The Pharma Data

JANUARY 6, 2021

Two-Thirds of Lupus Patients Likely to Take COVID-19 Vaccine. 6, 2021 — Two-thirds of people with lupus are willing to receive a COVID-19 vaccine, according to the results of a survey released by the Lupus Research Alliance. Hispanic respondents are most likely (34 percent) to say they are undecided about taking the vaccine.

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The Pharma Data

OCTOBER 21, 2020

Fauci ‘Cautiously Optimistic’ for COVID-19 Vaccine by Year’s End. the leading infectious disease expert in the United States, said on Wednesday he is “cautiously optimistic” that a COVID-19 vaccine will be ready by year’s end. Multiple studies are testing three vaccine approaches, Fauci said.

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The Pharma Data

JANUARY 29, 2021

Adults Want the COVID-19 Vaccine as Soon as Possible. adults are increasingly eager to get the COVID-19 vaccine, according to survey results released by the Kaiser Family Foundation (KFF) COVID-19 Vaccine Monitor. “It provides hope that vaccine confidence will build over time.” Professional. FRIDAY, Jan.

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The Pharma Data

SEPTEMBER 23, 2020

The halting of AstraZeneca’s COVID-19 vaccine trial around the world was cause for much initial concern over the eventual safety and efficacy of the therapy. Eventually, it’s the public who will either take this vaccine or not, so it is to their advantage to be transparent as possible.”. Matt Fellows. Source link.

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The Pharma Data

NOVEMBER 22, 2020

As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. The combined analysis showed average efficacy of 70%.

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The Pharma Data

JANUARY 11, 2021

health officials raced to ramp up the delivery of COVID-19 vaccines across the country as both coronavirus case counts and death tallies continued to hit record highs. “We really need to get this vaccine out more quickly, because this is really our only tool,” Dr. Scott Gottlieb, former commissioner of the U.S. .

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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

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

AUGUST 3, 2021

Accelerates development of current Sanofi licensed programs in vaccines and potential to explore other therapeutic areas Fast tracks establishment of Sanofi’s recently announced mRNA Center of Excellence Full integration upgrades drug formulation capabilities and enhances US talent in a promising new technology.

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FDA Law Blog: Biosimilars

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. What is noteworthy about this proposed definition is that it adds a new requirement that “[a] manufacturer must make data available to CMS to support its finding.”

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Eye on FDA

AUGUST 13, 2021

What does “fully vaccinated” mean today? In the face of the widening spread of the SARS-Cov-2 variant, the rise in breakthrough cases, and data that suggests a slight waning effect over time of vaccines, FDA acted yesterday to protect some of the most vulnerable by amending the Emergency Use Authorization of the mRNA vaccines.

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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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Plenge Gen

MAY 28, 2021

In this blog I define programmable therapeutics and provide a few recent examples (severe combined immune deficiency and mRNA vaccines). As you will see, programmable therapeutics is more than pure imagination – we are seeing this new concept evolve before our very eyes. What is the concept of programmable therapeutics?

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FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease. 1396r-8(k)(3). date of payment, date of shipment, date of invoice, etc.).

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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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The Pharma Data

MAY 31, 2022

billion in potential development milestones Proposed acquisition provides access to next-generation 24-valent pneumococcal vaccine candidate in phase II development and highly innovative, MAPS TM technology Supports development of a strong portfolio of innovative vaccines and specialty medicines. GSK to pay $2.1

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The Pharma Data

JUNE 2, 2022

GSK plc (LSE/NYSE: GSK) announced that it has entered into a definitive agreement to acquire Affinivax, Inc. Affinivax is pioneering the development of a novel class of vaccines, the most advanced of which are next-generation pneumococcal vaccines. billion upfront payment and up to $1.2

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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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NIH Director's Blog: Drug Development

DECEMBER 15, 2020

Indeed, it shows that no matter your current experience with COVID-19, there are opportunities to get involved to develop vaccines and medicines that will help everyone. This registry is creating a list of potential volunteers willing to take part in ongoing or future NIH clinical trials focused on preventing COVID-19—like vaccines.

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The Pharma Data

DECEMBER 31, 2020

Doctors on the pandemic’s front line say people shouldn’t panic, but should definitely adhere even more closely to proven infection control measures, like mask wearing and social distancing. It also appears that COVID-19 vaccines should protect against it. THURSDAY, Dec. Centers for Disease Control and Prevention.

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The Pharma Data

APRIL 7, 2022

announced today that the companies have entered into a definitive agreement under which Pfizer will acquire ReViral, a privately held, clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel antiviral therapeutics that target respiratory syncytial virus (RSV). “At Pfizer Inc.

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Drug Channels

FEBRUARY 22, 2022

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. The 2022 Economic Report on U.S.

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The Pharma Data

DECEMBER 22, 2020

While finding lower-than-expected levels of protective antibodies in umbilical cord blood, researchers found high levels of influenza antibodies, possibly from maternal flu vaccination, according to the study. “I think it’s a really exciting time. I think we now have the tools to end this pandemic.

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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 31, 2020

This discovery indicates that COVID-19 vaccines will create lasting immunity, said senior researcher Menno van Zelm. The possibility remains that people might need regular COVID-19 vaccine shots, just as there are annual flu shots. ” © 2020 HealthDay. All rights reserved. Posted: December 2020. Source link.

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Eye on FDA

FEBRUARY 22, 2022

Communications regarding aspects of agency work vis a vis the pandemic fell in 2021 compared to the year before, despite the number of developments in vaccines and therapeutics during the year. The overall trend is definitely downward. Not only was the agency saying less, it was saying less about COVID. Why is this important?

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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

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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The Pharma Data

NOVEMBER 10, 2020

million using the broader CDC increased-risk definition. “Policy makers seeking to make efficient and equitable decisions about reopening the economy and about vaccine distribution should consider the health risks not only of workers, but also of those with whom they live,” the authors write.

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Eye on FDA

APRIL 22, 2020

There are many scenarios of what may happen with the COVID-19 pandemic, but one of them is that the recovery is represented less by a definite demarcation – a turning point or represented by straight lines – to one represented by wavy lines, where infection rates go up and down. And all that happened nearly forty years ago.

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The Pharma Data

OCTOBER 6, 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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Agency IQ

JULY 12, 2024

The up-front glossary in the new guidance also provides standard definitions related to a product’s approved use, an “unapproved use” (i.e., statins cause earlobe enlargement”)” – or, perhaps more realistically, misinformation on the internet about vaccines. something not in the labeling), labeling and medical product.

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The Pharma Data

JUNE 26, 2021

All current COVID-19 vaccines and antibody-based therapeutics were designed to disrupt this route into cells, which requires a receptor called ACE2. The ability to use an alternative entry pathway opens up the possibility of evading COVID-19 antibodies or vaccines, but the researchers did not find evidence of such evasion. and Edith L.

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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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The ChEMBL-og

APRIL 16, 2024

The definition of a chemical probe has been amended to update the field MOLECULE_DICTIONARY.CHEMICAL_PROBE. 71 out of the 882 newly added EMA drugs are only authorised by EMA, rather than from other regulatory bodies e.g. FDA.

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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

OCTOBER 22, 2020

The Emergency Committee reviewed the data on wild poliovirus (WPV1) and circulating vaccine derived polioviruses (cVDPV). Vaccine derived poliovirus (VDPV). . Vaccine management and supply has been significantly impacted. More than 60 campaigns in 28 countries have been postponed since late February and early March.

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