BioPharma Reporter

AUGUST 21, 2022

EMA has begun its review of the conditional marketing authorization application from South Korean developer, SK biosciences, for its COVID-19 vaccine, Skycovion, a recombinant protein-based vaccine with adjuvant from GSK.

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pharmaphorum

NOVEMBER 12, 2020

The European Union has ordered 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine following this week’s landmark announcement that it was effective in more than 90% of patients. Vaccine doses for Europe will be produced in BioNTech’s German manufacturing sites, as well as in Pfizer’s manufacturing site in Belgium.

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Vaccination Vaccine Manufacturing Regulation 105

pharmaphorum

MARCH 3, 2021

Novavax hopes its COVID-19 vaccine could be filed in the US in the second quarter, following a potential approval from the UK regulator in the coming weeks. Novavax’s vaccine is a sequence of protein engineered from the genetic sequence of the SARS-CoV-2 virus that mimics the “Spike” protein found on the pathogen’s surface.

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pharmaphorum

SEPTEMBER 2, 2022

The EMA’s human medicines committee (CHMP) has recommended authorisation of two COVID-19 vaccines from Moderna and Pfizer/BioNTech that include sequences coding for Omicron spike protein as booster shots. The FDA has just authorised vaccines from the two companies that will specifically target the BA.4 Moderna’s BA.1

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BioPharma Reporter

DECEMBER 20, 2021

The European Commission has granted conditional marketing authorisation to Novavax for its COVID-19 vaccine: making it the first protein-based COVID-19 vaccine in the EU.

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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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XTalks

JULY 2, 2021

There have been growing reports of women experiencing changes in their menstrual cycle after receiving a shot of a COVID-19 vaccine. Some women have said they got their periods early following vaccination, or that their periods were unusually heavy and/or painful. Related: Moderna’s COVID-19 Vaccine Effective Against New Variants.

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Vaccination Vaccine Protein Immune Response 105

pharmaphorum

SEPTEMBER 7, 2020

A trial of Russia’s Sputnik V coronavirus vaccine has shown the jab produces an immune response, although the study was too small to produce conclusive findings, particularly on safety. The vaccine also produced a T-cell response within 28 days, a secondary outcome.

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pharmaphorum

DECEMBER 22, 2020

BioNTech CEO Ugur Sahin has said that it is “highly likely” the company’s COVID-19 vaccine will work against the more infectious strain circulating in the south east of England, although further studies will be needed. Sahin said: “We don’t know at the moment if our vaccine is also able to provide protection against this new variant.

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pharmaphorum

JUNE 9, 2022

Moderna’s new version of its COVID-19 vaccine, which targets two virus variants including Omicron, has outperformed the company’s original Spikevax shot in a head-to-head clinical trial. It has predicted sales of COVID-19 vaccines will be around $21 billion this year. Three-month data will be reported later this summer.

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pharmaphorum

SEPTEMBER 17, 2020

US medical experts are reportedly concerned that a neurological side effect picked up in AstraZeneca’s closely-watched COVID-19 vaccine trial could compromise the whole project, as the FDA weighs whether to give the go ahead for US studies to resume. The post US experts stress over safety of AZ’s COVID-19 vaccine appeared first on.

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BioPharma Reporter

DECEMBER 11, 2020

Sanofi and GSK announced a delay on Friday in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly, saying clinical trials showed an insufficient immune response in older people.

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pharmaphorum

JUNE 30, 2021

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. . The post Altimmune ditches nasal COVID vaccine on weak trial data appeared first on.

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Pharmaceutical Technology

FEBRUARY 1, 2023

Pharmaceutical companies have been working on developing vaccines and other prophylactics for respiratory syncytial virus (RSV) since its discovery in 1956. Despite strong efforts and scientific advances, a safe and effective vaccine for RSV has yet to be approved for any patient population.

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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

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease.

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Vaccination Vaccine Immune Response Trials 105

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

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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pharmaphorum

FEBRUARY 5, 2021

Johnson & Johnson’s Janssen unit has filed its single dose COVID-19 vaccine candidate with the FDA, asking for an Emergency Use Authorization (EUA). The European Medicines Agency (EMA) has already begun a rolling review of the vaccine, allowing for a faster decision if data is supportive.

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XTalks

NOVEMBER 23, 2021

Canadian pharma and biotech contract development and manufacturing organization (CDMO) Biovectra has announced plans for building one of the first state-of-the-art mRNA vaccine and biomanufacturing facilities in Canada. Related: Medicago’s Plant-Based COVID-19 Vaccine Enters Human Trials. million, respectively.

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pharmaphorum

OCTOBER 27, 2020

Russia’s sovereign wealth fund has filed applications with the World Health Organization (WHO) that if approved could see the Sputnik V coronavirus vaccine backed for use in many countries around the world. The vaccine is based on two adenovirus vectors (Ad5 and Ad26) fused with the spike protein from the SARS-CoV-2 coronavirus.

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pharmaphorum

MAY 7, 2021

Reports are emerging that the UK may join other countries in imposing restrictions on the use of AstraZeneca’s COVID-19 vaccine in younger people, after a fresh look at the risks and benefits of the shot. . million first doses of the vaccine had been given, with 5.9 That’s an increase on the earlier estimate of 9.3

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Vaccination Vaccine Regulation Protein 130

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

APRIL 12, 2021

The coronavirus variant discovered in South Africa may evade Pfizer/BioNTech’s vaccine, according to a real-world data study conducted in Israel. But among patients who had received two doses of the vaccine, the variant’s prevalence was eight times higher than in unvaccinated people – 5.4% Known as variant B.1.351, versus 0.7%.

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Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

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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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Pharmaceutical Technology

APRIL 11, 2023

In August 2021, Zydus secured emergency use authorisation (EUA) from the Drugs Controller General of India for its Covid-19 deoxyribonucleic acid (DNA) plasmid vaccine, ZyCoV-D. The vaccine, which generates the SARS-CoV-2 viral spike protein on administration, induces the immune system’s cellular and humoral arm-mediated immune response.

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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

SEPTEMBER 25, 2020

Novavax has begun a late-stage trial of its experimental COVID-19 vaccine in the UK, which could support filings for a licence in the UK, EU and other countries. The UK government has already signed an agreement with the US biotech to buy 60 million doses of the vaccine in August if trials work out.

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pharmaphorum

JANUARY 29, 2021

Novavax’s COVID-19 vaccine could be added to the UK’s growing arsenal of shots against the disease after it showed 89.3% The UK government has 60 million doses of the vaccine on order if approved by regulators and much of the shot will be manufactured at Novavax’s UK factory in Billingham, Stockton-on-Tees.

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Vaccination Vaccine Regulation Trials 105

XTalks

JUNE 30, 2021

is offering a comprehensive diagnostic for COVID-19 vaccine-induced blood clot testing to help in the accurate and prompt diagnosis of the rare but serious blood clots being seen after some individuals are vaccinated with viral vector COVID-19 vaccines such as those from AstraZeneca and Johnson & Johnson.

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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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pharmaphorum

FEBRUARY 24, 2021

The FDA has issued guidelines allowing for faster development of updated coronavirus vaccines, based on previously approved shots that have been tweaked to combat emerging variants of the SARS-CoV-2 virus. If vaccines need updating, the FDA expects that manufacturing information will remain generally the same.

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XTalks

OCTOBER 8, 2024

The 2024 Nobel Prize in Physiology or Medicine has been awarded to American scientists Victor Ambros and Gary Ruvkun for their groundbreaking discovery of microRNA (or miRNA) and its role in post-transcriptional gene regulation. However, microRNAs can bind to this mRNA, preventing it from functioning.

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pharmaphorum

MARCH 30, 2022

CureVac and GlaxoSmithKline’s first attempt to develop a COVID-19 vaccine was a salutary reminder of the pitfalls in drug development, as the mRNA shot crashed and burned in a clinical trial last year, but they aren’t giving up. ” The post CureVac and GSK try again with COVID-19 vaccine appeared first on.

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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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pharmaphorum

MARCH 19, 2021

Now the Ireland-based firm said that early data from studies shows the system can detect and identify the COVID virus S-Protein in quantities at 40 femtograms per millilitre at close to 100% specificity. A femtogram is 0.000000000000000001 kilograms.

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