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
30, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. 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. Additional clinical data from the Phase 2 trial conducted in the U.S. GAITHERSBURG, Md.,
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. This press release features multimedia. View the full release here: [link].
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.
09, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. 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.
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.
4, 2020 08:00 UTC. 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.
Valneva SE (“Valneva”), a specialty vaccine company focused on prevention of diseases with major unmet needs, and Pfizer Inc. As announced in December 2020 1 , VLA15-221 is a randomized, observer-blind, placebo-controlled Phase 2 study. We are excited to be part of the Lyme disease vaccinedevelopment program with Valneva.
Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, today announced the start of the Phase 1/2 clinical trial for MRT5500, an mRNA vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.
The global COVID-19 pandemic increased awareness of the importance of vaccinedevelopment — both for drug developers and the public. The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developedvaccines, there was variation among who could receive the shots and when.
22, 2020 07:13 UTC. The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020. “We About UV1
UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase.
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, and Pfizer Inc. Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA15 2.
26, 2020 11:00 UTC. 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.,
11, 2020 02:48 UTC. –( BUSINESS WIRE )– ImmunityBio , a privately-held immunotherapy company, today announced its COVID-19 vaccine candidate protected nasal and lung airways of non-human primates against coronavirus (SARS-CoV-2) in a challenge study. CULVER CITY, Calif.–(
.
Based on current projections, the companies expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021; the companies will be ready to distribute the vaccine within hours after authorization.
by the middle to end of December 2020. participants are 56-85 years of age.
The proposed agreement is intended to provide a supply of 200 million doses and an option to purchase additional 100 million doses, with deliveries starting by the end of 2020, subject to regulatory approval. Deliveries would be starting by the end of 2020, subject to clinical success and regulatory authorization.
Friday, December 11, 2020.
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.
Centers for Disease Control and Prevention (CDC), will manage allocation and distribution of the vaccine in the U.S.
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 study of the BNT162 mRNA-based vaccine program against SARS-CoV-2, which has advanced into Phase 2/3 evaluation. billion doses by the end of 2021.
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.,
27, 2020 10:45 UTC. –( BUSINESS WIRE )– Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2020.
2020.
for the third quarter of 2020. .
for the third quarter of 2020. KENILWORTH, N.J.–(
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. Curing HIV remains the ultimate aspiration for Gilead’s HIV research and development efforts.
The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. under an Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. We are pleased to work with U.S. AUTHORIZED USE IN THE U.S.:
Thursday, December 10, 2020 – .
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.
20, 2020 10:45 UTC. –( 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. KENILWORTH, N.J.–(
(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.
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.
30, 2020– Moderna, Inc. The data analysis indicates a vaccine efficacy of 94.1%. The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. CAMBRIDGE, Mass.–(BUSINESS –(BUSINESS WIRE)–Nov.
2, 2020 07:05 UTC. 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.
29, 2020 06:00 UTC. 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., CAMBRIDGE, Mass.–(
NEW YORK & MAINZ, GERMANY–(BUSINESS WIRE) November 9, 2020.
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.
Pfizer Inc. Today is a great day for science and humanity.
Study May Lead to Biomarkers for Tailoring COVID-19 Vaccines and Therapeutics.
Potential Development of Human Monoclonal Antibody Therapeutics to SARS-CoV-2.
15, 2020 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp.
Results from the PRECISION Study Expected in First Half of 2021.
BioNTech SE (NASDAQ: BNTX, “BioNTech” or “the Company”), announced that the first patient has been treated in its BNT111 Phase 2 cancer vaccine trial (2020-002195-12; NCT04526899). We were able to demonstrate the potential of mRNA vaccines in addressing COVID-19. About FixVac. About BioNTech.
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.
30, 2020 (GLOBE NEWSWIRE) — HOOKIPA Pharma Inc. .
30, 2020 (GLOBE NEWSWIRE) — HOOKIPA Pharma Inc.
24, 2020 07:05 UTC. OSLO, Norway–( BUSINESS WIRE )– Ultimovacs ASA (“Ultimovacs”, ticker ULTIMO), today announced that Ton Berkien will join Ultimovacs’ management team as Chief Business Officer (CBO), effective December 1, 2020. Mr. Berkien is a Dutch and Swedish citizen and is based in Sweden.
30, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today new data for baricitinib (marketed as OLUMIANT ® ) will be presented at the annual Fall Clinical Dermatology meeting taking place virtually October 29-November 1, 2020. vice president of immunology development at Lilly.
FDA ACCEPTS FOR PRIORITY REVIEW PFIZER’S APPLICATION FOR TICOVAC (TICK-BORNE ENCEPHALITIS VACCINE). If approved, the vaccine may help reduce the risk of TBE for people traveling to endemic areas, potentially including military personnel serving in these locations. 1,2 If approved, TicoVac would be the first vaccine in the U.S.
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. As with any vaccine, vaccination with COMIRNATY® may not protect all vaccine recipients.
In October 2020, based on a positive evaluation of safety and tolerability data of VIR-7831 from the lead-in part of the trial by an Independent Data Monitoring Committee, the trial began enrolling patients in North America and additional sites in South America and Europe in the global Phase 3 portion of the trial.
They are currently working with Boehringer Ingelheim to further identify and develop these antibodies. They are expected to enter clinicaldevelopment later this year. This may indicate that SARS-CoV-2 antibodies are easily formed and that live vaccines may provide rapid protection.
The CHMP positive opinion and recommended indication reflect the robust data from avalglucosidase alfa’s clinicaldevelopment program. The CHMP positive opinion for avalglucosidase alfa follows the EMA’s acceptance of Sanofi’s MAA at the end of 2020. About Sanofi.
12 November 2020 — The CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. Accessed October 2020.
Accessed October 2020.
Posted: November 2020. NCT identifier: NCT04380688. Available online.
On December 15, 2020 , the U.S. “The funding will enable us to execute on our breakthrough therapy designation grant and advance our lead programs in late-stage clinicaldevelopment, as we are committed to bringing our treatment to patients as soon as possible.” Priyanka Belawat of HBM Partners, Jack B.
Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. New stability, immunogenicity, and tolerability data for COVID-19 vaccine candidate, BNT162b2, presented. BNT162 mRNA-based Vaccine Program.
Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.
Evusheld has the potential to provide long-lasting protection against COVID-19 for a broad population of individuals, including those who aren’t adequately protected by a COVID-19 vaccine, as well as those at increased risk of exposure.”. 1-3 Evusheld was generally well-tolerated in the trial.
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