pharmaphorum

AUGUST 12, 2021

The UK government has started ordering COVID-19 vaccines for a 2022 booster campaign, including a 32 million-dose order for the Pfizer/BioNTech shot, even before third doses for 2021 have been given the go-ahead. The Johnson & Johnson vaccine is also supplied on a no-profit basis. Pricing slammed.

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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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Protein Vaccination Vaccine Immune Response 126

pharmaphorum

SEPTEMBER 12, 2022

Pfizer and BioNTech’s COVID-19 vaccine targeting Omicron BA.4 The EMA said the decision by the CHMP will “further extend the arsenal of available vaccines to protect people against COVID-19 as the pandemic continues and new waves of infections are anticipated in the cold season.” 1 strain of the variant.

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pharmaphorum

JULY 26, 2021

The test – originally developed by US manufacturer Chembio Diagnostics – has been introduced into the UK and Irish markets by Guilford-based Luas Diagnostics and tests for the presence of SARS-CoV-2-targeting antibodies in the blood. That’s a question that a fingerprick test launched today in the UK and Ireland could help to answer.

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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

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

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

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

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.

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Vaccination Vaccine Immune Response Trials 52

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

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

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

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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pharmaphorum

JANUARY 27, 2021

The French pharma will use its production infrastructure to boost supplies of the vaccine and perform late-stage manufacturing to supply over 125 million doses to the EU. This is expected to delay availability of the vaccine until later this year. In a statement Sanofi said that the production capacity will be at its Frankfurt plant.

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Vaccination Vaccine Immune Response Manufacturing 69

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

pharmaphorum

JUNE 9, 2021

Pfizer has the FDA approval it was seeking for Prevnar 20, the latest update to its blockbuster pneumococcal vaccination franchise, keeping it one step ahead of a competing shot from Merck & Co. In two phase 3 trials in adults reported last year, V114 stimulated immune responses to all serotypes in the shot.

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Vaccination Vaccine Immune Response Regulation 52

pharmaphorum

JUNE 2, 2021

Capacity to supply Moderna’s COVID-19 vaccine in Europe could be swelled by round 300 million doses a year, following an agreement to set up a new production line at contract manufacturer Lonza. US marketing application. Pfizer and BioNTech filed for FDA approval of their COVID-19 vaccine on 7 May. WHO backs Sinovac shot.

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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

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. The proposed supply agreement with the European Commission would represent the largest initial order of vaccine doses for Pfizer and BioNTech to date. billion doses by the end of 2021.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

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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The Pharma Data

JANUARY 24, 2021

(NYSE: MRK), known as MSD outside the United States and Canada, today announced that the company is discontinuing development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591, and plans to focus its SARS-CoV-2/COVID-19 research strategy and production capabilities on advancing two therapeutic candidates, MK-4482 and MK-7110.

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Development Vaccination Vaccine Production 52

Drug Discovery World

MAY 6, 2024

During the period 2016-2021, the Brazilian, Chinese and Indian markets grew by 11.7%, 6.7% respectively compared to an average market growth of 5.8% for the top five European Union markets and 5.6% for the US market 2. However, Europe is facing increasing competition from emerging economies.

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Drugs Life Science Gene Editing Gene 59

pharmaphorum

MARCH 28, 2022

The US regulator has trimmed back the emergency-use authorisation for Xevudy (sotrovimab), saying that new data suggests the current 500mg dose of the antibody is unlikely to be effective against the BA.2 2, and would be sharing these data with regulators around the world. 2 subvariant of Omicron.

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Antibody Immune Response Regulation Sales 52

Pharmaceutical Technology

JANUARY 19, 2023

The Korean Ministry of Food and Drug Safety (KMFDS) has granted expanded approval to Novavax partner SK bioscience for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use as a booster dose in adults aged 18 and above. Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain.

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Vaccination Vaccine Immune Response Protein 147

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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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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Vaccination Vaccine Containment Clinical Trials 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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Vaccination Vaccine Containment Clinical Trials 52

Roots Analysis

OCTOBER 30, 2023

These RNA based therapeutics play a crucial role in protein production and regulation of gene functions. The next generation RNA therapeutics and RNA vaccines pipeline currently features the presence of more than 20 circular RNA therapeutics and vaccines, being developed across initial stages of drug development (discovery and preclinical).

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RNA Vaccination Vaccine Development 40

Drug Discovery World

APRIL 20, 2023

Symptoms affect the brain, heart, lungs, GI tract and pancreas, are seen equally in vaccinated populations, and sometimes newly emerge after the acute infection has resolved. Given the timescales and resources involved, funders would need convincing that there is a long-term market for a treatment targeting post-Covid-19 cognition.

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Development Drugs Clinical Trials Clinical Trials 98

The Pharma Data

JANUARY 21, 2021

Because the new COVID-19 vaccines should still work on these viral interlopers. Luckily, the new variants still rely on the coronavirus’ “spike protein” to infect cells, and the two COVID vaccines now on the U.S. FRIDAY, Jan. “The spike is really critical. “That process is done so efficiently by the [U.S.

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Vaccination Vaccine Protein Immune Response 52

pharmaphorum

FEBRUARY 28, 2021

The FDA has approved emergency use of a third COVID-19 vaccine from Johnson & Johnson’s Janssen Biotech unit, the day after an advisory committee concluded it was safe and effective. Today, FDA issued an emergency use authorization (EUA) for the third vaccine for the prevention of #COVID19 caused by SARS-CoV-2. Janssen’s Ad26.COV2.S

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Vaccination Vaccine Immune Response Protein 59

Drug Discovery World

MAY 11, 2023

Kerstin Pohl , Senior Global Marketing Manager, Gene Therapy & Nucleic Acid at SCIEX, looks at the application of liquid chromatography-mass spectrometry for analysing host cell proteins. Gene-based therapeutics and vaccines hold immense potential for more efficient and personalised treatment and prevention of complex diseases.

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Production Gene Protein Vaccination 52

pharmaphorum

JULY 9, 2021

With the COVID-19 delta variant has become the dominant strain circulating in the US, Pfizer and BioNTech have said they will ask the FDA and other regulators to approve a third dose of their Comirnaty vaccine to guard against a winter surge in cases. .

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The Pharma Data

OCTOBER 9, 2021

years of exposure 3 Design of a new open-label study assessing immune response to SARS-CoV-2 mRNA vaccines in MS-patients treated with Kesimpta 4 , and new findings from open-label study assessing immune response to SARS-CoV-2 mRNA vaccines in secondary progressive MS (SPMS) patients treated with Mayzent will be presented 5.

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Drug Discovery World

AUGUST 1, 2023

Also from Alnylam, in September 2022, the European Commission (EC) has granted marketing authorisation for the company’s AMVUTTRA (vutrisiran) for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis. Harwell, a science and innovation campus in Oxfordshire, was selected for the location.

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RNA Drugs Gene Silencing Vaccination 52

Pharma Marketing Network

JANUARY 20, 2021

Regarding OWS’s support for vaccine development, Dr Slaoui noted that 5 of the 6 vaccines selected (from a total of 94 programs) are currently in phase 3 development or approved. The response to this crisis has “transformed the vaccine industry.”.

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Vaccination Vaccine In-Vivo Genetics 52

Drug Discovery World

FEBRUARY 15, 2023

Cancer is a complex heterogenous multistep disease characterised by uncontrolled cell proliferation combined with a dysregulated immune response. A healthy immune system is naturally primed to eliminate malignant and abnormal cells through a synchronised and dynamic interplay between adaptive and innate immunity.

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Research In-Vitro In-Vivo Development 52