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In the lifesciences, countless Black scientists, researchers and medical professionals have made groundbreaking discoveries that have significantly advanced our understanding of biology and medicine.
The US Food and Drug Administration (FDA) has given emergency use authorization (EUA) to Novavax’s COVID-19 vaccine, making it the fourth authorized vaccine in the US against COVID-19. The vaccine is branded as Nuvaxovid outside the US with approvals/authorizations in Canada, the EU, UK, Australia and South Korea.
As Novavax awaits emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its protein-based COVID-19 vaccine NVX-CoV2373, the company shared new data this week on the vaccine’s efficacy against the South African B.1.351 That analysis also showed that the Novavax COVID-19 vaccine was 96.4
If the past year is anything to go by, then 2022 will also be a year marked by continued innovations in the lifesciences. Here is a look at some lifescience trends to expect in the coming year, including key themes and topics in the pharmaceutical, biotechnology and medical device industries to keep an eye out for in 2022.
Xtalks is taking a look at some of the major stories and innovations of the year in the lifesciences, many of which were driven by new, emerging and improved technologies. The year continued to be dominated by COVID-19, and the second year of the pandemic was all about vaccines. COVID-19: The Pandemic and the Vaccines.
In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology in Pharmaceuticals: Oncolytic viral proteins.
MBA, managing director at CanSino Biologics Europe, tells us about Convidecia, a single dose SARS-CoV-2 vaccine offered as an injectable and inhalant that allows ease of storage, an alternative option for individuals with needle phobias, and robust elongated CD4 and CD8 cellular response. Morgon, PharmD, LL.M,
This year will see the rolling out of much-awaited pandemic-ending COVID-19 vaccines. The pandemic is expected to continue well into 2021 amidst the delivery and distribution of COVID-19 vaccines worldwide. Lockdowns and closures will continue to have staged implementations as the vaccines are phased in.
Last week, a study that “stumbled upon” a vaccine for rheumatoid arthritis (RA) was published in the Proceedings of the National Academy of Sciences. The vaccine was tested in rats and showed strong, immediate and long-lasting immune responses to confer protection against the disease. With the finding that 14-3-3?
The EMA has kicked off a rolling review of a COVID-19 vaccine from Sanofi and GlaxoSmithKline, which started a 35,000-patient phase 3 trial in May. So far the EU has approved four COVID-19 vaccines – two mRNA shots from Pfizer/BioNTech and Moderna, and two based on adenoviral vectors from AstraZeneca and Johnson & Johnson.
Canadian pharma and biotech contract development and manufacturing organization (CDMO) Biovectra has announced plans for building one of the first state-of-the-art mRNA vaccine and biomanufacturing facilities in Canada. Related: Medicago’s Plant-Based COVID-19 Vaccine Enters Human Trials. million, respectively.
In this episode, Ayesha discussed the FDA authorization of Novavax’s COVID-19 vaccine, making it the fourth authorized/approved COVID vaccine in the US. It is also the first protein-based COVID-19 vaccine to be authorized in the country. Subscribe to the Xtalks LifeScience Podcast to never miss a new episode.
There have been growing reports of women experiencing changes in their menstrual cycle after receiving a shot of a COVID-19 vaccine. Some women have said they got their periods early following vaccination, or that their periods were unusually heavy and/or painful. Related: Moderna’s COVID-19 Vaccine Effective Against New Variants.
The World Health Organization (WHO) has backed Novavax’s COVID-19 vaccine, Covovax (NVX-CoV2373), by granting it an emergency use listing (EUL). The company is awaiting on authorization of its vaccine from regulatory health bodies around the world, including the US Food and Drug Administration (FDA) and Health Canada.
GlaxoSmithKline’s (GSK) Arexvy and Pfizer’s Abrysvo are the first-ever approved vaccines against respiratory syncytial virus (RSV). The vaccines received approvals from the US Food and Drug Administration (FDA) in May 2023 for the prevention of RSV infection. Arexvy costs $280 per dose while Abrysvo is $295.
Pfizer has announced that its respiratory syncytial virus (RSV) vaccine, Abrysvo, has received approval from the US Food and Drug Administration (FDA). Abrysvo, the bivalent RSV prefusion F (RSVpreF) vaccine, is intended for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 years and older.
Novavax shared the latest data from its ongoing late-stage COVID-19 vaccine trial, which shows that its yet-to-be authorized shot provides 100 percent protection against moderate and severe disease and has an overall efficacy of 90.4 Related: Latest Data from Novavax COVID-19 Vaccine Trial Involving B.1.351
After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease.
Adding to recent announcements from Pfizer and Moderna on the efficacy of their COVID-19 vaccine candidates, AstraZeneca and Oxford revealed today that their vaccine contender is 70 percent effective, and could be as high as 90 percent. Oxford-AstraZeneca COVID-19 Vaccine Induces Immune Responses in Early Clinical Trials.
The best way to prevent the flu is by getting vaccinated every year. The CDC and the World Health Organization (WHO) recommend annual flu vaccination for most people, especially those at high risk of serious complications, like pregnant women, elderly individuals, children and people with certain chronic health conditions.
Gelteq’s formulations enable the delivery of various active ingredients like branched-chain amino acids, protein, caffeine and essential minerals, opening applications in sports performance, nutrition and therapeutic use.
a pharmaceutical company of Johnson & Johnson, garnered emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its COVID-19 vaccine candidate (Ad26.COV2.S) S) over the weekend, shortly after evaluation of study data from trials of the vaccine by the agency. Janssen Inc.,
Dual-function fusion proteins represent a cutting-edge approach in biopharmaceutical research, offering a promising avenue for the development of novel therapeutics in the treatment of complex diseases such as cancer and autoimmune disorders. At the helm of this venture is Dr. Taylor H. How is your lead program differentiated?
Alexandre Le Vert, CEO and co-founder of Osivax, discusses the company’s breakthrough vaccine technology, oligoDOM, and how it’s driving the development of new influenza and SARS-CoV-2 vaccines that attack T-cells, providing a long-lasting effect. The technology. Antibodies cover the pathogen of the virus and neutralise it.
Moderna revealed the first interim results from a small, Phase I study of its mRNA-based influenza vaccine, which showed that the vaccine had no significant safety concerns and elicited immune responses against four strains of the influenza virus. Related: Moderna Unwilling to Share COVID-19 Vaccine Formula Amid Vaccine Inequities.
COVID-19 vaccine makers Pfizer/BioNTech and Moderna have both commenced trials for their new variant-specific vaccines targeting omicron. Pfizer and BioNTech have started to enroll participants in a study that will evaluate the new version of their COVID-19 vaccine that targets the omicron variant of SARS-CoV-2.
million state-of-the-art mRNA vaccine and biomanufacturing facility, making it one of the first in the country. The cutting-edge plant will be dedicated to the manufacturing of mRNA vaccines and therapeutics. Related: Biovectra to Build First mRNA Vaccine and Drug Manufacturing Plant in Canada. Learn more! In addition to a $39.8
Emergent BioSolutions, a multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland, has achieved a significant milestone with the approval of its Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted) vaccine by the US Food and Drug Administration (FDA). How Does Cyfendus Work? mL for intramuscular injection.
Within the emerging innovation stage, cell therapy for ocular disorders, coronavirus vaccine components, and DNA polymerase compositions are disruptive technologies that are in the early stages of application and should be tracked closely. There are four types of influenza viruses: A, B, C, and D.
Hereditary ATTR has an autosomal dominant pattern of inheritance and is caused by point mutations in the transthyretin ( TTR ) gene that codes for the transthyretin transport protein found in the plasma and cerebrospinal fluid. Alnylam filed lawsuits against both companies in March this year over the alleged patent infringements.
A vaccine developed by Swedish company Diamyd Medical has demonstrated significant treatment efficacy in a predefined genetic subgroup of individuals with type 1 diabetes in a Phase IIb clinical trial. In the trial, the vaccine was injected directly into the lymph nodes of type 1 diabetic individuals.
In this episode, Ayesha talked about the FDA approval of the world’s first vaccine for respiratory syncytial virus (RSV). The vaccine is approved for adults 60 years of age and older. Read more about the vaccine, including clinical trial results on its efficacy and safety.
Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. Related: Red Meat Allergy Test Gets FDA Clearance. “We
Within the emerging innovation stage, cell therapy for ocular disorders, coronavirus vaccine components, and DNA polymerase compositions are disruptive technologies that are in the early stages of application and should be tracked closely. These can serve as an important component of a vaccine.
As vaccinations continue to ramp up worldwide in the fight against COVID-19 amidst uncertainties over variants of concern, early data from a lab study shows that the mRNA COVID-19 vaccines from Pfizer and Moderna are effective against some of the variants. 1.117 and South African B.1.351 1.351 variants. 1.117 and South African B.1.351
Within the emerging innovation stage, cell therapy for ocular disorders, coronavirus vaccine components, and DNA polymerase compositions are disruptive technologies that are in the early stages of application and should be tracked closely. There are two main genes in the AAV genome, rep and cap, which encode nine different proteins.
Moderna has been testing an experimental mRNA vaccine aimed at combating the human cytomegalovirus (CMV), which poses significant health risks to newborns and immunocompromised patients. The team used the data and patient samples from a gB/MF59 Phase II trial in adolescent girls as a benchmark to assess the new mRNA-based vaccine.
The research provides an even more compelling reason to get vaccinated for those on the fence about the shot’s effectiveness at preventing the seasonal flu. These groups should have the highest vaccination rates because they are the most at risk; however, our findings show the opposite – flu vaccinations are under-utilized,” said Roshni A.
Vaccines are our number one weapon in the fight against infectious diseases, but their development has historically involved a long and complex process taking up to a decade. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed. mRNA’s potential for rapid vaccine delivery.
The company has signed on to help manufacture AstraZeneca’s COVID-19 vaccine candidate, AZD1222, intended to protect against the SARS-CoV-2 novel coronavirus. AMRI is proud to partner with AstraZeneca in pursuit of a vaccine that could protect people against the coronavirus pandemic,” said John Ratliff, CEO of AMRI, in a statement.
Last week, Novavax announced that it received positive feedback from the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) regarding the safety and efficacy of its COVID-9 vaccine (NVX-CoV2373). The Novavax COVID-19 Vaccine Candidate. The vaccine is given in two doses.
This study adds significant findings to Arexvy’s profile as the first RSV vaccine to show protection over such an extended period. The trial assessed vaccine efficacy using RSV-LRTD cases, which refer to lower respiratory tract infections caused by RSV, leading to complications like pneumonia. Efficacy over the entire study was 62.9
In addition, immunity against the infection is found to wane for both previously infected individuals and the vaccinated. Kai Kupferschmidt, a science journalist, shared an article on the rising measles cases worldwide. Measles is highly contagious and therefore is more visible when vaccine levels decline, the article noted.
Update (November 10, 2020): Pfizer and BioNTech announced in a press release yesterday that their candidate COVID-19 vaccine was found to be more than 90 percent effective in preventing infection by the novel coronavirus in Phase III trials. The ongoing Phase III trial continues to evaluate the mRNA vaccine in close to 44,000 individuals.
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