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Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K. GAITHERSBURG, Md.,
We pointed out last week that China was a notable missing element in AstraZeneca’s COVID-19 vaccine strategy, despite being the drugmaker’s second-largest market. The pair will also explore the possibility of producing the vaccine for other markets. The vaccine was moved into phase 2/3 in May. That has changed.
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Sanofi and GSK have begun a Phase I/II clinical trial testing their adjuvanted COVID-19 vaccine in healthy adults. The vaccine candidate, developed in partnership by the firms, is based on the recombinant protein-based technology used in Sanofi’s seasonal influenza vaccines and GSK’s pandemic adjuvant technology.
company developing UB-612 a multitope peptide-based vaccine to fight COVID-19, today announced an exclusive agreement with Aurobindo Pharma to expand its global development and commercialization of UB-612 to India and the United Nations Children’s Fund (UNICEF) agency. Commenting on the development, Mr. N.
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.
In the unprecedented context of at least 13 variants circulating within the study population subset assessed at this interim analysis, CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. About CVnCoV. About CureVac.
The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. No serious adverse events related to the vaccine candidates studied were reported.
Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial.
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.
24, 2020 /PRNewswire/ —
COVAXX’s UB-612 is the first multitope, synthetic peptide-based COVID-19 vaccine candidate in clinical trials and it utilizes normal refrigeration (no freezing required) for distribution.
COVAXX is currently conducting a Phase 1 clinical trial for the vaccine candidate. .
(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. President of Research and Development, Novavax.
We appreciate the confidence of the Ministry of Health of Qatar in our mRNA vaccine platform and the collaboration we have had to date,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co.,
FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. Government to supply doses in 2020 & 2021.
Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021.
immediately.
(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.
Under the MoU, the companies and the IOC will coordinate with National Olympic Committees (NOCs) around the world to understand and work to help address the local need for vaccine doses for national delegations’ participation in the Games. We are proud to play a role in providing vaccines to athletes and national Olympic delegations.”.
The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S.
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.–(
billion doses by the end of 2021; the companies will be ready to distribute the vaccine within hours after authorization.
BNT162b2 demonstrated a vaccine efficacy rate of 95%, with no serious safety concerns observed to date.
by the middle to end of December 2020. participants are 56-85 years of age.
The vaccine supply for the EU would be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium. billion doses by the end of 2021. billion doses by the end of 2021. CEO and Co-founder of BioNTech.
times the GMT of a panel of 38 sera of SARS-CoV-2 convalescent patients, and in older adults (65-85 years of age) the vaccine candidate elicited a neutralizing GMT 1.6 billion doses by the end of 2021. study of the BNT162 mRNA-based vaccine program against SARS-CoV-2, which has advanced into Phase 2/3 evaluation. Jansen, Ph.D.,
The BNT162b2 vaccination also cleared the nose of detectable viral RNA in 100% of the SARS-CoV-2 challenged rhesus macaques within 3 days after the infection. Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc. Jansen, Ph.D.,
COVID-19 have caused delays to submission and processing of the regulatory application to initiate clinicaldevelopment in China.
Due to the unforeseen delays, Targovax has extended the term of IOvaxis’s license option by 3 months, otherwise the agreement remains unchanged.
OSLO, Norway , Jan.
(Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today confirmed that the Ministry of Health, Labour and Welfare of Japan (MHLW) and Takeda Pharmaceutical Co.,
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].
Study May Lead to Biomarkers for Tailoring COVID-19 Vaccines and Therapeutics.
Potential Development of Human Monoclonal Antibody Therapeutics to SARS-CoV-2.
Results from the PRECISION Study Expected in First Half of 2021.
CHATHAM, N.J., About TNX-1800. 1 Noyce RS, et al. 2018) PLoS One.
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.
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
.
Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose.
Jansen, Ph.D.,
(Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis.
These data were shared as a late-breaking oral presentation during the virtual 11 th International AIDS Society Conference on HIV Science (IAS 2021) and are a follow-up to the interim analysis that was presented earlier this year at the virtual 2021 HIV Research for Prevention Conference (HIVR4P 2021). About Merck.
About the author Daniel Kavanagh, PhD, RAC Senior Scientific Advisor, Gene Therapies, Vaccines and Biologics at WCG Dr Kavanagh engages with sponsors, CROs and research institutions on topics related to human gene transfer research. The FEBS Journal 288:6159–6173 (2021). References Robinson R, McMurran C, McCully M, Cole D.
20, 2021 /PRNewswire/ — INOVIO Pharmaceuticals, Inc. The offering is expected to close on or about January 25, 2021 , subject to customary closing conditions. PLYMOUTH MEETING, Pa. , Gross proceeds to INOVIO from the offering are expected to be approximately $150.5 All of the shares are being sold by INOVIO.
We are delighted to share our early data at CROI 2021 supporting the potential for a once-yearly dosing regimen for islatravir using a subdermal implant,” said Dr. Joan Butterton, vice president, global clinicaldevelopment, infectious diseases, Merck Research Laboratories. “We Our Commitment to Infectious Diseases.
Gilead Lores, and Merck, known as MSD outside the United States and Canada, moment blazoned the launch of a Phase 2 clinical study assessing an investigational formerly-daily oral combination treatment authority of islatravir and lenacapavir in people living with HIV who are virologically suppressed on antiretroviral remedy. About Merck.
HALIX – Based in The Netherlands, HALIX BV and AstraZeneca forged an agreement to support large-scale commercial drug substance manufacture of AZD1222, the adenovirus vector-based COVID-19 vaccine. The investment will be used to enable Spirea’s ADC therapeutic programs ahead of a significant Seed financing anticipated in 2021.
Emile Voest is currently director of Cancer Core Europe, a collaboration of 7 top comprehensive cancer centers in Europe and was Executive Medical Director of the Netherlands Cancer Institute (NKI) until 2021. Antoine Yver took over in 2021 as Chief Medical Officer of Centessa Pharmaceuticals, Inc.
More mature clinical and immunobiological data are expected to be announced by the end of the second quarter of 2021. Additional MPM patients are currently being enrolled; completion of study enrollment (target total n = 10) and more mature clinical and immunobiological data are expected by the end of the second quarter of 2021.
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.
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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. A further announcement will be made in due course.
The guidance concludes with a brief section on “process considerations” that strongly emphasizes the importance of rationalizing the chosen approach to establishing efficacy with high specificity early in the clinicaldevelopment process. When should this occur? at the end-of-phase 2 meeting).
The CHMP positive opinion and recommended indication reflect the robust data from avalglucosidase alfa’s clinicaldevelopment program. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. Avalglucosidase alfa has been granted Promising Innovative Medicine designation in the U.K.
Recent and significant activities among these top CROs based in the US include the acquisition of Pharmaceutical Product Development (PPD), a global industry leader in clinicaldevelopment and analytical services, by Thermo Fisher Scientific Inc. launched a PV platform for clinical research registries.
The appointment of a Chair is expected in the second half of 2021 who will then, in accordance with best practice, lead the process of appointments to establish the new Board. As announced at the Investor Update, New GSK will disclose revenues of Vaccines and Specialty Medicines.
25, 2021 /PRNewswire/ — Therapeutic Solutions International, Inc., (OTC Given that we have already treated patients with StemVacs, and we have filed an Investigational New Drug (IND) application for this product, we are excited in its development prospects.”
OCEANSIDE, Calif.,
ir@tsoimail.com.
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