the past ten years, the representation of Black and African American patients in U.S.-based…

The task of extracting health insights from electronic health records (EHRs) has taken longer to materialize than some pundits projected a decade or so ago. But the situation is quickly changing with continued advances in data science, said Sujay Jadhav, CEO of Verana Health (San Francisco), which has created a real-world data network in partnership…

Radiomics, or the science of advanced imaging analytics, is an emerging field that promises more personalized care, improved clinical decision support and greater efficiency in clinical trials.  Radiomics are being used to discover new biomarkers, improve the accuracy of diagnosis, predict the risk of disease and likelihood of treatment response, and identify clinical endpoints. Today,…

The pharma industry has been slower to embrace technologies such as AI and digital technology than many less-regulated sectors. The COVID-19 pandemic has changed the equation, forcing pharma companies to become more agile and open-minded in approaching drug discovery and development, including managing evolving clinical trials. In this article, several experts offered their predictions of…

RedHill Biopharma Ltd. (NSDQ:RDHL) has randomized the last patient in Part A of an ongoing Phase 2/3 study focused on RHB-107 (upamostat), an investigational antiviral. The Tel Aviv–based company anticipates that RHB-107, a serine protease inhibitor, would be broadly effective against emerging SARS-CoV-2 variants. RedHill Biopharma expects top-line data for Part A of the trial,…

Merck (NYSE:MRK) and Ridgeback Biotherapeutics appear to be gaining growing support for their oral COVID-19 therapy molnupiravir. One week after Great Britain granted conditional marketing authorization for the drug, the companies announced that the U.S. government intends to purchase 1.4 million additional medicine courses for approximately $1 billion. The U.S. has committed to buy approximately 3.1…

Pharmaceutical regulations in Japan are continuously expanding and updating to improve the safety of pharmaceutical drugs. Throughout history, the detection and understanding of harmful side effects of pharmaceutical drugs have led to new enhancements of regulations to allow regulatory agencies to find adverse events more effectively. In turn, this has led to stricter regulations. Likewise,…

Merck’s (NYSE:MRK) investigational oral COVID-19 drug could net between $5 billion and $7 billion in revenue through the end of 2022 if FDA authorizes its use in December, the company projected. Sales of the drug could be higher, assuming it finds widespread use in wealthy countries. Merck expects sales between $500 million and $1 billion…

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have announced that their COVID-19 vaccine was 90.7% effective at protecting against symptomatic COVID-19 in children ages 5 to 11.  The study concluded that a 10-µg dose of the BNT162b2 vaccine, which is one-third the amount authorized for people 12 and older, had the best benefit-risk profile. Recipients…

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…