Drug Target Review

JULY 19, 2023

The mad scramble 1 for -80°C freezers during the COVID-19 pandemic is a vivid illustration that we remain unprepared to harness the global potential of vaccine therapeutics. 2 However, it is not just problematic cold chains that limit access to life-saving vaccines.

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The Pharma Data

DECEMBER 20, 2020

UK drug developer Scancell said it has chosen a COVID-19 vaccine candidate, SN14, from more than a dozen potential products to advance to a clinical trial. . SN14 works by targeting the coronavirus’ nucleocapsid and spike proteins to prevent viral replication using the company’s ImmunoBody DNA vaccine technology.

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The Pharma Data

OCTOBER 26, 2020

COVID-19 Vaccine Trials. 26, 2020 — Drugmakers AstraZeneca and Johnson & Johnson are ready to resume paused COVID-19 vaccine trials after health scares, CNN reported. The AstraZeneca trial was stopped in early September, and the Johnson & Johnson trial was paused earlier this month.

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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.

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The Pharma Data

OCTOBER 18, 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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Drug Discovery World

AUGUST 16, 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an updated version of Moderna’s Covid-19 booster vaccine that targets two coronavirus variants. . Known as a bivalent vaccine, Spikevax was approved following data that show it triggers a strong immune response against both Omicron (BA.1) Official comments

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The Pharma Data

MAY 6, 2021

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].

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The Pharma Data

NOVEMBER 10, 2020

Johnson & Johnson (J&J) announced that it has restarted all clinical trials in Europe evaluating its COVID-19 vaccine, Ad26.COV2.S, The clinical trials resuming in Europe this week are phase 2 studies in Germany, the Netherlands and Spain, as well as a phase 1/2 study in Belgium, the company said. . Source link.

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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.

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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.

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PPD

MAY 11, 2023

The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drug developers and the public. The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when.

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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.

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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.

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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.

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Eye on FDA

JANUARY 6, 2021

During 2020, FDA was able to approve 53 – not surpassing the 2018 all time record of 59, but certainly an admirable second place. Notably, the 2020 NME approvals included 22 related to oncology, with 2 new GIST treatments, 3 in breast cancer and 2 approvals in prostate cancer. That, however, was not really the case.

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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.

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Drug Discovery World

APRIL 3, 2024

While the age-adjusted overall cancer death rate in the US fell by 33% between 1991 and 2020, cancer remains a significant threat to human health, with more than two million new cases expected to be diagnosed in 2024 and uneven progress across different cancer types 1.

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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.

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The Pharma Data

NOVEMBER 9, 2020

Pfizer announced that its COVID-19 vaccine candidate, BNT162, was more than 90 percent effective based on early data from 94 participants in a phase 3 trial. Pfizer, which is developing the vaccine along with Germany-based BioNTech, expects to manufacture up to 50 million doses of the vaccine in 2020 and up to 1.3

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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.

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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.

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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.

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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.

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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.

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