The Pharma Data

JULY 28, 2021

Safety profiles of Vaxzevria, and the mRNA-based vaccine were similar and overall favourable. Very rare clotting disorders (TTS) were observed with both vaccines but these were in line with what would be expected in the general population and lower than in those diagnosed with COVID-19.

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The Pharma Data

JANUARY 15, 2021

15, 2021 (American Heart Association News) — Experts have a simple answer for heart and stroke patients questioning whether they need a COVID-19 vaccination. The Food and Drug Administration-approved vaccines pose no special problems for such patients, said Elkind, who also is president of the American Heart Association.

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The Pharma Data

DECEMBER 18, 2020

Food and Drug Administration said Thursday night that it will move quickly to authorize the emergency use of Moderna’s coronavirus vaccine after one of its advisory panels voted to give its blessing to the shot. “Following today’s positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the U.S.

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The Pharma Data

DECEMBER 10, 2020

–( BUSINESS WIRE )– ImmunityBio , a privately-held immunotherapy company, today announced its COVID-19 vaccine candidate protected nasal and lung airways of non-human primates against coronavirus (SARS-CoV-2) in a challenge study. 11, 2020 02:48 UTC. CULVER CITY, Calif.–( This press release features multimedia.

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The Pharma Data

DECEMBER 21, 2020

experts announced Sunday which Americans will be next in line receive a COVID-19 vaccine, health officials worldwide worried about a new strain of coronavirus that appears to spread faster than before. The two latest groups in line for a vaccine number roughly 50 million. The new COVID-19 vaccines target that spiky protein.

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The Pharma Data

JUNE 24, 2021

This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group. COMIRNATY was the first COVID-19 vaccine to receive authorization in the EU and is the first to have its CMA extended to adolescents. g doses of the COVID-19 vaccine.

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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. 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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The Pharma Data

DECEMBER 22, 2020

None of the newborns of the 127 pregnant women, including 64 who had varying levels of illness from the virus, tested positive for the coronavirus. The study also included 63 pregnant women who tested negative for the virus and 11 reproductive-age women who were not pregnant, to provide comparison.

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The Pharma Data

JULY 28, 2021

The analysis was conducted using AstraZeneca’s global safety database, which captures all spontaneously reported adverse events from real-world use of its medicines and vaccines worldwide. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

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The Pharma Data

DECEMBER 31, 2020

31, 2020 — A new and more infectious variant of the COVID-19 virus has shown up in separate cases in Colorado and California, weeks after it first emerged in the United Kingdom. It also appears that COVID-19 vaccines should protect against it. “And I’m not at all worried it’s going to escape the vaccine.”

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Codon

SEPTEMBER 29, 2024

” The definition was nebulous, but there were agreed-upon themes. Given the fuzziness of the definition, it was unclear which of the released projects deserved the name. On the surface, they hadn't deviated much from the early 2020s: a virus infected a cell and released the genetic therapy hidden within.

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The Pharma Data

DECEMBER 31, 2020

But painstaking work by Australian researchers has revealed that people infected with the SARS-CoV-2 virus have immune memory to protect against reinfection for at least eight months. The possibility remains that people might need regular COVID-19 vaccine shots, just as there are annual flu shots.

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The Pharma Data

JANUARY 8, 2021

announced Thursday that early testing shows its vaccine does still work against the more infectious variants of SARS-CoV-2 first found in Britain and South Africa, Reuters reported. vaccine rollout plagued by delays, Dr. Anthony Fauci urged Americans to be patient on Thursday. There was a glimmer of good news, however: Pfizer Inc.

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PLOS: DNA Science

SEPTEMBER 7, 2023

I could imagine it spitting out definitions, but a textbook is much more than “content.” It earns an A+ in returning definitions of obscure technical terms, like tetrachromacy (enhanced color vision from a fourth type of cone cell) and chromothripsis (shattered chromosomes). ” That definition covers all bases.

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The Pharma Data

DECEMBER 23, 2020

scientists and public health experts, it was announced that there was a growing new strain of the SARS-CoV-2 virus that causes COVID-19. Researchers say, however, they have never seen a virus acquire more than a dozen mutations at once. It may take months to get definitive answers. A New Strain of SARS-CoV-2 ID’ed in UK.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2).

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The Pharma Data

JUNE 25, 2021

AstraZeneca today announced results from the STORM CHASER trial assessing the safety and efficacy of AZD7442, a long-acting antibody (LAAB) combination, for the prevention of symptomatic COVID-19 in participants recently exposed to the SARS-CoV-2 virus. The PROVENT trial will give us more clarity in this patient population.

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The Pharma Data

JANUARY 29, 2021

January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints.

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Agency IQ

JANUARY 19, 2024

Though some biological products may be developed using PCCs, such as viral vaccines, these cultures are also commonly used for in vitro experiments that seek to mimic in vivo conditions as closely as possible (e.g., for renal function studies ). Secondly, their use minimizes both the risk and the impact of viral contamination.

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The Pharma Data

OCTOBER 22, 2020

The Emergency Committee reviewed the data on wild poliovirus (WPV1) and circulating vaccine derived polioviruses (cVDPV). Vaccine derived poliovirus (VDPV). . The same virus has also been detected in sewage in Cairo, Egypt but with no evidence of local circulation. Vaccine management and supply has been significantly impacted.

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The Pharma Data

APRIL 27, 2021

at CER driven by growth drivers Dupixent ® and Vaccines. Vaccines up 5.3%, driven by PPH franchise and demand for influenza vaccines in southern hemisphere. Vaccines delivered growth in its core segments. Business net income is a non-GAAP financial measure (definition in Appendix 7). Influenza vaccines (incl.

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The Pharma Data

NOVEMBER 20, 2020

“The casirivimab and imdevimab antibody cocktail is designed to mimic what a well-functioning immune system does by using very potent antibodies to neutralize the virus,” said George D. Definition of High-Risk Patients. Yancopoulos, M.D., President and Chief Scientific Officer of Regeneron. Have chronic kidney disease.

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The Pharma Data

JANUARY 12, 2021

“Tackling the COVID-19 pandemic will require a combination of public health measures, vaccines and therapeutics. “Additionally, as expected, the virus continues to mutate, with the possibility of developing resistance to any one antibody. . Definition of High-Risk Patients. Schleifer , M.D., ” The U.S.

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The Pharma Data

MAY 15, 2021

In fact, he believes that the virus that causes it has died out completely. You’re possibly aware that shingles are caused by the varicella-zoster virus. The varicella-zoster virus has been with you since you got rid of that illness – which was possible decades ago. However, the virus still lies dormant in our nerve cells.

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Agency IQ

DECEMBER 1, 2023

It also stated that companies should consider whether an investigational product might interact with an administered vaccine for Covid-19. Regarding vaccination status: The new document expands upon a previously simple recommendation to determine vaccination status for patients enrolled in clinical trials.

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The Pharma Data

NOVEMBER 21, 2020

.” “REGEN-COV2 is designed to mimic what a well-functioning immune system does by using very potent antibodies to neutralize the virus,” said George D. Definition of High-Risk Patients. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron. Have chronic kidney disease. Have diabetes.

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Agency IQ

NOVEMBER 3, 2023

Unfortunately, there is no regulatory body that governs the terminology used in this space, although there are definitions that are generally accepted by the scientific community. Postbiotic: “Preparation of inanimate micro-organisms and/or their components that confers a health benefit on the host,” according to the ISAPP definition.

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Codon

JULY 21, 2024

As the biotechnologist Alex Telford writes , “Without mouse models, we may never have developed polio and meningitis vaccines, organ transplants, GLP-1 drugs, gene therapies , or any other number of transformative treatments.” It follows that Esvelt’s lab aims to couple these traits.

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Codon

MARCH 12, 2023

Base editor proteins were delivered into the mice using a virus, called AAV9. coli genes into a piece of simian virus DNA. The landmark paper enabled revolutions in insulin biomanufacturing, CAR-T therapies, and the bioproduction of most modern vaccines; in other words, much of what we take for granted today.

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Agency IQ

NOVEMBER 3, 2023

A 2017 European Parliament resolution called on the European Commission and the European Council “to formulate a better definition of the concept – and analyse the causes – of shortages of medicines.” BY KIRSTEN MESSMER, PHD, RAC | OCT 27, 2023 8:03 PM CDT Background on E.U.

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The Pharma Data

DECEMBER 22, 2020

Seeking to reassure a troubled nation, President-Elect Joe Biden received the first dose of the two-dose Pfizer COVID-19 vaccine on Monday. Biden said, “I’m doing this to demonstrate that people should be prepared when it’s available to take the vaccine,” the New York Times reported. The sequencing in the U.S.

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PLOS: DNA Science

FEBRUARY 20, 2025

With infectious diseases on the rise, she asked me to repost CDC’s Adult Vaccine Assessment Tool. could head Health and Human Services, and friends asking me which vaccines they needed to update or get for the first time. Which Vaccines Require Boosters? But which other vaccines should my daughter and her cohort get?

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The Pharma Data

DECEMBER 23, 2020

and the Trump Administration were close to a deal on Tuesday that would get more of the company’s coronavirus vaccine to Americans in the coming year. So far, only two pharmaceutical companies — Pfizer and Moderna — have won emergency approval for their COVID-19 vaccines. WEDNESDAY, Dec.

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The Pharma Data

JANUARY 7, 2021

“Here at the CDC, we’re definitely taking this seriously, and we’re assuming for now that this variant is more transmissible,” said Greg Armstrong, the leader of the CDC’s strain surveillance program. .” Herd immunity will be reached when the virus encounters enough people with immunity that it dies out.

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The Pharma Data

AUGUST 24, 2020

The top US virus expert has warned against rushing out a Covid-19 vaccine before it has been proven to be safe and effective. Speaking to Reuters news agency, Dr Anthony Fauci also said doing so could hurt the development of other vaccines. Oxford coronavirus vaccine triggers immune response.

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The Pharma Data

AUGUST 24, 2020

“I’m pleased to make a truly historic announcement in our battle against the China virus that will save countless lives.” In a tweet on Saturday, President Trump said “the deep state, or whoever, at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics.

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