pharmaphorum

DECEMBER 24, 2020

The UK’s COVID-19 vaccination programme could get a speed boost, with the country’s drugs regulator expected to make a decision on a shot from Oxford University/AstraZeneca in the next few days. Just how this will be viewed by regulators is unclear, as are the plans to distribute the vaccine.

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pharmaphorum

DECEMBER 2, 2020

Pfizer and BioNTech are preparing to deliver their COVID-19 vaccine to the UK after the country’s drugs regulator became the first authority in the world to approve it. Distribution will be prioritised – the Joint Committee on Vaccine and Immunisation has already set out priority groups who will receive the vaccine.

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pharmaphorum

DECEMBER 7, 2020

Tuesday has been dubbed “V-day” in the UK, when the first doses of Pfizer/BioNTech’s coronavirus vaccine will be distributed to the public outside of a clinical trial. Health secretary Matt Hancock reportedly came up with the wartime analogy to describe what will be the largest scale vaccination programme in the country’s history.

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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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pharmaphorum

MAY 11, 2021

Novavax has finally provided some clarity about when its long-awaited COVID-19 vaccine will be ready, saying regulatory filings in the US, UK and Europe are due in the third quarter. The vaccine could play an important role in the next stage of the pandemic as phase 3 trials have shown encouraging safety and efficacy data.

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Drug Discovery World

APRIL 11, 2023

US-based start-up Atomic AI is using artificial intelligence (AI) to design more intelligent RNA-targeted and RNA-based medicines. As tech experts call for improved regulation and a halt to the development of AI, we take a look at how one company, Atomic AI, is using it to develop RNA-targeting treatments for a range of diseases.

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pharmaphorum

DECEMBER 1, 2020

Pfizer and BioNTech have filed their COVID-19 vaccine with the European medicines regulator, paving the way for a potential approval before the end of the year. Despite the fast review, the company insisted that the potential vaccine will be assessed according to the EMA’s normal standards for quality and safety.

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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

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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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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Drug Discovery World

AUGUST 16, 2023

Samir Ounzain , PhD, CEO & Co-Founder of HAYA Therapeutics, looks at how a better understanding of our DNA can lead to increased activity for RNA therapeutics. The whole world realised the power of RNA when the Covid-19 pandemic brought us the first mRNA-based vaccines.

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pharmaphorum

APRIL 13, 2021

England is beginning its rollout of the Moderna COVID-19 vaccine, offering an alternative to the AstraZeneca/Oxford University jab following a potential link to a very rare kind of blood clot. The Moderna shot is the third vaccine to become available in the country, which has made considerable progress with its inoculation campaign.

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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. A further 1.8

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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. To date, the trial has enrolled approximately 37,000 participants with more than 28,000 having received their second vaccination.

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BioPharma Reporter

FEBRUARY 27, 2023

The Boston-based messenger RNA (mRNA) specialist Moderna revealed $19.3bn in revenues last year, but rising costs and falling demand for its COVID-19 vaccine cut into its earnings in the fourth quarter of 2022.

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The Pharma Data

MAY 7, 2021

During an early May meeting, the European Medicines Agency’s safety committee concluded two reviews of safety signals related to COVID-19 vaccines, while it continued following other vaccine-related “topics of interest.” These included reports of heart muscle inflammation after receipt of the Pfizer-BioNTech vaccine. .

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pharmaphorum

NOVEMBER 23, 2020

AstraZeneca is preparing to file its COVID-19 vaccine with regulators after phase 3 trial results showed it is up to 90% effective. AZ made the announcemen t as the UK regulator reportedly gears up to make a decision on the rival vaccine from Pfizer and BioNTech, ahead of counterparts in the US and Europe.

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pharmaphorum

JANUARY 5, 2022

A COVID-19 vaccine that could work against multiple variants of the coronavirus – developed by US biotech Gritstone bio – has generated encouraging immune response data in its first clinical trial. “But it may be; and if it doesn’t other novel vaccines with similar benefits may well take on this role.”

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The Pharma Data

MAY 17, 2021

Sanofi and GlaxoSmithKline (GSK) have reemerged as COVID-19 vaccine contenders after their reformulated candidate delivered a strong immune response across all age groups in a phase 2 study. And if the results are positive, the companies expect to seek approval from regulators in the fourth quarter. 14, 2020 ). Jason Scott.

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The Pharma Data

MARCH 5, 2021

Novartis announced today that it has signed an initial agreement to manufacture the mRNA and bulk drug product for the COVID-19 vaccine candidate CVnCoV from CureVac to aid in the fight against the COVID-19 pandemic. Preparations for the start of production, technology transfer and test runs are already underway.

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pharmaphorum

NOVEMBER 25, 2020

AstraZeneca’s research chief has said that the more effective dosing regimen of its coronavirus vaccine was discovered by accident. According to Reuters , the AstraZeneca development team made a minor mistake that made them realise they could significantly boost the success rate of the vaccine, codenamed AZD1222.

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The Pharma Data

DECEMBER 18, 2020

Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. Hahn , M.D.

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The Pharma Data

NOVEMBER 16, 2020

We believe that our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our COVID-19 vaccine candidate at temperatures commonly found in readily available pharmaceutical freezers and refrigerators,” said Juan Andres, Chief Technical Operations and Quality Officer at Moderna. “We

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STAT News

MARCH 6, 2023

Still, when doctors told her last year that the cancer was growing despite two operations, radiation therapy, and a fifth regimen of chemotherapy, the retired business-meeting facilitator decided to do something unorthodox: spend $83,000 out of pocket on an unproven experimental cancer vaccine. Another three received them but later died.

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pharmaphorum

DECEMBER 16, 2020

Moderna looks odds on to claim emergency use authorisation from the FDA for its COVID-19 vaccine this week, after the regulator published a report endorsing its safety and rating its efficacy at 94.5%. Both vaccines will be provided free of charge to recipients.

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The Pharma Data

JANUARY 6, 2021

Under the terms of the agreement, Bayer will support the further development, supply and key territory operations of CureVac’s COVID-19 vaccine candidate CVnCoV. “The need for vaccines against COVID-19 is enormous. “We are highly committed to making our capabilities and networks available to help end this pandemic.”

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pharmaphorum

DECEMBER 21, 2020

Moderna and BioNTech, two rising stars in biotech, were in the limelight this year with their pioneering mRNA vaccines against COVID-19. But the tragic events of 2020 have meant these companies have become household names as their trailblazing mRNA vaccines became the first to be approved by regulators against the COVID-19 scourge.

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Delveinsight

SEPTEMBER 23, 2021

That deal, signed in 2014, had aimed to convey most cancer mRNA vaccines to the marketplace. 858 Therapeutics closes USD 60 Million series A round to drug RNA modulation. Now, they are ready for their next venture, which is launching RNA biotech 858 Therapeutics with a USD 60 million Series A fundraising. Jeffrey Stafford, Ph.D.,

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Pharmaceutical Technology

DECEMBER 9, 2022

Solvias has extensive experience with analytical method development and testing for mRNA-based vaccines as well as monograph testing of excipients and APIs according to Ph Eur or USP. Assays to support mRNA-based Covid-19 vaccines. However, messenger RNA (mRNA) based vaccines present particular analytical challenges.

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pharmaphorum

JANUARY 20, 2021

UK biotech ConserV Bioscience has joined with California’s Lawrence Livermore National Laboratory to develop broad-spectrum coronavirus vaccines as concerns mount over potentially more infectious strains emerging in the UK, South Africa and Brazil. Feature image courtesy of Rocky Mountain Laboratories/NIH.

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Drug Discovery World

JANUARY 11, 2024

Researchers have used messenger RNA (mRNA) to create an effective therapy for a rare liver disease in preclinical studies, demonstrating the technology’s potential therapeutic use in people. Patients affected by the disease are found to also experience an imbalance of glutathione regulation, which is important for liver detoxification.

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Roots Analysis

OCTOBER 30, 2023

In the past few years, Next Generation RNA therapeutics have emerged as one of the key therapeutic modalities in the modern healthcare industry. These RNA based therapeutics play a crucial role in protein production and regulation of gene functions.

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pharmaphorum

JANUARY 5, 2022

The year 2020 ended on a note of hope, with the 8th December vaccination of 91-year-old Margaret Keenan, the world’s first person to receive a COVID-19 vaccine outside clinical trials. Add to this the fact that the world missed the WHO targets for global vaccination by the end of 2021 and will likely continue to miss targets in 2022.

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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. Specialty care grew 11.8% Chris Boshoff, M.D., As a result of these moves, William Pao, M.D.,

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Drugs Vaccination Vaccine Medicine 59

XTalks

MAY 5, 2023

This week, the US Food and Drug Administration (FDA) approved the world’s first respiratory syncytial virus (RSV) vaccine. GSK says the RSV vaccine will be available for older adults before this year’s RSV season, which usually starts before the winter months. RSV is a negative-strand RNA virus that was first identified in 1955.

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pharmaphorum

JULY 19, 2021

Drugs harnessing the potential of modified RNA, antisense and siRNA oligonucleotides, antibody–drug conjugates and nanomedicines will become as important as today’s ‘small molecule’ drugs, reaching potential market values into the hundreds of billions – if the potential can be realised through innovation support and industry collaboration.

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Pharmaceutical Technology

OCTOBER 28, 2022

Protein-based drugs are extremely expensive and so if you can create a biosimilar and potentially lower the cost, then this is an incentive for many companies to try to get into that marketplace, but also for regulators to encourage development.”. For more information, please download our white paper.

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