FDA, Industry, Regulations, Vaccines
January 30, 2023
Via: Biopharm InternationalA more harmonized formula and schedule for administering COVID-19 vaccines gained strong support from FDA’s expert advisory panel last week, with agreement on the need to reduce confusion over which shot to take and when in order to increase vaccination […]
FDA, Industry, Regulations, Vaccines
January 27, 2023
Via: Kaiser Health NewsAt a meeting to simplify the nation’s covid vaccination policy, the FDA’s panel of experts could agree on only one thing: Information is woefully lacking about how often different groups of Americans need to be vaccinated. That data gap has […]
January 18, 2023
Via: Kaiser Health NewsA new coronavirus variant is circulating, the most transmissible one yet. Hospitalizations of infected patients are rising. And older adults represent nearly 90% of U.S. deaths from covid-19 in recent months, the largest portion since the start of the pandemic. […]
January 11, 2023
Via: Drugs.comWhile COVID-19 vaccine acceptance rose around the world between 2021 and 2022, wide gaps remain, according to new research. Teams from the Barcelona Institute for Global Health in Spain (ISGlobal) and City University of New York (CUNY) also noted the […]
January 9, 2023
Via: PMLiVEThe tested vaccine candidates produced promising immunogenicity and reactogenicity profiles in ongoing phase 1 clinical programmes for COVID-19 and seasonal flu, assessing both modified and unmodified mRNA technology. “The positive results from this preliminary data analysis strongly validate the power […]
Clinical Trials, Research and Development
January 4, 2023
Via: PMLiVEThe start of the trial triggers a $5m milestone payment from AZ, which licensed AZD3152 from RQ Bio in May last year, and reinforces the financial position of the UK-based biotech to execute its four scientific programmes focused on viral […]
FDA, Industry, Regulations, Vaccines
December 9, 2022
Via: PMLiVEThe Pfizer/ BioNTech vaccine is now indicated for children aged six months to four years who have not yet received the third dose of the three-dose primary series with the monovalent Pfizer/BioNTech COVID-19 vaccine. Meanwhile, Moderna’s bivalent vaccine is now […]
December 7, 2022
Via: PMLiVEIn its decision, the ETF reviewed non-clinical studies and data on the immune response following natural infection with Omicron BA.4/BA.5 in unvaccinated people who had not been previously infected with SARS-CoV-2. The data suggested that primary vaccination with adapted bivalent […]
Clinical Trials, Research and Development
November 28, 2022
Via: Drugs.comWhen pregnant women contract COVID-19, one in 10 will have moderate, severe or even critical symptoms, a new study finds. So it’s important they get their COVID vaccines, experts say. “Given that patients in all trimesters of pregnancy are susceptible […]
Clinical Trials, Industry, Research and Development, Vaccines
November 14, 2022
Via: PMLiVEShipments of the Beta-targeting booster are ready to be distributed to European countries as per advance purchase agreements, the companies said in a statement, in time for autumn/winter COVID-19 vaccination campaigns. “Today’s approval validates our research in developing a novel […]
September 20, 2022
Via: PharmaphorumVaccines have transitioned from being a largely unloved area of the industry, with multiple big pharma companies divesting their vaccine divisions, to the biggest revenue drivers seen in recent years. This all comes down to the impact of the pandemic. […]
September 19, 2022
Via: GENThe World Health Organization (WHO) Guideline Development Group recommended that patients with COVID-19 not receive the antibody drugs sotrovimab and casirivimab-imdevimab. The Group’s recommendation replaces previous conditional recommendations “Rapid Recommendations: A living WHO guideline on drugs for Covid-19,” published in […]
Clinical Trials, Research and Development
September 9, 2022
Via: PharmaphorumThe pandemic forced clinical trial sponsors to change their processes, with a more technology-driven approach and, according to a new study by Medidata, the sector is now “stronger than ever” as a result. The study, based on interviews conducted earlier […]
September 8, 2022
Via: Drugs.comWhile vitamin D got some attention early in the pandemic, it does not reduce the risk of either COVID-19 or other respiratory infections, two new clinical trials found. Both studies, one done in the United Kingdom and the other in […]
September 7, 2022
Via: Drugs.comWhile researchers explore the possibilities of COVID-19 vaccines that don’t require an injection, public health officials in India and China have already each approved new needle-free versions for their citizens. In India, regulators on Tuesday approved a nasal vaccine developed […]
September 7, 2022
Via: Drugs.comCOVID-19 vaccines will likely go the way of flu shots in the future, with updated doses given annually, U.S. health officials said Tuesday. “In the absence of a dramatically different variant, we likely are moving towards a path with a […]
September 6, 2022
Via: PharmaphorumThe NHS is moving to the next phase of its SARS-CoV-2 vaccination programme, following health secretary Steve Barclay’s acceptance of advice from the Joint Committee on Vaccination and Immunisation (JCVI) to go ahead with rollout of Pfizer’s bivalent 30mg booster […]
September 1, 2022
Via: PharmaphorumCyrus Massoumi, founder of Dr. B, tells us about his online platform that makes physician assessment readily available to patients and provides access to COVID-19 therapeutics that may otherwise be difficult to obtain. COVID-19 antiviral medications Paxlovid (nirmatrelvir/ritonavir) and Lagevrio […]
August 31, 2022
Via: Contract PharmaPfizer Inc. and BioNTech SE was granted Emergency Use Authorization (EUA) by the U.S. FDA for a 30-µg booster dose of the Pfizer-BioNTech COVID-19 vaccine, bivalent (Original [15 µg] and Omicron BA.4/BA.5 [15 µg]) for individuals ages 12 years and […]
August 31, 2022
Via: PharmaphorumThe US regulator has cleared a 30 µg booster dose of a new version of Pfizer’s Comirnaty shot – 15 µg encoding the spike protein of the original wild-type SARS-CoV-2 strain and 15-µg of mRNA coding for Omicron BA.4/BA.5 – […]