This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
Novartis announced today that it has signed an initial agreement to manufacture the mRNA and bulk drug product for the COVID-19 vaccine candidate CVnCoV from CureVac to aid in the fight against the COVID-19 pandemic. Preparations for the start of production, technology transfer and test runs are already underway.
As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. The combined analysis showed average efficacy of 70%.
In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S. Ugur Sahin, M.D.,
• Submission based on real-world safety and efficacy data from Israel • Data showed rates of confirmed infections were 2 times lower and rates of severe illness were 4 times lower among individuals who received an additional booster dose of Pfizer-BioNTech COVID-19 Vaccine compared to individuals who received only an initial booster.
These results will be presented by the lead investigators of OBI Pharma’s novel anti-Globo H therapeutic cancer vaccine, OBI-833. Department of Internal Medicine, Tri-Service General Hospital, Taipei, Taiwan. Department of Hematology and Oncology, Taipei Medical University Hospital, Taipei, Taiwan.
Professor Binder and her team are well-recognized experts who will increase our understanding of UV1’s mechanism of action and contribute data on anti-tumor activity induced by UV1 vaccination.”. About UV1
UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase.
has been appointed Senior Vice President and Head of the Company’s Vaccine Research & Development (R&D) organization effective August 1, succeeding Kathrin U. Anderson most recently served as Vice President and Chief Scientific Officer for Bacterial Research and Hospital within the Vaccine R&D organization.
.–( BUSINESS WIRE )– Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced findings from two additional Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine. among adults 65 years of age or older.
has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. The distribution of the vaccine in the U.K. View the full release here: [link].
Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis.
This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.
”
Dr. Stanley Plotkin , Professor Emeritus at The Wistar Institute, said, “INOVIO’s DNA vaccine appeared to be quite safe with few significant reactions but yet induced both antibody and T cell responses to SARS-CoV-2.” .
PLYMOUTH MEETING, Pa. ,
The participants were enrolled into 1.0
One of the oldest and most successful immunotherapies is simpler: a tamed version of a classic vaccine, against the infectious disease tuberculosis (TB). “BCG” is the “treatment” vaccine’s technical name, for Mycobacterium bovis Bacillus Calmette-Guérin. And every so often, tumors shrank.
The FDA decision is informed by the results of the Phase 2b proof-of-concept study of RSVpreF (NCT04032093), a global, double-blinded, placebo-controlled study that assessed the safety and immunogenicity of RSVpreF in healthy pregnant women ages 18 through 49 years old, who were vaccinated between 28- and 36-weeks gestation, and their infants.
(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), underscoring the observed substantial public health impact of Israel’s nationwide immunization program.
Pfizer-BioNTech files for US approval of COVID-19 vaccine ( Reuters ) ( NYTimes ) ( Politico ) ( Press ).
Covid-19 Vaccines Are Wasted as Special Syringes Run Short ( WSJ ).
The US opened pandora’s box on IP waivers for Covid-19 vaccines. .
In Focus: US.
What happens now?
This is the focus of vaccines in development and convalescent plasma therapy. The majority of current candidate vaccines aim to induce an antibody response against the spike protein. The majority of current candidate vaccines aim to induce an antibody response against the spike protein. “As
NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19 , has received Emergency Use Authorization (EUA) from the U.S. TARRYTOWN, N.Y., November 21, 2020 – Regeneron Pharmaceuticals, Inc.
patients hospitalized with COVID-19. We are pleased vaccines are now approved for the prevention of COVID-19; however, a significant unmet need remains for effective treatments for symptomatic patients.
Patient Population: 45 hospitalized patients with COVID-19. LONDON and RALEIGH, N.C., David Zaccardelli, Pharm.
As one among the leading global vaccines companies, we still bring options which help protect people’s health round the world,” said Michael Greenberg, MD, MPH, Medical Head, Sanofi Pasteur North America. “We A study conducted from 2014 to 2015 showed 72% of infants hospitalized for RSV were previously healthy with no underlying conditions.3.
Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization. “Tackling the COVID-19 pandemic will require a combination of public health measures, vaccines and therapeutics.
First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, 1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. Senior Vice President and Head of Vaccine Research & Development, Pfizer.
Early interim data show Cytomegalovirus (CMV)-negative kidney transplant recipients vaccinated with three doses of HB-101 had reduced incidence of CMV viremia, reduced antiviral use and no CMV disease.
Antiviral therapies are used to help control disease, but they are limited by toxicity and the emergence of viral resistance.
In the future, when doctors give patients cytokine therapies targeting the immune system, they could potentially look in the Immune Dictionary for expected cell-level immune responses. What makes this study significant? Did any results surprise you? You could then block those cytokines in animal models and see what their roles are.
This week Pharma IQ looks at how the pharma industry is expanding its vaccine manufacturing and testing protocols to ensure the deadly Covid-19 outbreak yields in its spread around the globe. . BioNTech acquires Novartis GMP manufacturing site to expand Covid-19 vaccine production.
6, 2021 — Cases of anaphylactic shock caused by COVID-19 vaccines are very rare, based on numbers from the first week and a half of vaccinations in the United States, federal public health officials said Wednesday. Seven out of 10 cases occurred within 15 minutes of vaccination. WEDNESDAY, Jan.
Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2).
Current vaccines and medicines work by intervening against these life phases. After successful testing on animals, Tu and her colleagues volunteered to test the drug sample on themselves, spending a week in a Beijing hospital to do so. Multiple species of Plasmodium infect humans, but P.
QDENGA is the only dengue vaccine approved in Brazil for use in individuals regardless of previous exposure to dengue and without the need for pre-vaccination testing. QDENGA is the only dengue vaccine approved in Brazil for use in individuals regardless of previous exposure to dengue and without the need for pre-vaccination testing.
government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. Bamlanivimab and etesevimab together and bamlanivimab alone are not authorized for use in patients: who are hospitalized due to COVID-19, OR. who require oxygen therapy due to COVID-19, OR. Limitations of Authorized Use.
NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (also known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19, has received Emergency Use Authorization (EUA) from the U.S. Regeneron Pharmaceuticals, Inc. Food and Drug Administration (FDA).
Our flagship HIV therapy, Biktarvy, saw continued growth and gains in market share, despite the ongoing impact of the pandemic,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “The Cell Therapy product sales increased 39% to $219 million for the second quarter 2021 compared to the same period in 2020.
Core institute members have a major research presence at Broad, and remain full members of their home institution (MIT, Harvard University, or one of Harvard’s primary teaching hospitals). She is a professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, and a member of the Broad’s Executive Leadership Team.
What trends are driving the increased use of in vivo delivery methods in gene therapy? Generally, the amount of lentiviral vector that is used for in vivo gene therapy is larger than for ex vivo use. How are new therapeutic areas emerging as potential targets for in vivo gene therapy?
” — Harold Morowitz 🔥 Ten Amazing Things (that happened this week…) A CAR-T therapy was tested in 27 children with neuroblastomas. Read Efficacy and safety of a bivalent RSV prefusion F vaccine in older adults. Molecular Therapy. Gene Therapy. npj Vaccines. Support for $5 per month.
government to meet Operation Warp Speed goals – are fundamental to enable the most widespread and equitable access to our potential therapy,” said David A. The supply of Lilly’s antibody therapy is expected to increase substantially beginning in Q1 2021, as additional manufacturing resources come online throughout the year.
In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. Hahn , M.D.
11,12 Existing therapies to treat post-transplant CMV infections may demonstrate toxicities that require dose adjustments or may fail to adequately suppress viral replication. 11–13 Additionally, existing therapies may require or prolong hospitalization due to administration. About maribavir.
Stem cell transplants have saved patients’ lives time and time again, which led us to launch our own Stem Cell Transplant and Cellular Therapy Program. Regarding CAR-T cell therapy, could you highlight the promising findings that have been identified in the early stages of drug discovery, as well as potential challenges?
I suffered from anxiety and depression, was not taking good care of myself, and my body got weaker… I kept getting sick and ended up in hospital a few times with sky-high fever. Then, 9 years ago, I went through a difficult divorce. Then I found a very good therapist who helped me a lot emotionally. Alisha Smith. Liverpool, UK.
In most cancers, the tumour evolves by acquiring mutations that confer growth advantages or resistance to therapies. Involving more than 250 investigators based at 19 hospital sites across the UK, the study has analysed genetic signatures in lung tumours, tracking how they have evolved over the past nine years in more than 815 patients.
Food and Drug Administration (FDA) is plenty busy with COVID-19 vaccine Emergency Use Authorizations (EUAs) this month, but they’re also wrapping up the year with a few PDUFA dates for other therapies. Here’s a look. Urovant Sciences’ Vibegron for Overactive Bladder.
Cannot be combined with special category rates, clinic/hospital rates, non-profit rates or other offers. Channel Strategy for First Medical Product – A Look at Channel Considerations for Pharmacy vs. Informa Connect - CBI will see you there! Cannot be combined with other offers or used towards a current registration.
Gunther Hartmann from the Institute of Clinical Chemistry and Clinical Pharmacology at the University Hospital Bonn, in cooperation with other members of the cluster of excellence ImmunoSensation2 at the University of Bonn, have shown this in mice. Molecular Therapy – Nucleic Acids, 2022. doi: 10.1016/j.omtn.2022.02.008.
The clinical study was completed in collaboration with scientific teams at the Harvard Medical School (Boston, USA), Santa Casa de Misericórdia de Santos Hospital (Santos, Brazil) and INTRIALS, a world-class, full-service Latin American CRO based in São Paulo, Brazil. .
NEW YORK and LONDON, Jan.
We organize all of the trending information in your field so you don't have to. Join 15,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content