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.

Vaccine 52

Vaccine Virus Immune Response Disease 52

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.

Vaccine 52

Vaccine Clinical Trials Trials FDA 52

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).

Vaccine 52

Vaccine Trials FDA Clinical Trials 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.

Vaccine 52

Vaccine Clinical Trials Trials Government 52

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.”

Vaccine 52

Vaccine Virus Doctors Engineering 52

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.

Vaccine 52

Vaccine Virus Clinical Trials Disease 52

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. Further, a “trial should aim to minimize missing data” by distinguishing between discontinuation from the study drug and withdrawal from study assessments.

FDA 40

FDA Clinical Trials Vaccine Trials 40

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. Schleifer , M.D., President and Chief Executive Officer of Regeneron. ” The U.S.

Government 52

Government Hospitals Virus Production 52

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.

Therapies 40

Therapies Science FDA Production 40

Drug Discovery World

AUGUST 1, 2023

As per a definition provided by AstraZeneca: “Once inside, ASOs bind with high specificity to target mRNA or pre-mRNA, inducing its degradation – effectively silencing it – to prevent its translation into a detrimental protein product.

RNA 130

RNA Vaccine Drugs Disease 130

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. The average pass rate of phase I trials went up by 5 percent. In time, they were colloquially referred to as “models of life.”

Engineering 125

Engineering Virus DNA Therapies 125

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.

Trials 52

Trials Long-Term Care Facilities Virus Government 52

Drug Discovery World

SEPTEMBER 16, 2022

In 2021, the Cell and Gene Therapy Catapult estimated that there 168 ongoing clinical trials for advanced therapy medicinal products (ATMPs) taking place – representing 9% of all global trials in the space. In the renal gene therapy field the most exciting research is definitely in the UK. billion in funding. .

Therapies 130

Therapies Clinical Trials Production Trials 130

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.

Vaccine 52

Vaccine Production FDA FDA Approval 52

The Pharma Data

NOVEMBER 20, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. “The Yancopoulos, M.D.,

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

The Pharma Data

NOVEMBER 21, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. .” Yancopoulos , M.D.,

FDA 40

FDA Clinical Trials Hospitals Government 40

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.” Another part of providing research animals with a good life is granting them a good death.

Research 113

Research Engineering Science Disease 113

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. By Walker KT et al.

DNA 52

DNA Engineering RNA Therapies 52

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.

Vaccine 52

Vaccine FDA Government Hospitals 52

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.

Virus 52

Virus Hospitals Vaccine RNA 52

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.

Vaccine 40

Vaccine Trials Pharmaceutical Companies Immune Response 40

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.

Vaccine 52

Vaccine Government Hospitals FDA 52

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.

Packaging 52

Packaging Vaccine Government Hospitals 52

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.

Vaccine 52

Vaccine Government Virus Medical Schools 52

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.

Vaccine 52

Vaccine Virus Immune Response Pharmaceutical Companies 52

The Pharma Data

AUGUST 24, 2020

The technique uses antibody-rich blood plasma from people who’ve recovered from the disease and has already been applied to 70,000 people in the US – in trials or for the gravely ill. The FDA says initial trials indicate it is safe, although more are needed to prove effectiveness.

Treatment 52

Treatment FDA Vaccine Virus 52