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announced today that the companies have entered into a definitive agreement under which Pfizer will acquire ReViral, a privately held, clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel antiviral therapeutics that target respiratory syncytial virus (RSV).
Interim data in this event-driven trial are expected as soon as early first quarter 2021, although the timing depends on the overall COVID-19 rate in the region. availability of efficacy data depends on the illness rate in South Africa and may be available as soon as the first quarter 2021. European Union and other countries.
econd Quarter 2021 Product Sales Increased 21% Year-Over-Year Primarily Driven by Veklury. Nasdaq: GILD) announced today its results of operations for the second quarter 2021. “We Second Quarter 2021 Financial Results. Total second quarter 2021 revenue of $6.2 As of June 30, 2021, Gilead had $7.4
In the first half of 2021, Boehringer Ingelheim has supplied more humans and animals worldwide with innovative medicines than ever before. Our strong R&D pipeline has made further, decisive progress in the first half of 2021. In the first half of 2021, Boehringer Ingelheim generated strong net sales of around 2.3
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.
Each T cell expresses a TCR specific for an HLA‑presented peptide signal, and when that signal is detected a T cell expressing the relevant TCR can launch a complex array of immune effector responses that can suppress or destroy tumours or virus-infected cells. The FEBS Journal 288:6159–6173 (2021).
19, 2021 06:30 UTC. BT-001 IS AN ONCOLYTIC VIRUS GENERATED WITH TRANSGENE’S INNOVATIVE INVIR.IO oncolytic virus (VVcopTK-RR-), and has been engineered to encode both a Treg-depleting human recombinant anti-CTLA4 antibody generated by BioInvent’s proprietary n-CoDeR®/F.I.R.S.T BT-001 is based on the patented Invir.IO
Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.
These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinicaldevelopment.”
In line with Priority Review designation, the FDA will target an action within six months of the application submission date, 3 with the anticipated Prescription Drug User Fee Act (PDUFA) action date expected for August 2021. 5 To date, ticks infected with the TBE virus have been identified in more than 35 countries across Europe and Asia.
Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinicaldevelopment for both adjuvanted vaccines. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
The outcome confirms that only one single case was attributable to the original SARS-CoV-2 virus. “In addition, the variant-rich environment underlines the importance of developing next-generation vaccines as new virus variants continue to emerge.” CureVac remains committed to COVID-19 vaccine development.
Preclinical data suggest VIR-7831 targets a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop. About the VIR-7831 ClinicalDevelopment Programme. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells.
In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 Senior Vice President and Head of Global ClinicalDevelopment at Regeneron. Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021. There was a 1.08
– Second Product Candidate Expected to Enter Clinic in First Half of 2021. 28, 2021 (GLOBE NEWSWIRE) — Passage Bio , Inc. Nasdaq: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system (CNS) disorders, today announced that the U.S.
In addition, Merck plans to initiate a clinical program to evaluate molnupiravir for post-exposure prophylaxis in the second half of 2021. This press release features multimedia. View the full release here: [link]. “It About Molnupiravir.
Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. 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. About Translate Bio.
(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Currently in late-phase clinicaldevelopment, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant.
GMP Production of TNX-1500 is Expected to be Available in the Third Quarter of 2021. 14, 2021 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals, Inc. WO 2021/001458 A1. Lederman added, “We believe the development risk of TNX-1500 is mitigated by previous clinical data and extensive preclinical science with ruplizumab.
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ASLAN appoints neurologist Professor Gavin Giovannoni as a scientific advisorto establish clinicaldevelopment strategy in multiple sclerosis.
The company expects to share further details in early 2021.
SINGAPORE, Oct. In 2019, ASLAN completed a Phase 2 study testing ASLAN003 in AML.
04, 2021 (GLOBE NEWSWIRE) — TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, announced today that its subsidiary, InspirMed Inc., SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Jan.
All doses expected to be delivered in 2021. NEW YORK and MAINZ, GERMANY, April 19, 2021 (GLOBE NEWSWIRE) — Pfizer Inc. NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they will supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states in 2021.
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.
Potential Development of Human Monoclonal Antibody Therapeutics to SARS-CoV-2.
Results from the PRECISION Study Expected in First Half of 2021.
Tonix is also developing TNX-2300* and TNX-2600*, live replicating vaccine candidates for the prevention of COVID-19, but using bovine parainfluenza as the vector.
25, 2021 /PRNewswire/ — Elasmogen Ltd , the pioneering biopharmaceutical company leading the development of VNAR and soloMER biologics, today announces a significant breakthrough in the identification of next-generation protein-based drugs potentially capable of stopping COVID-19 infections. ABERDEEN, Scotland , Jan.
In March 2021, an Independent Data Monitoring Committee recommended that the COMET-ICE trial be stopped for enrolment due to evidence of efficacy and is continuing to follow study participants for 24 weeks. About the Sotrovimab ClinicalDevelopment Program. About the Vir and GSK Collaboration.
Senior Vice President and Head of Global ClinicalDevelopment at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinicaldevelopment program.” and Roche will develop, manufacture and distribute it outside of the U.S.
For most of 2021, limited global vaccine supply led to huge disparities in COVID-19 vaccine access, leaving billions of people – especially in low- and middle-income countries – unprotected against serious disease and death from COVID-19.
1, 2021 11:00 UTC. Gilead and Gritstone will develop an HIV-specific therapeutic vaccine using Gritstone’s proprietary prime-boost vaccine platform, comprised of self-amplifying mRNA (SAM) and adenoviral vectors, with antigens developed by Gilead. FOSTER CITY, Calif. & & EMERYVILLE, Calif.–(
In 2021, the FDA issued draft guidance on Credibility of Computational Modeling & Simulation (CM&S) in Medical Device Submissions. Our goal at Premier Research is to help customers leverage these innovative technologies and accelerate rare disease clinicaldevelopment with high quality and reduced cost.
These results, however, were not statistically significant and, as such, the primary endpoint of reducing the risk of confirmed and symptomatic COVID-19 infection in adults who had been exposed to the virus through a household contact was not met. Additional details on the study are available on clinicaltrials.gov (NCT05047601).
The extensive Actemra/RoActemra RA IV clinicaldevelopment programme included five phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. As soon as the novel SARS-CoV-2 virus was sequenced in early 2020, we got to work. On 13 March 2020 we became the first company to receive U.S.
TSX: CRDL ) ( OTCQX: CRTPF ) is a clinical-stage biotechnology company focused on the research and clinicaldevelopment of anti-inflammatory therapies for the treatment of cardiovascular disease (CVD). Oakville, Ontario–(Newsfile Corp. Cardiol Therapeutics Inc. (
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The scientific approaches underlying this clinical study could potentially be effective against SARs, MERS, and all variants of coronaviruses.
The topline data from the trial is expected to be available in January 2021.
NEW YORK and LONDON, Jan.
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.
since December 2021 under Emergency Use Authorization (EUA), and the overall benefit/risk profile and indication for use in eligible adults remain consistent with the EUA. 1) “Great advancements have been made in the fight against COVID-19, yet the virus remains a present and unpredictable concern. .” More than 11.6
To facilitate Biovac’s involvement in the process, technical transfer, on-site development and equipment installation activities will begin immediately. Pfizer and BioNTech expect that Biovac’s Cape Town facility will be incorporated into the vaccine supply chain by the end of 2021. Pfizer Disclosure Notice.
Senior Vice President and Head of Global ClinicalDevelopment at Regeneron. The company expects to complete the manufacture of these doses on schedule in January 2021 and is in discussions with the U.S. and Roche will develop, manufacture and distribute it outside the U.S. Under an agreement with the U.S. In the U.S.
It involves taking a patient’s own white blood cells, called T-cells, and modifying them so they can identify and target HIV cells to control the virus without medication. The trial is the first-in-human clinical study investigating the duoCAR T-cell therapy for the treatment of HIV. The novel study uses immunotherapy.
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.
The award honors McHutchison’s work in developing life-changing and curative therapies for patients with the hepatitis C virus. The committee is tasked with supporting BeyondSpring’s business development activities related to its lead asset, Plinabulin, and other pipeline assets. BeyondSpring – BeyondSpring Inc.
The information contained in this release is as of May 6, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This press release features multimedia. View the full release here: [link]. Pfizer Disclosure Notice.
The information contained in this release is as of May 7, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. 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.
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