The Pharma Data

DECEMBER 15, 2020

COVID-19 Death Toll Hits 300,000 as Vaccine Rollout Begins. 15, 2020 — The number of Americans killed by COVID-19 topped 300,000 on Monday, the same day the country launched a massive vaccination campaign to curb the spread of COVID-19. KFF COVID-19 Vaccine Monitor. Professional. TUESDAY, Dec. The Washington Post Article.

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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 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

DECEMBER 19, 2020

19, 2020 (Healthday News) — Moderna’s coronavirus vaccine was granted emergency use approval by the U.S. Food and Drug Administration on Friday, and it will now join Pfizer’s vaccine in an unprecedented national campaign to inoculate enough Americans to stem the spread of COVID-19. SATURDAY, Dec.

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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 15, 2020

15, 2020 (Healthday News) — The number of Americans killed by the new coronavirus topped 300,000 on Monday, the same day the country launched a massive vaccination campaign to curb the spread of COVID-19. TUESDAY, Dec. And on Tuesday morning, scientists from the U.S. Kaiser polled 1,676 adults for the survey.

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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

APRIL 1, 2021

vaccine efficacy observed against COVID-19, measured seven days through up to six months after the second dose. Vaccine was 100% effective in preventing severe disease as defined by the U.S. Vaccine was 100% effective in preventing COVID-19 cases in South Africa, where the B.1.351 Food and Drug Administration.

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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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PLOS: DNA Science

OCTOBER 3, 2024

One of the oldest and most successful immunotherapies is simpler: a tamed version of a classic vaccine, against the infectious disease tuberculosis (TB). “BCG” is the “treatment” vaccine’s technical name, for Mycobacterium bovis Bacillus Calmette-Guérin. The approach worked.

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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

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

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

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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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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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 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.–(

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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

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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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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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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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

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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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

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

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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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

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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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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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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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

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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