Alnylam Pharmaceuticals has proprietary lipid nanoparticle technology used in its FDA-approved RNA therapies. The biotech company claims that the messenger RNA Covid-19 vaccines from Moderna and Pfizer infringe on a patent covering this LNP technology.
The new Covid-19 variant, named Omicron, has mutations that could help it evade antibodies produced by the immune system. Scientists are conducting lab tests to better understand this new variant and pharmaceutical companies are testing how existing vaccines, as well as those in development, measure up the new mutations.
At the Payer Insights sessions on Day 1 of ViVE 2024, a panel on prior authorization offered compelling insights from speakers who shared the positive developments in this area after years of mounting frustration. Speakers also shared challenges as they work with providers to figure out how policy developments and technology will work in practice.
The FDA amended emergency use authorization of the Moderna and Johnson & Johnson Covid-19 vaccines, permitting booster shots. But the agency went further and said that a booster shot may be different than the one given for the primary vaccination.
The short answer is that cancer vaccines represent no silver bullet but can prove potent in combination with other immunotherapy and drug cocktails.
Moderna released preliminary clinical data showing its Covid-19 vaccine produced efficacy in adolescents that was comparable to what was seen in adults. The company plans to submit applications to regulators in early June seeking expansion of emergency authorization of the vaccine to include this younger age group.
The FDA increased the maximum number of doses permitted for each vial of Moderna’s Covid-19 vaccine, a change intended to make more doses available. The regulator also authorized storage changes for the vaccines at vaccination sites.
The TSX Venture Exchange has a strong history of helping early-stage health and life sciences companies raise patient capital for research and development.
The CEOs of Pfizer, Moderna, McKesson and CVS Health explained that the distribution effort has gone well but the administration of the vaccine has now to catch up. They expect it to happen soon.
Moderna's leadership team dodged questions about their assessment of the largely slow and dysfunctional vaccine rollout focusing instead of telling the story of the science behind a decade-old biopharma company whose first commercial product is making history.
The rollout of two newly authorized Covid-19 vaccines is a bright ray of hope at the pandemic’s darkest hour. Both are expected to be available to the public in the first few months of next year. Here are answers to some questions you might be asking yourself about the new vaccines.
Moderna is using a Roche antibody test in clinical trials of its Covid-19 vaccine. The test can measure the antibodies created through vaccination, offering a window into how long protection lasts.
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
As Covid-19 vaccine doses make their way around the country, there has been a lack of guidance and miscommunication at the federal level, leaving state officials to make key decisions on distribution amid a chaotic mass vaccination effort.
The company's vaccine is the second approved for emergency use by the FDA. It is expected to pose fewer logistical challenges than the first, which was developed by Pfizer and BioNTech.
By creating new networks for 24/7 temperature monitoring, alerts and reporting, the challenges of deploying transportation at ultra-low temperatures can be overcome. This also illustrates the crucial role that precision measurement will have to play.
Covid-19’s impact on children represents a tiny fraction of the suffering and death experienced by vulnerable adults. Yet it's pretty serious having caused 154 deaths and more than 7,500 hospitalizations as of Dec. 3 among people 19 and younger in the United States.
The nonbinding recommendation is a final hurdle before an official emergency use authorization for the vaccine, which could be the first shot approved for use in the U.S. Distribution, however, will remain a challenge.