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There are no licensed vaccines for any human coronavirus.” Inactivated whole virus vaccines: 60 million doses Valneva. The government says if the Janssen and Novavax vaccine trials go well, the first deliveries could take place in mid-2021. mRNA vaccines: 30 million doses BioNTech/Pfizer.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The information contained in this release is as of May 7, 2021. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
The companies today reported findings on one secondary objective from the Phase 2a study, showing a reduction in time (days) to negativity of infectious virus isolation in nasopharyngeal swabs from participants with symptomatic SARS-CoV-2 infection, as determined by isolation in Vero cell line culture. About Molnupiravir.
This product was developed by uniQure prior to being licensed to CSL Behring. In June 2021, uniQure provided another regulatory update , announcing that FDA was requiring a demonstration of “durability of effect” based on data from patients followed for at least 52 weeks after FIX levels achieve steady state, which occurs by 26 weeks.
It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. Data on File Number: REF-131228, 10 November, 2021. Available at: [link] [Accessed August 2021] 6.
Still, with the continuing threat of the Delta variant and possible emergence of other variants in the future, we must remain vigilant against this highly contagious virus,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. We continuously strive to stay at least one step ahead of the virus. In the U.S.,
That’s how easy it’s for SARS-CoV-2, the virus that causes COVID-19, to enter your nose. As prior work with other respiratory pathogens like influenza has shown, sterilizing immunity to virus re-infection requires adaptive immune responses within the tract and therefore the lung. Breathe in, exhale. doi: 10.1016/j.isci.2021.103037.
05, 2021 (GLOBE NEWSWIRE) — ViGeneron GmbH , a gene therapy company, today announced a global collaboration and licensing agreement with Biogen Inc. USA) to develop and commercialize gene therapy products based on adeno-associated virus (AAV) vectors to treat inherited eye diseases.
MUNICH, Germany, Jan.
Expected to enroll 415 participants; interim results expected in Q3 2021. The Companies expect interim results from this trial in the third quarter of 2021. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio. About the Phase 1/2 clinical trial. About Translate Bio.
In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 About REGN-COV2 REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.
JUNE 22 , 2021. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. We look forward to evaluating the potential of these mRNA influenza vaccine candidates in this Phase 1 clinical trial.”.
04, 2021 (GLOBE NEWSWIRE) — Passage Bio , Inc. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for the company’s lead product candidate, PBGM01, an adeno-associated virus (AAV)-delivery gene therapy that is being studied for the treatment of infantile GM1 gangliosidosis (GM1).
In addition, Merck plans to initiate a clinical program to evaluate molnupiravir for post-exposure prophylaxis in the second half of 2021. Since licensed by Ridgeback, all funds used for the development of EIDD-2801/MK-4482 have been provided by Wayne and Wendy Holman and Merck. This press release features multimedia.
1, 2021 11:00 UTC. Our preclinical work at Gritstone developing our powerful prime-boost vaccine technology utilized simian immunodeficiency virus (SIV) derived antigens as model antigens, which are very similar to HIV-1. FOSTER CITY, Calif. & & EMERYVILLE, Calif.–( –( BUSINESS WIRE )– Gilead Sciences, Inc.
31, 2020 /PRNewswire/ — ImmVira Group Company (“the Company”), a biotechnology platform dedicated to the development of oncolytic virus(“OV”) and vector type approaches to create more effective and safer therapies against cancer, announced today the signing of Series C financing.
6, 2021– Moderna, Inc. The authorization is based upon the recommendation of the European Medicines Agency (EMA) for use of the COVID-19 Vaccine Moderna for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older. “I CAMBRIDGE, Mass.–(BUSINESS Authorized Use.
– Second Product Candidate Expected to Enter Clinic in First Half of 2021. 28, 2021 (GLOBE NEWSWIRE) — Passage Bio , Inc. Passage Bio expects to initiate a Phase1/2 clinical trial for PBFT02 in the first half of 2021. PHILADELPHIA, Jan. The FDA has granted an Orphan Drug designation for PBFT02 for the treatment of FTD-GRN.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The information contained in this release is as of May 6, 2021. This press release features multimedia. View the full release here: [link]. Pfizer Disclosure Notice.
iosBio , a UK-based biotechnology company, has announced an exclusive worldwide licensing agreement with ImmunityBio , a clinical-stage immunotherapy company, for rights to use iosBio’s OraPro vaccine platform technology to test the oral administration of ImmunityBio’s vaccine candidate.
Pfizer and BioNTech expect that Biovac’s Cape Town facility will be incorporated into the vaccine supply chain by the end of 2021. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The information contained in this release is as of July 21, 2021. Pfizer Disclosure Notice.
Government to supply doses in 2020 & 2021.
In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021.
immediately, with delivery fulfillment expected to be completed in 2021.
It is licensed for commercial use by Ecología y Protección Agricola (EPA) in Valencia and provides 400 days of pest control. The launch of Vynyty Citrus ® at this year’s SHE2021 event coincides with 2021 being designated as the International Year of Fruits and Vegetables by the United Nations.
About REGN-COV2 REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19. Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021.
Healthcare workers have been on the front lines of the fight against the virus and are an inspiration to us all. Moderna will continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021. Under Operation Warp Speed, the U.S. W911QY-20-C-0100.
Results from the PRECISION Study Expected in First Half of 2021.
The research is part of an ongoing collaboration between Columbia University and Tonix that focuses on T cell and antibody responses to SARS-CoV-2 (CoV-2), the virus that causes COVID-19.
CHATHAM, N.J., The research encompasses two projects.
27, 2021 (GLOBE NEWSWIRE) — BetterLife Pharma Inc. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. VANCOUVER, Jan. For further information please visit www.abetterlifepharma.com.
18, 2021 (GLOBE NEWSWIRE) — BetterLife Pharma Inc. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. VANCOUVER, Jan. For further information please visit www.abetterlifepharma.com.
12, 2021– Moderna, Inc. Posted: January 2021. CAMBRIDGE, Mass.–(BUSINESS –(BUSINESS WIRE)–Jan. About Moderna. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof. Source: Moderna, Inc. . MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History.
billion doses by the end of 2021. BNT162b2 encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is the target of virus neutralizing antibodies. billion doses by the end of 2021. billion doses by the end of 2021. About the Phase 2/3 Study.
About casirivimab and imdevimab Casirivimab and imdevimab (formerly known as REGN-COV2 or REGEN-COV2) is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.
OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. LONDON and BOSTON, Jan. LONDON and BOSTON, Jan.
This is a meaningful moment for adolescents, parents and entire families who are seeking protection from this virus and a return to normalcy,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Participants received two 30 ?g
Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021. Department of Health and Human Services under OT number: HHSO100201700020C. If REGN-COV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S.
The FDA has set an action date of July 7, 2021. These proinflammatory T cells promoted bacterial clearance after infection with Staphylococcus aureus and, by licensing encephalitogenic Th17 cells, played a key role in the development of autoimmune disease in the central nervous system,” the authors stated. Patient Recruitment.
(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced preliminary preclinical data in mouse and non-human primate models from their BNT162b2 mRNA-based vaccine program against SARS-CoV-2, the virus that causes COVID-19 disease. billion doses by the end of 2021. About Pfizer: Breakthroughs That Change Patients’ Lives.
We are also focused on minimizing potential interactions that could contribute to the spread of the virus and put additional strain on healthcare systems through the use of innovative virtual means where possible. Alexion plans to initiate a Phase 3 study of SOLIRIS in GBS in Japan in 2021, pending regulatory feedback.
billion doses by the end of 2021. We are proud to share our findings with the scientific community as we continue our work to deliver a safe and effective vaccine to combat this devastating virus,” said Kathrin U. billion doses by the end of 2021. NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc.
These windows depend on whether the new drug application (NDA) or biologics license application (BLA) is a new molecular entity, and if the application has received standard review (10 months, plus 2 months of administrative time) or priority review (6 months, plus 2 months of administrative time).
We are also expanding our odronextamab program with multiple pivotal trials in 2021.” We are currently enrolling patients in a potentially registrational Phase 2 portion of this REGN5458 trial.
. “The recent results from our NAVIGATOR trial were impressive, both in terms of the overall clinical data and the reduction in exacerbation rate with tezepelumab treatment, and we continue to work with AstraZeneca on planned regulatory filings in 2021.
doi: 10.2210/rcsb_pdb/goodsell-gallery-048 The Virus that Cures It’s been over 25 years since the science magazine Discover first ran an extraordinary article about how a long-forgotten medical treatment, used in the former Soviet country of Georgia, could save us from the growing threat of untreatable, drug-resistant infections.
12, 2021 /PRNewswire/ — . Under the new agreement, the government will purchase all finished doses of the casirivimab and imdevimab antibody cocktail delivered by June 30, 2021 , up to 1.25 “Additionally, as expected, the virus continues to mutate, with the possibility of developing resistance to any one antibody. .
21, 2021 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. “While much more remains to be done to make HIV history, today’s milestone reminds us how far medical innovation has come since the first reported cases of the virus almost 40 years ago.” In the U.S.,
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