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 – […]
August 26, 2022
Via: PharmaphorumModerna has filed complaints in the US and Germany claiming that the mRNA technology used to make Pfizer and BioNTech’s Comirnaty vaccine infringes multiple patents that cover its own Spikevax shot. Among the claims is that Comirnaty was developed using […]
August 17, 2022
Via: Drugs.comThe Biden Administration plans to stop buying COVID tests, vaccines and treatments as early as the fall, White House COVID-19 Response Coordinator Dr. Ashish Jha said Tuesday. Under that plan, those products would be provided through the regular health care […]
August 17, 2022
Via: PMLiVEFor adults aged 18 years and above, the JCVI’s advised vaccines include Moderna’s mRNA (Spikevax) bivalent Omicron BA.1/original wild-type vaccine, as well as its mRNA (Spikevax) original wild-type vaccine. The Pfizer/BioNTech mRNA (Comirnaty) original wild-type vaccine is also advised, and […]
July 28, 2022
Via: World Pharma NewsNew research shows that a needle-free mucosal bacteriophage (phage) T4-based COVID-19 vaccine is effective against SARS-CoV-2 infection. The findings were published in mBio, an open access journal of the American Society for Microbiology. In recent years, the Food and Drug […]
July 28, 2022
Via: Kaiser Health NewsWhen President Joe Biden tested positive for covid-19 on July 21, his physician recommended he take the antiviral drug Paxlovid. The drug significantly reduces the likelihood of hospitalization or death for someone at high risk of developing severe covid. Biden […]
July 22, 2022
Via: Natalie DunnWhile the COVID-19 pandemic wreaked havoc and forced scientists and policymakers to create or search for vaccines and treatments, common disorders continued to affect millions of human lives. The pandemic made it harder for people suffering from chronic conditions to […]