pharmaphorum

JANUARY 15, 2021

J&J has announced early trial results that suggest its single-shot coronavirus vaccine provides a sustained response against the virus ahead of a phase 3 trial readout due later this month. J&J expects to file with the FDA first, followed by other regulators.

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Vaccination Vaccine Immune Response Antibody 119

pharmaphorum

DECEMBER 4, 2020

Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter of 2021. Pfizer will pay up to $45 million in development related milestone payments and up to $143 million if the vaccine hits early sales targets.

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Vaccination Vaccine Bacterium Protein 119

pharmaphorum

JANUARY 6, 2023

The UK has formed an partnership with German biotech BioNTech to provide up to 10,000 patients with access to personalised cancer therapies, in another example of the country embracing the mRNA technologies that underpinned COVID-19 vaccines. It will also cover some infectious disease targets.

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Clinical Trials Clinical Trials Trials Vaccination 111

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

FEBRUARY 8, 2021

China’s national regulator has approved Sinovac Biotech’s COVID-19 vaccine for use by the general public. This is the second vaccine approved by China’s National Medical Products Administration (NMPA). Both of the vaccines, along with another experimental vaccine from Sinopharm, have been used in China’s vaccination programme.

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Vaccination Vaccine Immune Response Regulation 90

The Pharma Data

SEPTEMBER 14, 2020

. AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA). Source link.

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Vaccination Vaccine Trials Immune Response 52

Advarra

JANUARY 11, 2024

While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines. The mRNA constructs used in COVID-19 vaccines, for example, direct cells to produce a version of the “spike” protein studding the surface of SARS-CoV-2.

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Vaccination Vaccine Protein Antibody 52

pharmaphorum

SEPTEMBER 29, 2020

Inovio Pharma’s plan to start pivotal testing of its COVID-19 vaccine has been delayed by FDA requests for more information, sending its shares into a swift decline. An expanded phase 1 trial of the shot is still ongoing and unaffected by the partial hold.

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Vaccination Vaccine Trials DNA 52

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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Immune Response Trials Vaccination Vaccine 72

pharmaphorum

NOVEMBER 19, 2020

The coronavirus vaccine being developed by Oxford University and AstraZeneca produces a strong immune response in higher risk older patients, a study has found. Although both vaccines are not yet approved by regulators, the results are encouraging as older people seem to be most at risk from the virus.

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Immune Response Vaccination Vaccine 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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Vaccination Vaccine Regulation Immune Response 130

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

STAT News

OCTOBER 19, 2022

… Moderna disclosed that its Covid-19 vaccine booster targeting the BA.1 1 subvariant of Omicron generated a strong immune response against that variant, with antibody levels staying high for at least three months , Reuters notes. Omicron-tailored 5 targeted vaccine later this year. 5 subvariants of Omicron.

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Immune Response Scientist Vaccination Vaccine 98

XTalks

APRIL 2, 2021

Pfizer released new COVID-19 vaccine trial results this week from its ongoing clinical studies, which include data showing that its COVID-19 mRNA vaccine is 100 percent effective in children between the ages of 12 and 15 and has a 91 percent efficacy against variants with protection lasting at least six months.

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Vaccination Vaccine Trials Clinical Trials 59

pharmaphorum

MARCH 4, 2021

UK chancellor Rishi Sunak has announced a budget loaded with initiatives designed to kick-start the UK’s economy as it recovers from the coronavirus pandemic, with vaccine development, pharma and life sciences playing a key role. The post Budget 2021: Sunak focuses on vaccine development to restart economy appeared first on.

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Vaccination Vaccine Development Life Science 105

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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Protein Vaccination Vaccine Immune Response 126

pharmaphorum

APRIL 6, 2021

People in the UK will start receiving doses of Moderna’s COVID-19 vaccine in around two weeks’ time, according to vaccines minister Nadhim Zahawi. Moderna’s vaccine is around 94% effective at preventing the disease, in line with the results seen from the Pfizer/BioNTech shot, which is also based around mRNA technology.

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Vaccination Vaccine Immune Response Manufacturing 80

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

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 ).

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Vaccination Vaccine Immune Response RNA 40

pharmaphorum

MARCH 17, 2021

At the start of the pandemic GlaxoSmithKline made its vaccine booster tech available looking for collaborations with other vaccine developers – but GSK has been lagging behind rivals like Pfizer and AstraZeneca after its big tie-up with Sanofi hit technical troubles. micrograms of the vaccine are administered 21 days apart.

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Vaccination Vaccine Immune Response Trials 105

The Pharma Data

JUNE 17, 2022

In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

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. In the case of a rolling review, the EMA evaluates trial data as they become available before a complete filing is submitted.

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Vaccination Vaccine RNA Immune Response 59

XTalks

FEBRUARY 3, 2021

COVID-19 vaccines have been a topic of conversation since the outbreak began, and last year’s US Food and Drug Administration (FDA) approval of the Pfizer/BioNTech and Moderna vaccines have given the world hope to defeat the COVID-19 pandemic. One country that has already vaccinated 1.8 Combating COVID-19 Vaccine Misinformation.

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Vaccination Vaccine Immune Response Manufacturing 98

pharmaphorum

FEBRUARY 18, 2021

The South African coronavirus variant may cut the effectiveness of Pfizer/BioNTech’s vaccine by around two thirds, according to a laboratory study. Mutations may alter neutralisation by affecting spike function rather than antigen response and its also unclear from this study how the T-cell response is affected.

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Immune Response Genetic Engineering Vaccination Vaccine 52

The Pharma Data

DECEMBER 11, 2020

11, 2020 — More than 15 million Americans have been infected by the COVID-19 virus, and many may be questioning whether they need to receive one of the two coronavirus vaccines now on the verge of approval from U.S. regulators. A recent COVID-19 infection could put a person a bit farther back in line for the vaccine, however.

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Vaccination Vaccine Immune Response Trials 52

pharmaphorum

AUGUST 16, 2021

Pfizer and BioNTech have formally asked for FDA approval of a third dose of their COVID-19 vaccine BNT162b2 in people aged over 16, as the US prepares to get its booster campaign underway. Mixing of the two mRNA vaccines is permitted for the third shot if the original vaccine received by a person is not available, according to the agency.

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FDA Approval Vaccination Vaccine Antibody 105

pharmaphorum

APRIL 27, 2021

Following the success of the coronavirus vaccine developed with AstraZeneca, Oxford University’s Jenner Institute has unveiled trial results showing its experimental malaria shot could be around 77% effective. Vaccine efficacy was 74% and 77% in the low and high dose adjuvant group, respectively.

Vaccination 52

Vaccination Vaccine Immune Response Trials 52

pharmaphorum

MAY 18, 2021

Canadian biotech Medicago has the data it was hoping for from a phase 2 trial of its COVID-19 vaccine, partnered with GlaxoSmithKline, and is now hoping to have phase 3 data available “by early summer.” The purified vaccine is administered alongside GSK’s pandemic adjuvant to boost the immune response.

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Immune Response Vaccination Vaccine Gene Sequencing 64

pharmaphorum

AUGUST 31, 2021

As a top vaccine maker, GlaxoSmithKline has been a laggard in the COVID-19 vaccine race, but has put on a late burst of speed with a start of phase 3 trials of a second candidate that will be compared directly to the AstraZeneca shot. GBP510 is the second COVID-19 vaccine with which GSK is involved.

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Vaccination Vaccine Protein Immune Response 59

The Pharma Data

MARCH 25, 2021

European Medicines Agency to Conduct First-Ever Parallel Assessment of a Medicinal Product, Takeda’s Dengue Vaccine Candidate (TAK-003), for use in the EU; Countries Outside of the EU through the EU-M4all (Previously Article 58) Procedure.

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Vaccination Vaccine Medicine Trials 52

pharmaphorum

JUNE 14, 2021

The top-line phase 3 data for Novavax’ COVID-19 vaccine look good, with a 90% overall efficacy rate, but a dip in its share price indicates investors fear it could be too late for the programme. billion doses are due to go to the COVAX programme, which distributes vaccines to poorer countries.

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Vaccination Vaccine Immune Response Protein 84

pharmaphorum

FEBRUARY 16, 2021

UK health chiefs have urged caution over any relaxation of lockdown rules amid signs that the impact of vaccination and social distancing regulations are beginning to work. The figures emerged as plans were announced to begin a new trial of the Oxford University/AstraZeneca vaccine in children.

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Vaccination Vaccine Immune Response Trials 59

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.

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Vaccination Vaccine Drugs Clinical Trials 98

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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Vaccination Vaccine Immune Response Containment 52

pharmaphorum

OCTOBER 26, 2021

FDA advisors will meet later today discuss the possibility of authorising Pfizer and BioNTech’s COVID-19 vaccine Comirnaty in children as young as five years old. Moderna has said it plans to submit the new data to global regulators including the EMA and FDA shortly. As of 21 October, nearly 6.3

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Vaccination Vaccine Immune Response Clinical Trials 64

pharmaphorum

SEPTEMBER 25, 2020

Leap Therapeutics will get a swift FDA review for its lead drug DKN-01 for a form of gastric and gastroesophageal junction (G/GEJ) cancer after being awarded fast-track status by the regulator. In animal models, neutralising DKK1 has been shown to activate an innate immune response against malignant cells.

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Immune Response Trials Drugs Containment 72

The Pharma Data

NOVEMBER 24, 2020

AstraZeneca’s COVID-19 vaccine candidate will undergo increased scrutiny by regulators because of the promising but confusing interim analysis results from a late-stage trial that found a one-and-a- half-dose regimen — given by mistake — was significantly more effective than a full double dose.

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Immune Response Vaccination Vaccine Trials 40