Drug Discovery World

DECEMBER 6, 2022

As a result of clear US Food and Drug Administration (FDA) guidelines, the leading vaccine development programmes for Covid-19 were all remarkably similar. Indeed, few randomised trials of NPIs have been undertaken. Quasi-experimental and other randomised trial designs . Pre-specification of effect size .

Drug Development 246

Drug Development Vaccine Drugs Pharmaceuticals 246

The Pharma Data

JANUARY 29, 2021

French vaccine company Valneva said it has begun production of its investigational COVID-19 vaccine, which is now in a phase 1/2 clinical trial in the UK. Valneva also plans to test the vaccine in more than 4,000 patients in additional trials. Martin Berman-Gorvine. Source link.

Vaccine 52

Vaccine Production Clinical Trials Government 52

The Pharma Data

JANUARY 11, 2021

Moderna is following up on the success of its messenger RNA-based COVID-19 vaccine with plans to develop inoculations for numerous other infectious diseases, the company said Monday. based company has been in business for 10 years, but the COVID-19 vaccine was its first approved product. 18, 2020 ). It has already received $2.8

Vaccine 52

Vaccine Clinical Trials Virus RNA 52

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.

Vaccine 96

Vaccine Engineering Disease Virus 96

The Pharma Data

SEPTEMBER 25, 2020

A trial of a new vaccine that appears to train the immune system to fight coronavirus has begun in the UK. The trial on 10,000 people will now see if the vaccine can prevent people getting ill. Some of the vaccines being developed for Covid-19 use either completely new or barely proven technologies. .

Vaccine 52

Vaccine Trials Immune Response Virus 52

The Pharma Data

SEPTEMBER 2, 2020

. 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.

Vaccine 52

Vaccine Trials Immune Response Clinical Trials 52

The Pharma Data

MARCH 11, 2021

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.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

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.

Clinical Trials 52

Clinical Trials Vaccine Pharma Companies Trials 52

The Pharma Data

MARCH 18, 2021

Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) are pleased to announce the start of Phase 3 clinical testing of Medicago’s plant-derived COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant, as part of the ongoing Phase 2/3 study. g of CoVLP are administered 21 days apart.

Vaccine 52

Vaccine Trials Clinical Trials FDA 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

Drug Discovery World

DECEMBER 20, 2023

Centricity Research has acquired North Carolina-based Lucas Research, making it the fifth clinical research company to join Centricity since it launched in November 2021. With this acquisition, Centricity now has more than 35 clinical research sites, reaching 8.5 million geographically and ethnically-diverse patients.

Clinical Research 130

Clinical Research Research Clinical Trials Vaccine 130

The Pharma Data

AUGUST 6, 2020

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.

Vaccine 52

Vaccine Licensing Licensing Immune Response 52

Drug Discovery World

JUNE 7, 2023

Under the leadership of CEO and Founder, Professor Helen McCarthy, pHion has made significant progress since invoX’s initial investment in June 2021, with advances made across all pre-clinical programs and the establishment of a laboratory in Belfast, Northern Ireland for the production of pHion’s mRNA vaccines.

Vaccine 130

Vaccine Testimonials Clinical Trials Laboratories 130

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

JANUARY 31, 2021

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif.

Vaccine 52

Vaccine Trials Virus RNA 52

The Pharma Data

JANUARY 20, 2021

-based Gritstone Oncology is developing a novel COVID-19 vaccine based on adenovirus and messenger-RNA technology designed to combat future variants of the coronavirus.

Vaccine 52

Vaccine RNA Trials Research 52

The Pharma Data

AUGUST 27, 2020

Moderna has announced that its coronavirus vaccine candidate has shown promise in generating an immune response in elderly patients in an early-stage clinical trial. . Each patient was given two 100 microgram doses of the vaccine 28 days apart. There is hope that Moderna’s vaccine could be available by early 2021. .

Vaccine 90

Vaccine Immune Response Clinical Trials Virus 90

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

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

Drug Discovery World

NOVEMBER 7, 2023

Work is underway at The University of Queensland’s (UQ) BASE facility which has become Australia’s leading provider of mRNA for research and pilot studies since its launch in 2021. “We aim to begin manufacturing mRNA for Phase I clinical trials in 2024.”

Clinical Trials 130

Clinical Trials Government Vaccine Laboratories 130

The Pharma Data

OCTOBER 26, 2021

Pfizer and BioNTech SE blazoned topline results from a Phase 3 randomized, controlled trial assessing the efficacity and safety of a 30-µg supporter cure of the Pfizer-BioNTech COVID-19 Vaccine in further than individualities 16 times of age and aged. The observed relative vaccine efficacity of95.6 (95 95 CI89.3,98.6)

Vaccine 52

Vaccine Trials FDA Government 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. The Cambridge, Mass., Source link.

Vaccine 52

Vaccine Trials Research 52

The Pharma Data

JANUARY 13, 2021

Brazil’s Butantan Institute has reported that Sinovac’s COVID-19 vaccine, CoronaVac, demonstrated an overall efficacy of only 50.38 percent in a phase 3 trial, putting it barely over the World Health Organization’s 50 percent efficacy threshold for approval.

Vaccine 52

Vaccine Regulations Trials Research 52

The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

The Pharma Data

NOVEMBER 22, 2021

Pfizer-BioNTech vaccine demonstrated 100 efficacity against COVID-19 in longer- term analysis, with no serious safety enterprises linked. Data will support planned cessions for full nonsupervisory blessing of the vaccine in this age group in theU.S. and worldwide NEW YORK & MAINZ, Germany– (BUSINESS WIRE)– PfizerInc.

Vaccine 52

Vaccine Trials Clinical Trials FDA 52

The Pharma Data

NOVEMBER 17, 2020

Gavi, the Vaccine Alliance welcomes latest pledges in support of the Gavi COVAX AMC , a financing mechanism that will support 92 low- and middle-income economies’ access to safe and effective COVID-19 vaccines. Nine candidate vaccines are currently being supported by CEPI; eight of which are currently in clinical trials.

Vaccine 52

Vaccine Government Clinical Trials Trials 52

The Pharma Data

FEBRUARY 25, 2021

Takeda Provides Updates on Phase 1/2 Clinical Trials of Novavax’ and Moderna’s COVID-19 Vaccine Candidates in Japan. – Takeda is making two COVID-19 vaccines available in Japan, by manufacturing Novavax’ recombinant vaccine candidate and distributing Moderna’s mRNA vaccine candidate, with the support of the Japanese Government.

Clinical Trials 52

Clinical Trials Trials Vaccine Pharmaceutical Companies 52

Drug Discovery World

JULY 25, 2024

United States dominates The United States easily dominates the world biotech sector, with an estimated value share of nearly 59% in 2021 2. In 2021, the country had the seventh largest share of the global biotech market 2. The company is now pursuing a pipeline of mRNA vaccines for cancer, several of which are at the Phase II stage.

Government 130

Government Vaccine Marketing Pharmaceuticals 130

Drug Discovery World

FEBRUARY 10, 2023

Breast cancer retained its position as the most-studied disease area in clinical trials in 2022, despite a drop in activity, according to analysis from analytics company Phesi. With an increase in available vaccines and therapies, it is not surprising that the number of recruiting trials for Covid-19 therapies has fallen.

Disease 130

Disease Clinical Trials Clinical Development Trials 130

The Pharma Data

MAY 3, 2021

Posted 03 May 2021 | By Kari Oakes . The European Medicines Agency (EMA) is evaluating an application submitted by Pfizer and BioNTech for use of their COVID-19 vaccine in children aged 12 to 15 years. . The vaccine has been authorized by the EU for use in people 16 years and up since December 2020. . EMA. . . .

Vaccine 52

Vaccine RNA Packaging Clinical Trials 52

The Pharma Data

AUGUST 7, 2020

AstraZeneca has signed its first deal in China to produce and deliver its vaccine candidate against COVID-19 in the country, partnering up with manufacturing firm Shenzhen Kangtai Biological Products. The partnership stipulates that Shenzhen Kangtai must raise its capacity to deliver 200 million by the close of 2021. Matt Fellows.

Vaccine 88

Vaccine Marketing Trials Production 88

The Pharma Data

AUGUST 13, 2020

The UK government has signed deals for a further 90 million doses of coronavirus vaccine. The vaccines are being developed by the Belgian pharmaceutical company Janssen and the US biotech company Novavax. It means the UK has placed orders for six experimental vaccines, taking its potential stockpile to 340 million doses.

Vaccine 52

Vaccine Virus Government Clinical Trials 52

The Pharma Data

JULY 29, 2021

Second-Quarter 2021 Revenues of $19.0 Billion The 10% Operational Growth Excluding BNT162b2(1) in Second-Quarter 2021 Builds on the 6% Operational Growth Delivered by the Comparable Business in Second-Quarter 2020 Second-Quarter 2021 Reported Diluted EPS(2) of $0.98, Adjusted Diluted EPS(3) of $1.07

Biosimilars 52

Biosimilars Vaccine International Production 52

The Pharma Data

NOVEMBER 17, 2021

AstraZeneca and its partners have released for supply two billion doses of their COVID-19 vaccine to more than 170 countries across every continent on the planet in the last 11 months. 2) From the body of evidence in clinical trials and real-world data, the vaccine has been shown to have an acceptable safety profile.(3,4,5,6,7).

Vaccine 52

Vaccine Virus Clinical Trials Licensing 52

The Pharma Data

JANUARY 11, 2021

In clinical trials, it could detect COVID-19 with 90%+ accuracy in about two minutes. . Testing Therapies, Antivirals and Vaccines. By the end of January, Johnson & Johnson is expected to deliver preliminary trial results for its one-dose COVID-19 vaccine candidate. . Other Industry News.

Vaccine 52

Vaccine Clinical Trials Immune Response Virus 52

The Pharma Data

JANUARY 29, 2021

EU Regulator Approves Oxford-AstraZeneca COVID-19 Vaccine. 29, 2021 — European Union regulators have authorized the AstraZeneca COVID-19 vaccine for use in adults, CBS News reported Friday. The move comes after the European Medicines Agency has been criticized for not moving fast enough to vaccinate its population.

Regulations 52

Regulations Vaccine Hospitals Clinical Trials 52

The Pharma Data

JANUARY 29, 2021

29, 2021 — Interim phase 3 data show that the COVID-19 vaccine developed by Janssen Pharmaceuticals of Johnson & Johnson is 66 percent effective in preventing moderate-to-severe COVID-19 in adults, the National Institutes of Health announced today. The vaccine, known as Ad.26.COV2.S, The vaccine, known as Ad.26.COV2.S,

Vaccine 52

Vaccine Clinical Trials Trials Disease 52