covid-19

The Global Institute of Stem Cell Therapy and Research (GIOSTAR) has announced that the FDA has authorized emergency use of its stem cell therapy for hospitalized COVID-19 patients. The San Diego–based organization has offered stem cell therapy for COVID-19-related symptoms since April 2020. The compassionate use authorization will enable GIOSTAR to offer stem cell therapy…

CDC today released comparative effectiveness data for the three COVID-19 vaccines available in the U.S. in individuals without immunocompromising conditions. The study also found that protection from the Pfizer-BioNTech vaccine dipped four months after vaccination to 77%. The effectiveness of the Moderna vaccine at that interval was 92%. The CDC also concluded that, from March 11…

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously supported emergency use authorization to administer the Pfizer-BioNTech Comirnaty vaccine as a booster to those 65 years of age and older, and individuals at high risk of developing severe COVID-19. The panel, however, resoundingly rejected a plan to administer the vaccine as a booster to…

FDA has expanded the emergency use authorization for Lilly’s (NYSE:LLY) bamlanivimab and etesevimab combo to include post-exposure prophylaxis. Earlier in the year, federal authorities had counseled against the use of the  monoclonal antibody cocktail in several states given the rise of SARS-CoV-2 variants in the U.S., including Gamma (P.1) and Beta (B.1.351). Meanwhile, demand for…

Minorities tend to participate in clinical trials at far lower rates than their real-world demographics and prevalence of the disease, according to the American Society of Clinical Oncology. In addition, minorities often have worse outcomes for certain cancers than the broader public. Just one example: the mortality rate for Black women with breast cancer is 40% higher than…

Facing the second-biggest wave of COVID-19 infections and waning popularity, President Biden has promised to launch an initiative to begin providing vaccine boosters starting September 20.  But the plan hinges upon FDA and CDC support, and some officials at the agencies remain unconvinced that boosters are immediately necessary.  Two departing senior FDA vaccine officials recently co-wrote…

This September is Pulmonary Fibrosis Awareness Month, which the Pulmonary Fibrosis Foundation (PFF) and allies have launched to educate the public about the disease family. Involving scarring of the lungs, pulmonary fibrosis gradually robs the breath from patients it affects.  Some 250,000 Americans live with idiopathic pulmonary fibrosis, according to PFF.   At present, two drugs…

FDA leaders have issued a statement regarding the agency’s plan for authorizing COVID-19 vaccines for children. The FDA plans to “follow the science” with eyes on COVID-19 vaccines for children younger than 12 as schools begin to get back in session around the country, the agency said in a news release attributed to acting Commissioner…

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…

FDA determined it couldn’t conclude that the benefits of lenzilumab from Humanigen (NSDQ:HGEN) outweigh the risks for patients hospitalized with COVID-19.  Lenzilumab is the company’s lead product candidate.  The drug works by neutralizing granulocyte-macrophage colony-stimulating factor (GM-CSF), which is implicated in the so-called cytokine storm.  The drug is the subject of 16 clinical trials spanning…

While President Biden initially announced that COVID-19 boosters would be available by September 20, media reports suggested that the announcement caught FDA off guard. White House chief medical advisor Dr. Anthony Fauci recently suggested in an interview with CBS’s “Face the Nation” that the U.S. government is scaling back its booster plan for the broader…

The FDA notified Kaleido Biosciences (NSDQ:KLDO) determined that the Lexington, Massachusetts-based company did not submit investigational new drug (IND) applications for clinical trials related to the investigational drug KB109, a microbiome modulator. The two clinical trials in question, dubbed “Protocol K031-120” and “Protocol K032-120,” are testing KB109 in adults with mild-to-moderate COVID-19. KB109 is a synthetic…

AstraZeneca (LON:AZN) and the European Union have agreed to end litigation related to the supply of its COVID-19 vaccine Vaxzevria (ChAdOx1-S). AstraZeneca had initially contracted with the European Commission to provide 300 million doses of its vaccine with an option for another 100 million, but fell short of its commitment. The level of vaccine doses,…

The FDA has scheduled a virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss Pfizer’s supplemental application for a COVID-19 vaccine booster.  While President Biden has embraced the concept of boosters as early as five months post-second dose, other experts within the government have recommended a more cautious approach. In addition, WHO has…

Moderna (NSDQ:MRNA) announced that it initiated its submission to the FDA for a booster dose of its COVID-19 vaccine. Cambridge, Massachusetts–based Moderna expects to submit data to the European Medicines Agency and other regulatory authorities around the world in addition to the FDA in the coming days for the booster shot at a 50 µg…

COVID-19 vaccines could potentially guard against dementia and Alzheimer’s disease, according to an op-ed in WSJ.  COVID-19 infection itself can lead to long-term cognitive decline in some individuals and can accelerate Alzheimer’s symptoms, concluded an Alzheimer’s Association study. An Alzheimer’s Research & Therapy echoed those findings.  Pointing to data suggesting that vaccinations against tetanus and flu lead to reduced…

Research published in JAMA found the Moderna’s COVID-19 vaccine drove an antibody response that was more than two times greater than that of Pfizer’s. Specifically, the Moderna mRNA-1273 vaccine generated post-second-dose antibody levels of 2,881 units per milliliter. Those who received the Pfizer-BioNTech BNT162b2 vaccine had antibody levels measuring 1,108 units per milliliter. The study involved 1,647…

Two senior vaccine leaders within the FDA are reportedly relinquishing their positions within the administration. According to a report from Endpoints News citing a letter released internally to FDA staff first reported on by BioCentury, Marion Gruber and Phil Krause will depart in the coming months due to frustrations over the delegation of certain decisions within…

Israeli researchers report that an additional dose of Pfizer (NYSE:PFE) and BioNTech’s (NISDQ:BNTX) COVID-19 vaccine leads to notable improvements in immunity in people 60 and older. The protection against infection increased fourfold 10 days after administration of the third dose, according to scientists at the Gertner Institute (Ramat Gan, Israel) and KI Institute (Kfar Malal, Israel).…

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…

A handful of companies may have a lock on COVID-19 vaccines, but competition is heating up in antivirals targeting the novel coronavirus. One of the latest entrants is Pardes Biosciences (Carlsbad, Calif.), which recently announced a Phase 1 trial for PBI-0451, an oral antiviral targeting SARS-CoV-2. Other companies developing antivirals for COVID-19 include Pfizer as well as…

Signal Rx Pharmaceuticals, Crystec and ADYA are working on a dry powder drug formulation for potentially treating COVID-19-related illness. The three companies’ collaboration for the dry powder formulation of SF2523 covers the treatment of pulmonary fibrosis, lung cancer and illnesses related to SARS-CoV-2, the virus causing COVID-19. Get the full story at our sister site,…

Pfizer (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) aim to expand the recent FDA approval of their COVID-19 vaccine to include booster doses for individuals 16 and older. The companies have submitted a supplemental Biologics License Application to the FDA, including Phase 3 data drawn from participants aged 15 to 55. The latest data indicate…

Johnson & Johnson (NYSE:JNJ) has announced that a booster of its viral-vector COVID-19 vaccine led to considerable increases in coronavirus spike-binding antibodies, according to interim data from two Phase 1/2 trials known as VAC31518COV1001 and VAC31518COV2001. In particular, the boosters led to a nine-fold increase in antibodies relative to levels 28 days after administering the prime…

The investigational antibody ​​AZD7442 from AstraZeneca (LON:AZN) fared well in the PROVENT study, reading the risk of developing symptomatic COVID-19 by 77% compared to placebo. More than three-quarters of participants in the trial had comorbidities that could potentially reduce their immune response to vaccination. “We need additional approaches for individuals who are not adequately protected by COVID-19…