pharmaphorum

AUGUST 11, 2020

Russia has become the first country in the world to approve a coronavirus vaccine, amid scepticism from international experts who have been unable to review or verify clinical data from the jab called ‘Sputnik V’ According to press reports the vaccine has been tested on one of President Vladimir Putin’s daughters.

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XTalks

MARCH 1, 2021

(NYSE: PFE ) and BioNTech SE (Nasdaq: BNTX ) have announced that they are beginning a trial to evaluate the safety and efficacy of a third booster dose for their COVID-19 vaccine (BNT162b2), as well as new vaccine variants. Related: Could Pfizer and BioNTech’s COVID-19 Vaccine be Stored at Standard Freezer Temperatures?

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BioPharma Reporter

MARCH 3, 2021

Convergence towards common global standards for clinical trial application (CTA) rules, along with unilateral and mutual recognition of CTA approvals are some suggestions made by industry insiders in a new paper to enable robust and timely development of vaccines.

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Clinical Development Vaccination Vaccine Development 52

pharmaphorum

NOVEMBER 17, 2020

Pfizer has begun a pilot delivery programme in the US for its experimental COVID-19 vaccine, as the company seeks to overcome logistical challenges caused by its ultra-cold storage requirements. The vaccine developed in partnership with Germany’s BioNTech has been shown to be 90% effective in clinical trials.

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pharmaphorum

DECEMBER 7, 2020

China’s Sinovac has raised $515 million to increase its distribution and production capacity as clinical development of its potential coronavirus vaccine nears conclusion. Sinovac has a coronavirus vaccine in late-stage development, which is undergoing large-scale trials in Brazil, Pakistan, Indonesia and Chile.

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pharmaphorum

FEBRUARY 19, 2021

billion doses of its COVID-19 vaccine to the COVAX global initiative led by Gavi, the vaccine alliance, which aims to ensure fair access across the globe. There are growing concerns about the lack of COVID vaccines available to poorer countries. billion COVID shots to global vaccine drive appeared first on.

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VirTrial

OCTOBER 25, 2023

Vaccine studies can be large, multinational endeavors with sensitive timeframes, extended participation follow-up periods, multiphase designs, and critical data management needs. In recent years, Signant has been a part of more than 95 vaccine studies involving 140,000+ patients in more than 30 countries.

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Vaccination Vaccine Development Clinical Trials 52

pharmaphorum

NOVEMBER 9, 2020

As the death toll from COVID19 inexorably mounts, Pfizer and BioNTech have announced that their COVID-19 vaccine candidate is more than 90% effective at countering the disease in an interim analysis. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

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Vaccination Vaccine Clinical Trials Clinical Trials 98

BioPharma Reporter

AUGUST 13, 2020

CureVac files to raise upward of $200 million in Nasdaq IPO to fund clinical development of COVID-19 vaccine.

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Vaccination Vaccine Development Clinical Development 90

pharmaphorum

MARCH 2, 2022

Pfizer’s vaccine for Clostridium difficile (C. Top-line efficacy for the vaccine was 49% at 12 months, 47% at 24 months and 31% at final analysis, said the drugmaker, which was forced to carry out the assessment after 42 cases of CDI, fewer than the 66 cases laid out in the trial protocol. With no approved vaccines to date, C.

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pharmaphorum

AUGUST 21, 2020

Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial. The latest data from a phase 1 study in the US showed that seven days after a second dose at 30 micrograms, the vaccine produced 3.8

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pharmaphorum

MARCH 22, 2021

With its vaccine roll-out in chaos after last week’s safety alert, Europe is reportedly on the brink of a vaccine war with the UK by threatening to block exports of the AstraZeneca COVID-19 shot. The issue emerged after data from the delayed US trial of the vaccine showed it was safe and more effective than expected.

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Vaccination Vaccine Trials Clinical Development 57

pharmaphorum

OCTOBER 6, 2020

The European Medicines Agency has begun a second “rolling review” of a potential coronavirus vaccine jointly developed by BioNTech and Pfizer, setting up a race with a rival from AstraZeneca and Oxford University. The post Race for COVID-19 vaccine hots up as EMA begins review of BioNTech/Pfizer jab appeared first on.

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pharmaphorum

NOVEMBER 10, 2020

The UK’s NHS is ready to start rolling out a coronavirus vaccine, likely beginning in the new year, according to health secretary Matt Hancock. In an interview with the BBC Hancock said that the vaccine could be available by Christmas, but he expected a mass roll out “in the first part of the new year”.

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Vaccination Vaccine Regulation Trials 57

Pharmaceutical Technology

JANUARY 2, 2023

BI-1361849 is under clinical development by Boehringer Ingelheim International and currently in the Phase II in clinical pathway. It offers a wide range of products including human diseases, animal health care products and biopharmaceuticals.

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pharmaphorum

APRIL 26, 2022

There’s only one vaccine candidate for tick-borne infection Lyme disease in clinical development – Valneva and Pfizer’s VLA15 – and it has just moved another step closer to being available. There’s no guarantee of revenues for the COVID-19 shot from the UK however as the government there backed out of a $1.5

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The Pharma Data

MAY 7, 2021

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.

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Licensing Licensing Vaccination Vaccine 52

The Pharma Data

OCTOBER 19, 2020

.–( 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. among adults 65 years of age or older.

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pharmaphorum

DECEMBER 11, 2020

Sanofi and GlaxoSmithKline have said their COVID-19 vaccine has hit a snag in clinical development, prompting analysts to note this could delay delivery of potentially more than a billion shots globally by up to nine months. AZ to combine vaccine with Russian rival.

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The Pharma Data

SEPTEMBER 9, 2020

The vaccine supply for the EU would be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium. Deliveries would be starting by the end of 2020, subject to clinical success and regulatory authorization. billion doses by the end of 2021. CEO and Co-founder of BioNTech.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

pharmaphorum

JANUARY 21, 2021

While restrictions on travel could prevent coronavirus transmission in the short term, digital passports showing COVID-negative and vaccination status may help reopen airports and other badly hit areas of the economy, reports Richard Staines. But getting the technology to work is taking time.

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Vaccination Vaccine Development Trials 84

Drug Discovery World

SEPTEMBER 14, 2023

Vaccines were up 9.1% Moreover, in July 2023, AstraZeneca and Vaxess Technologies commenced a collaboration for the evaluation of a novel RNA-based pandemic influenza prototype vaccine in patch format. Regulatory developments There were several noteworthy developments across Pfizer’s pipeline, which were covered by DDW.

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Drugs Vaccination Vaccine Medicine 59

pharmaphorum

MAY 14, 2021

China’s Kintor Pharmaceutical has begun late-stage US clinical development of its potential COVID drug proxalutamide – but there is scepticism over the company’s claims about its research. Reuters also pointed to other links with one of the study authors and Brazil’s vaccine sceptic president, Jair Bolsonaro.

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pharmaphorum

SEPTEMBER 18, 2020

All eyes may be on Moderna’s COVID-19 vaccine at the moment, but the US biotech hasn’t been idle in business development elsewhere, signing back-to-back deals with Vertex and Chiesi that have brought in $100 million upfront. .

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Gene Editing Gene Vaccination Vaccine 104

pharmaphorum

JULY 5, 2021

Parexel has been a champion of the concept for years, but while adoption was fairly slow pre-COVID, it has accelerated at a fast pace since the crisis, aided by the increasing willingness of regulators to accept decentralised trial data in marketing applications.

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Clinical Trials Clinical Trials Regulation Trials 62

pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine. About the author.

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Clinical Trials Clinical Trials Trials Clinical Research 109

XTalks

DECEMBER 24, 2020

From isolating SARS-CoV-2 in early January to sequencing its genome shortly thereafter and having a prototype vaccine against it within days, scientific process and progress have held steadfast throughout the pandemic. For example, investment in mRNA vaccines and viral vectors came well before January, many years before it.

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XTalks

MAY 20, 2021

As physicians’ offices and primary care centers sought to limit the number of people passing through their doors — turning instead to telehealth wherever possible — almost all realms of healthcare and medical research, including clinical trials, were affected, with many temporarily halting new patient recruitment and dosing.

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Clinical Trials Clinical Trials Trials Vaccination 105

pharmaphorum

SEPTEMBER 8, 2021

billion to take control of its mRNA vaccine partner Translate Bio. The orally-active drug can be used in patients aged 12 and over after two other systemic therapies have been tried, and is thought to work by downregulating inflammatory immune cells and boosting the levels of T cells that help to regulate the immune system.

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Drugs Sales Immune Response Marketing 52

Delveinsight

AUGUST 25, 2021

The pharmaceutical industry finds, develops, manufactures, and promotes medicines or pharmaceutical drugs for usage as medications that are administered (or self-administered) to patients in order to cure, vaccinate, or relieve symptoms. billion through the vaccines. The global healthcare spending in 2020 was USD 8.3

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The Pharma Data

DECEMBER 14, 2020

“Filing an IND with the FDA is an important step in the clinical development of Rabeximod. It is a quality stamp on our drug candidate and Covid-19 trial and would enable us to expand the clinical development to the United States. About Cyxone.

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Clinical Trials Clinical Trials Clinical Development Drugs 52

The Pharma Data

SEPTEMBER 8, 2020

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.

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pharmaphorum

SEPTEMBER 24, 2020

The UK could be the first country to carry out a COVID-19 “challenge trial” where healthy volunteers are deliberately infected with coronavirus to test vaccines, according to press reports. That vaccine is top of the World Health Organization’s list of vaccines in clinical development, which shows there are 38 potential shots in human trials.

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The Pharma Data

SEPTEMBER 8, 2020

— 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.

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XTalks

OCTOBER 18, 2022

A clinical research organization (CRO) is a company that delivers outsourced services to plan, manage and execute clinical trials for biotechnology, pharmaceutical, and medical device companies. Infectious diseases and vaccines. The PACE Training Program includes: US Food and Drug Administration (FDA) regulations.

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Clinical Research Research Clinical Trials Clinical Trials 111

pharmaphorum

FEBRUARY 22, 2021

Sanofi and GlaxoSmithKline are restarting clinical development of their COVID-19 vaccine, which was delayed after hitting a snag late last year. In December interim phase 1/2 trial results showed the vaccine produced a lower immune response in older adults.

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XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. Tension is mounting as nations big and small jockey around industry to ensure they are first in line to access a vaccine, should one prove to be successful against COVID-19. Moderna’s COVID-19 Vaccine. The price of that prize is incalculable.

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