FDA, Industry, Regulations, Vaccines
January 23, 2023
Via: Biopharma DiveThe Food and Drug Administration is considering shifting to an annual process for updating COVID-19 vaccines to match circulating coronavirus strains, akin to the current approach for influenza. The proposal from agency staff, released Monday ahead of a Thursday meeting […]
March 30, 2022
Via: Drugs.comCOVID-19 vaccines appear to be safe for kids who have had a rare complication called MIS-C after being infected by the coronavirus, according to a new small study. Some kids get MIS-C — shorthand for multisystem inflammatory syndrome in children […]
Clinical Trials, Research and Development
January 3, 2022
Via: Biopharma DiveOne year ago, the biotechnology sector was in the middle of a record run. The successful development of coronavirus vaccines and drugs had helped slow the pandemic and propelled investment into new companies going public at a historic rate. Biotech […]
October 28, 2021
Via: Medical NewsResearchers in the United States have conducted a large-scale study showing that the two-dose regimen vaccines developed by Pfizer-BioNTech and Moderna to protect against coronavirus disease 2019 (COVID-19) appear to be highly effective and durable in reducing the risk of […]
October 25, 2021
Via: FierceBiotechMerck has opened another front in its campaign to get molnupiravir to market, kicking off a process that could lead to the approval of the oral COVID-19 antiviral in the EU. Things have moved quickly since Merck and partner Ridgeback […]
October 5, 2021
Via: FierceBiotechAstraZeneca has taken another step toward bringing its COVID-19 antibody cocktail to market, filing for emergency use authorization of the long-acting candidate in coronavirus prophylaxis in the U.S. Last month, AstraZeneca delivered evidence that the candidate prevents COVID-19 in people […]
September 29, 2021
Via: Genetic Engineering and Biotechnology NewsSanofi said it is pivoting its messenger RNA vaccine (mRNA) program—acquired over the summer when it bought Translate Bio for $3.2 billion—away from COVID-19 and toward influenza and other pathogens, despite announcing positive Phase I/II data for the vaccine candidate […]
September 21, 2021
Via: Biopharma DiveA second dose of Johnson and Johnson’s coronavirus vaccine appears to increase protection from moderate to severe COVID-19, the company said Tuesday after months of questions on how well the efficacy of its single-shot regimen would hold up over time. […]
August 30, 2021
Via: Genetic Engineering and Biotechnology NewsAn estimated 8% of Americans have an autoimmune disease, including a disproportionate number of people in the minority communities most severely impacted by COVID-19. In addition, higher rates of severe COVID-19 and death have been reported in people with autoimmune […]
August 30, 2021
Via: Medical NewsScientists and pharmaceutical companies have successfully generated vaccines to fight the coronavirus disease (COVID-19) pandemic. Most of these vaccines are very effective in combating the disease. However, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an RNA virus that has […]
August 26, 2021
Via: Genetic Engineering and Biotechnology NewsNew research from Japan shows hamsters inoculated with spike gene mutants that lack the protease cleavage site are resistant to subsequent infection with both the parent strain and emerging alpha (UK/B.1.1.7) and gamma (Brazil/P.1) SARS-CoV-2 variants. “SARS-CoV-2 spike gene mutants […]
July 26, 2021
Via: Medical NewsThe development and emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants of concern that could potentially evade a vaccine-induced immune response is an ongoing concern, with the alpha (B.1.1.7), beta (B.1.351), gamma (B.1.248), and delta (B.1.614.2) lineages having […]
July 12, 2021
Via: Medical NewsWith the coronavirus disease 2019 (COVID-19) pandemic causing unprecedented morbidity and mortality, the development of an effective antiviral drug for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has become a global health priority. Although many drug candidates have been identified […]
July 9, 2021
Via: Medical NewsA recent study by a team of scientists at Beth Israel Deaconess Medical Center and Janssen Vaccines & Prevention has demonstrated that humoral and cellular immunity elicited by the coronavirus disease 2019 (COVID-19) vaccine Ad26.COV2.S remains active for at least […]
July 1, 2021
Via: Medical NewsIn a U.S. and Swiss study, nearly all patients with cancer developed good immune response to the COVID-19 mRNA vaccines three to four weeks after receiving their second dose, but the fact that a small group of the patients exhibited […]
June 17, 2021
Via: Medical NewsA new study looking at the way human cells activate the immune system in response to SARS-CoV-2 infection could open the door to even more effective and powerful vaccines against the coronavirus and its rapidly emerging variants keeping the global […]
January 18, 2021
Via: CNBCThe head of the World Health Organization said Monday the equitable distribution of coronavirus vaccines is at “serious risk.” Warning of a “catastrophic moral failure,” WHO’s Director-General Tedros Adhanom Ghebreyesus said “the recent emergence of rapidly-spreading variants makes the rapid […]
November 19, 2020
Via: Biopharma DiveHospitals across the country are ramping up their efforts to figure out how to store, track and administer coronavirus vaccine doses as confidence grows that an effective vaccine could soon become available. Hospitals will play a key role once a […]
November 11, 2020
Via: Pharma TimesBamlanivimab is now available under emergency use for the treatment of mild to moderate COVID-19 in adults and paediatric patients 12 years and older who are at high risk of progressing to severe COVID-19 and/or hospitalisation. In a statement, Lilly […]
November 9, 2020
Via: CNBCNumerous pharmaceutical companies are racing to complete clinical trials and become the first to successfully get U.S. approval for a vaccine to fight the coronavirus, which has infected more than 50.5 million people worldwide in 11 months. A safe and […]