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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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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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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DrugBank

JULY 18, 2024

Vaccines have consistently demonstrated their efficacy in protecting people from infectious diseases. Yet, the recent COVID-19 pandemic highlighted the obstacles that are inherent today in the development of vaccines. Stabilizers play a crucial role in maintaining the vaccine's potency and integrity throughout its shelf life.

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DrugBaron

JANUARY 2, 2021

Over the past week a furious debate has broken out over the merits of delaying the second dose of the approved COVID vaccines, to increase the number of people who can be given a single dose. The case against doing so is clear: the labels of the approved vaccines are unambiguous that two doses should be given within a certain time window.

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Drugs.com

SEPTEMBER 27, 2023

27, 2023 -- Just 23% of American adults say they 'definitely' will get the new COVID-19 vaccine, while another 23% say they will 'probably' get it, according to a new poll, which also finds interest in the shot falls along partisan. WEDNESDAY, Sept.

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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

JANUARY 11, 2021

adults report being “very likely” or “somewhat likely” to get the COVID-19 vaccine, according to a study published online Jan. adults to assess COVID-19 vaccine hesitancy. MONDAY, Jan. 11, 2021 — More than three-quarters of U.S. 3 in the Journal of Community Health. Jagdish Khubchandani, M.B.B.S.,

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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 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

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 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

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

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

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 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

DECEMBER 3, 2023

The Final Guidance clarifies that, although both applicable drugs and selected drugs must be covered under a Discount Program agreement, selected drugs are excluded from the definition of an applicable drug, so they are not subject to applicable discounts during an MFP applicability year. covered insulin product or vaccine).

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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

MAY 13, 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

MAY 12, 2021

I’m definitely loving the information. could definitely be one of the best in its niche. They are really convincing and will definitely work. You can definitely see your expertise in the article. I will make sure to bookmark it and return to read more of your useful info. Thank you for the post. I will certainly return.

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The Pharma Data

MAY 16, 2021

“If you’re female and truly want to maximize your muscle and ripthe fat off your body, Iron Dolls is definitely a must-have book. Muscle definition doesn’t just appear magically. I highly recommend this ebook for anyone that is looking to increase muscle definition and live a healthy lifestyle. www.IvanNikolov.com.

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LifeSciVC

JANUARY 25, 2024

Having just returned from JP Morgan 2024, I can honestly say that I felt and experienced a definite sense of optimism after three brutal years in biotech. One lab was focused on how bacterial surface carbohydrates activate T-regulatory cells and the other on the development of vaccines against bacterial pathogens.

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The Pharma Data

MAY 16, 2021

My legs are definitely straighter, my posture is better, and I have more muscle definition. Jessica Swinton – Edinburgh, Scotland. ?Wow! I bought Bow Legs No More only 4 months ago and the results have been amazing!

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The Pharma Data

MAY 16, 2021

My legs are definitely straighter, my posture is better, and I have more muscle definition. Jessica Swinton – Edinburgh, Scotland. I bought Knocked Knees No More only 4 months ago and the results have been amazing!

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Agency IQ

MAY 31, 2024

For this reason, the guidance advises sponsors that “some technologies that industry and FDA have historically considered to be platform technologies might not meet the statutory definition and statutory eligibility factors and, if not, would not be eligible for the designation program.”

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The Pharma Data

JUNE 27, 2025

The release of this report marks a significant milestone, but it also underscores the continuing challenges in uncovering definitive answers. The panel stressed that limited access to critical datasets from Chinese authorities has made it impossible to conduct a definitive evaluation of any theory.

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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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The Pharma Data

MAY 13, 2021

With the Customized Fat Loss program there are no supplements required and there is definitely nothing to do with silly exercise gizmos, pills, powders, potions or anything of that nature whatsoever.

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Agency IQ

JULY 22, 2024

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. While the definition of NME has changed over the years, it can sometimes include a combination product consisting of at least one drug that has previously been approved.

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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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