The Pharma Data

OCTOBER 15, 2020

UK-based contract research organization Open Orphan said it is in advanced negotiations with the British government and other partners for a human challenge trial of a COVID-19 vaccine.

Vaccine 52

Vaccine Trials Government Production 52

The Pharma Data

NOVEMBER 11, 2020

Moderna has released promising early results from a small phase 1 trial of its experimental personalized cancer vaccine, mRNA-4157, in combination with Merck’s Keytruda (pembrolizumab). The study enrolled 10 patients with human papillomavirus- (HPV) negative head and neck cancer and 17 colorectal cancer patients. drugmaker said.

Vaccine 52

Vaccine Trials Research 52

The Pharma Data

OCTOBER 22, 2020

Moderna has completed enrollment of 30,000 participants for its phase 3 study evaluating COVID-19 vaccine candidate mRNA-1273. The randomized, placebo-controlled trial is being conducted in partnership with the NIH’s National Institute of Allergy and Infectious Diseases and HHS’ Biomedical Advanced Research and Development Authority.

Vaccine 52

Vaccine Trials Disease Research 52

The Pharma Data

NOVEMBER 16, 2020

Inovio announced that it has begun the phase 2 segment of a phase2/3 clinical trial to evaluate INO-4800, its potential coronavirus vaccine funded by the Department of Defense. The phase 2 study, which will enroll 400 participants at 17 U.S.

Vaccine 52

Vaccine Trials Clinical Trials Research 52

The Pharma Data

NOVEMBER 29, 2020

AstraZeneca’s COVID-19 vaccine candidate is facing another potential delay as the company plans to undertake a new global clinical trial to confirm the vaccine’s 90 percent efficacy based on a one-and-a-half-dose regimen. An additional trial could further delay AZ’s efforts to earn an EUA in the U.S., James Miessler.

Vaccine 52

Vaccine Trials FDA Clinical Trials 52

The Pharma Data

DECEMBER 8, 2020

8, 2020 — AstraZeneca’s COVID-19 vaccine is safe and effective, new data from late-stage trials shows. Overall, the vaccine protected against symptomatic disease in 70% of cases, according to a team led by researchers from Oxford University in England. TUESDAY, Dec. 8 in The Lancet.

Vaccine 52

Vaccine Trials Immune Response RNA 52

The Pharma Data

NOVEMBER 18, 2020

18, 2020 — Children should be included in clinical trials for a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine at the earliest stages, according to a letter from the president of the American Academy of Pediatrics (AAP), on behalf of more than 67,000 pediatricians and pediatric medical and surgical subspecialists.

Vaccine 52

Vaccine Trials Immune Response Virus 52

The Pharma Data

DECEMBER 22, 2020

CanSino Biologics has enrolled more than 20,000 participants in a global phase 3 study of its COVID-19 vaccine candidate, Ad5-nCoV, co-developed with a research arm of the Chinese military. The trial is being conducted in Argentina, Pakistan, Russia, Mexico and Chile. Source link.

Vaccine 52

Vaccine Trials Pharmacy Research 52

The Pharma Data

NOVEMBER 3, 2020

The Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to fund development of a potential COVID-19 vaccine from China’s Clover Biopharmaceuticals with a global phase 2/3 study and through licensing and distribution. million for an initial trial of SCB-2019 in Australia that enrolled 150 participants.

Vaccine 52

Vaccine Trials Licensing Licensing 52

The Pharma Data

NOVEMBER 30, 2020

Novavax said it will begin a delayed phase 3 trial in the U.S. and Mexico to evaluate its COVID-19 vaccine candidate, NVX-CoV2373, “in the coming weeks” and that its 15,000-person late-stage trial in the UK is now fully enrolled. The new study aims to enroll up to 30,000 participants. Source link.

Vaccine 52

Vaccine Trials Research 52

The Pharma Data

DECEMBER 9, 2020

The University of Oxford has attempted to clarify the dosing error it and AstraZeneca (AZ) made in a clinical trial assessing COVID-19 vaccine AZD1222, following divergent reports between the two of what exactly transpired. Chief among them, can the vaccine fight asymptomatic infections? percent ( DID , Dec. Jason Scott.

Vaccine 52

Vaccine Trials Clinical Trials Regulations 52

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. 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. JUNE 22 , 2021.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov.

Clinical Trials 52

Clinical Trials Vaccine Trials FDA Approval 52

The Pharma Data

DECEMBER 20, 2020

Oxford University released new trial data last week that raises further questions about the most effective dosing regimen for Oxford’s COVID-19 vaccine candidate, AZD1222, that is being co-developed with AstraZeneca and how it came to pass that two different dosing regimens were pursued. AstraZeneca is leading the phase 3 U.S.

Vaccine 52

Vaccine Trials Regulations FDA 52

The Pharma Data

DECEMBER 10, 2020

Moderna has started dosing adolescent participants in a phase 2/3 trial evaluating vaccine candidate mRNA-1273, planning to enroll 3,000 U.S. volunteers aged 12 to 17.

Vaccine 52

Vaccine Trials Research 52

The Pharma Data

NOVEMBER 10, 2020

Russia’s Gamaleya Center Research Institute claimed its investigational COVID-19 vaccine, Sputnik V, has demonstrated 92 percent efficacy in a late-stage trial. The finding was based on interim data from a phase 3 study, based on 20 confirmed cases of COVID-19, split across patients given the vaccine and patients given the placebo.

Vaccine 52

Vaccine Government Trials Research 52

The Pharma Data

SEPTEMBER 12, 2020

Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.

Vaccine 52

Vaccine Trials Clinical Trials Small Molecule 52

The Pharma Data

SEPTEMBER 22, 2020

Clinical trials testing Russia’s Sputnik-V coronavirus vaccine in India could begin in the next few weeks, according to Indian pharma firm Dr Reddy’s Laboratories Ltd. . The trials are part of a deal by Dr Reddy’s and the Russian Direct Investment Fund (RDIF). Photo by NIAID. Dr Reddy’s signed a deal with the RDIF last week.

Clinical Trials 52

Clinical Trials Vaccine Trials Laboratories 52

The Pharma Data

DECEMBER 11, 2020

The Australian government has scrapped a supply deal with CSL for 51 million doses of its COVID-19 vaccine co-developed with the University of Queensland, after trial participants falsely tested positive for HIV. Source link.

Vaccine 52

Vaccine Immune Response Trials Government 52

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. “Our About the Phase 1/2 clinical trial.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

JULY 21, 2021

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. If successful, this trial could enable the inclusion of a pediatric population in the Phase 3 trial.

Vaccine 52

Vaccine Disease Trials Protein Expression 52

The Pharma Data

OCTOBER 25, 2020

German drugmaker CureVac said preclinical studies of its COVID-19 vaccine candidate, CVnCoV, showed the vaccination prompted a successful immune response. The messenger RNA-based vaccine, which is designed to block replication of the coronavirus, was shown to induce neutralizing antibodies and activate T-cells in hamsters and mice.

Vaccine 52

Vaccine Immune Response RNA Clinical Trials 52

The Pharma Data

SEPTEMBER 17, 2020

The illness of one of the participants in the Oxford-AstraZeneca COVID-19 vaccine trial may not have been caused by the treatment itself, according to newly revealed information. . The trials testing the vaccine have resumed in Britain, Brazil and South Africa after they were initially paused on 6 September.

Vaccine 52

Vaccine Trials Virus Treatment 52

The Pharma Data

DECEMBER 7, 2020

China’s Clover Biopharmaceuticals has announced its COVID-19 S Trimer vaccine candidate delivered a “strong immune response” in 150 adult and elderly phase 1 trial participants, with pre-publication results to be released soon. based Dynavax Technologies to boost the vaccine’s efficacy. Jason Scott. Source link.

Vaccine 52

Vaccine Immune Response Clinical Trials Trials 52

The Pharma Data

JUNE 25, 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.

Vaccine 52

Vaccine Trials Immune Response Virus 52

The Pharma Data

NOVEMBER 18, 2020

19, 2020 /PRNewswire/ — OBI Pharma, Inc. These results will be presented by the lead investigators of OBI Pharma’s novel anti-Globo H therapeutic cancer vaccine, OBI-833. Title: A phase I cohort expansion trial of OBI-833 in non-small cell lung cancer patients. Session Date and Time: Friday, November 20, 2020.

Vaccine 52

Vaccine Small Molecule Immune Response Hospitals 52

The Pharma Data

NOVEMBER 23, 2020

Third COVID-19 Vaccine Shows Effectiveness. 23, 2020 — On Monday, AstraZeneca announced that late-stage clinical trials of its COVID-19 vaccine showed it to be 70.4 The trials were conducted in the United Kingdom and Brazil in collaboration with the University of Oxford. © 2020 HealthDay. Professional.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

The Pharma Data

NOVEMBER 12, 2020

German drugmaker Curevac says its COVID-19 vaccine candidate, CVnCoV, can remain stable for at least three months at 41 degrees Fahrenheit (5 degrees Celsius), making it easier to distribute than some competitors’ vaccines. The company hopes to launch a phase 3 trial by year’s end. Source link.

Vaccine 52

Vaccine Trials Research 52

The Pharma Data

DECEMBER 8, 2020

AstraZeneca (AZ) and the University of Oxford have presented new data from a “pooled analysis” of phase 3 trials evaluating COVID-19 vaccine AZD1222 at two different dose regimens, demonstrating an average efficacy of 70.4 percent effective “at least 14 days” following the second injection.

Vaccine 52

Vaccine Trials Hospitals Disease 52

The Pharma Data

DECEMBER 12, 2020

Sanofi and GlaxoSmithKline (GSK) have decided to push back the phase 2b trial of their adjuvanted COVID-19 vaccine after finding it produced only a weak immune response in older patients, delaying the potential delivery of a vaccine that could contribute to the mass vaccination effort in the U.S. to vaccinate on demand.

Vaccine 52

Vaccine Immune Response Trials Research 52

The Pharma Data

DECEMBER 7, 2020

China’s Clover Biopharmaceuticals has announced its COVID-19 S Trimer vaccine candidate delivered a “strong immune response” in 150 adult and elderly phase 1 trial participants, with pre-publication results to be released soon.

Vaccine 52

Vaccine Immune Response Trials Research 52

The Pharma Data

DECEMBER 7, 2020

Inovio has dosed the first participant in the phase 2 segment of its phase 2/3 trial evaluating COVID-19 vaccine candidate INO-4800, funded by the Department of Defense (DoD). sites to assess the vaccine’s safety, tolerability and immunogenicity as a two-dose regimen. The Plymouth Meeting, Pa., The Plymouth Meeting, Pa.,

Vaccine 52

Vaccine Trials Research 52

The Pharma Data

SEPTEMBER 23, 2020

September 23, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. NEW BRUNSWICK, N.J.,

Clinical Trials 52

Clinical Trials Vaccine Trials Pharmaceutical Companies 52

The Pharma Data

DECEMBER 21, 2020

22, 2020 07:13 UTC. The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. 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 Mascha Binder, M.D.,

Vaccine 52

Vaccine Trials Clinical Trials Clinical Development 52

The Pharma Data

NOVEMBER 18, 2020

Both Moderna’s and Pfizer’s COVID-19 vaccine candidates could receive Emergency Use Authorization (EUA) in less than a month and be ready for rollout in a matter of weeks, HHS Secretary Alex Azar said Wednesday, giving hope that high-risk patients could receive a vaccine before the year ends.

Vaccine 52

Vaccine Government Immune Response FDA 52

The Pharma Data

OCTOBER 20, 2020

20, 2020 — British scientists are infecting healthy volunteers with COVID-19, in hopes of speeding up vaccine development, TheWashington Post reported Tuesday. Led by scientists at Imperial College London, people in this challenge trial will be guaranteed treatment if they become ill. © 2020 HealthDay. TUESDAY, Oct.

Trials 52

Trials Vaccine Virus Pharmaceutical Companies 52

The Pharma Data

DECEMBER 7, 2020

Inovio has dosed the first participant in the phase 2 segment of its phase 2/3 trial evaluating COVID-19 vaccine candidate INO-4800, funded by the Department of Defense (DoD). sites to assess the vaccine’s safety, tolerability and immunogenicity as a two-dose regimen. The Plymouth Meeting, Pa., The Plymouth Meeting, Pa.,

Vaccine 52

Vaccine Trials Production Research 52