XTalks

SEPTEMBER 29, 2021

US President Joe Biden rolled up his sleeve yesterday for the third time this year to receive a Pfizer vaccine booster shot. However, the CDC went against ACIP’s advice and backed third doses for all frontline workers and those with high-risk institutional exposures.

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Pfizer

JULY 8, 2022

Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®. Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®. Fri, 07/08/2022 - 09:45. Friday, July 08, 2022 - 11:00am.

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pharmaphorum

NOVEMBER 18, 2020

Pfizer is preparing to file its COVID-19 vaccine after a trial reached the safety milestone required by US regulators for emergency use, according to press reports. However the company has already said it would have the two months of safety data required by the FDA by the third week of November.

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Pfizer

SEPTEMBER 16, 2022

Pfizer and BioNTech Receive Positive CHMP Opinion for Conversion of COMIRNATY® Conditional Marketing Authorization to Full Marketing Authorization in the European Union. Standard marketing authorization recommendation applies to all indications and formulations in the European Union, including COMIRNATY® Original/Omicron BA.4-5

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FDA Law Blog

SEPTEMBER 10, 2023

Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program.

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XTalks

JULY 26, 2021

The Centers for Disease Control and Prevention (CDC) has endorsed the J&J/Janssen COVID-19 vaccine, stating that the benefits of the vaccine still outweigh any potential risks. million administered vaccine doses have been reported among those who received the J&J COVID-19 vaccine.

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XTalks

DECEMBER 17, 2021

Xtalks is taking a look at some of the major stories and innovations of the year in the life sciences, many of which were driven by new, emerging and improved technologies. The year continued to be dominated by COVID-19, and the second year of the pandemic was all about vaccines. COVID-19: The Pandemic and the Vaccines.

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Pfizer

FEBRUARY 16, 2023

who had been enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) Phase 3 clinical study. The study is investigating the efficacy, safety and immunogenicity of an investigational Lyme disease vaccine candidate, VLA15.

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The Pharma Data

DECEMBER 12, 2020

Food and Drug Administration approved Pfizer’s coronavirus vaccine for emergency use on Friday, clearing the way for the launch of a national campaign to inoculate enough Americans to stem the spread of COVID-19. ” Who is first in line to be vaccinated? .” SATURDAY, Dec.

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Eye on FDA

SEPTEMBER 2, 2020

Since last week’s posting regarding FDA credibility being on the line, there has been a swirl of activity and commentary around the evaluation of vaccine research for COVID-19 that would seem to have exacerbated the problem. Second, he also apologized for the characterization. That is a lot to unpack.

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Eye on FDA

MARCH 30, 2022

Tectonic pandemic plates are shifting respecting the COVID-19 pandemic. First, government funding supporting access to vaccination and treatment for COVID has run out and so far, is not replenished. Third, the BA.2 For weeks now we have been watching caseloads in the United States broadly fall. 2 wave in the U.S.

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pharmaphorum

OCTOBER 5, 2021

The EMA has given the go-ahead to the use of Pfizer and BioNTech’s COVID-19 vaccine Comirnaty as a booster for all people aged 18 or more, but says EU member states must decide for themselves whether to make a third dose available to their citizens. More evidence of waning immunity?

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XTalks

DECEMBER 7, 2020

Past Few Weeks Herald Good News on the Vaccine Front. First came the news from Pfizer and its German partner BioNTech that their mRNA vaccine was 90 percent effective in preventing symptomatic COVID-19 disease. No hospitalizations or severe cases of COVID-19 were reported among those receiving the AZD1222 vaccine either.

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The Pharma Data

DECEMBER 3, 2020

The Pfizer – BioNTech and Moderna ’s COVID-19 vaccines are currently being reviewed for possible Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA). The downgrade of this year’s 100-million-dose goal to 50 million was caused by supply-chain issues.

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XTalks

DECEMBER 24, 2020

The year 2020 is certainly one that will go down in the books, thanks — or rather, no thanks — to the COVID-19 pandemic. For example, investment in mRNA vaccines and viral vectors came well before January, many years before it. COVID-19: The Pandemic Timeline and Journey. Here is a review of what 2020 served up.

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The Pharma Data

DECEMBER 11, 2020

Food and Drug Administration is expected to approve emergency use of Pfizer’s coronavirus vaccine as early as Saturday after its advisory panel cleared the way for the start of a national campaign to inoculate Americans and stem the spread of COVID-19. The emergency approval comes not a moment too soon.

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The Pharma Data

DECEMBER 23, 2020

We are now in the 50th week of the Covid-19 pandemic and the situation worldwide shows that there have been 75,479,471 confirmed cases and 1,686,267 deaths, according to the World Health Organisation. A watershed moment for Pfizer and BioNTech as they announced Covid-19 vaccine was 90 per cent efficient.

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Delveinsight

DECEMBER 15, 2020

Gannex received US FDA fast track designation for its NASH drug, ASC42 an FXR Agonist. Gannex Pharma has received Fast Track designation approval from FDA for its drug candidate ASC42 for non-alcoholic steatohepatitis (NASH). Sold under the name Jakafi, it is FDA-approved for the treatment of polycythemia vera (PV) in adults.

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XTalks

AUGUST 2, 2023

With each passing year, pharmaceutical companies around the globe strive to deliver cutting-edge medicines, therapies and vaccines that impact the lives of millions. Note: When it comes to companies that report in foreign currencies, the conversion to US dollars utilizes the average annual exchange rates reported by the US Federal Reserve.

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The Pharma Data

FEBRUARY 1, 2021

HOUSTON, TX, February 01, 2021 /24-7PressRelease/ — It has been just over a year since the COVID-19 virus arrived in the United States, already claiming the lives of over 400,000 Americans. Medical professionals are desperately seeking effective treatments as hospitals are continuously overwhelmed with COVID-19 patients.

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XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. Tension is mounting as nations big and small jockey around industry to ensure they are first in line to access a vaccine, should one prove to be successful against COVID-19. Moderna’s COVID-19 Vaccine.

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The Pharma Data

JANUARY 4, 2021

HOUSTON, TX, January 04, 2021 /24-7PressRelease/ — Around the country and especially in Texas, positive COVID-19 cases continue to break records seemingly every day. Other blood centers in California, the state which currently has the highest number of COVID-19 infections in the country, are battling a similar issue.

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The Pharma Data

JANUARY 12, 2021

Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization. New agreement covers 1.25 supply to over 1.5 million doses.

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The Pharma Data

DECEMBER 20, 2020

Food and Drug Administration (FDA) is plenty busy with COVID-19 vaccine Emergency Use Authorizations (EUAs) this month, but they’re also wrapping up the year with a few PDUFA dates for other therapies. The FDA completed a class 2 response in July 2020. Here’s a look.

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Pharmaceutical Technology

NOVEMBER 15, 2022

Two weeks ago, the US Centers for Disease Control and Prevention (CDC) director Rochelle Walensky became the latest high-profile individual to report a case of Paxlovid rebound. Similar cases have been in the news for several months as the antiviral’s use increases, but the cause of such effects has remained mostly unknown.

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pharmaphorum

OCTOBER 21, 2021

The FDA has authorised booster shots with Moderna and Johnson & Johnson’s COVID-19 vaccines, a month after giving the go-ahead to a third-dose of Pfizer/BioNTech’s shot. S vaccine, which is initially administered as one rather than two doses. The FDA has followed that advice.

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pharmaphorum

FEBRUARY 28, 2021

The FDA has approved emergency use of a third COVID-19 vaccine from Johnson & Johnson’s Janssen Biotech unit, the day after an advisory committee concluded it was safe and effective. The EUA allows the vaccine to be distributed in the U.S for use in individuals 18 years and older.

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The Pharma Data

NOVEMBER 20, 2020

(NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19 , has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

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The Pharma Data

NOVEMBER 21, 2020

Authorized for recently diagnosed, mild to moderate COVID-19 in high-risk patients. Food and Drug Administration (FDA). “The science and technology investments Regeneron has made over three decades positioned us to move rapidly to invent, study and maximize production of REGEN-COV2. TARRYTOWN, N.Y. ,

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pharmaphorum

JANUARY 9, 2023

Forecasters use terms like “unprecedented,” “inflection point,” and “transformative” when in forward-facing Janus mode. In some ways, it is not difficult to understand why: healthcare faced unprecedented challenge from the COVID-19 pandemic and responded in an extraordinary way. Things fall apart: deglobalisation.

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Druggist

SEPTEMBER 2, 2021

Amidst the second wave of covid-19 , Ivermectin was a vital part of health discussions conducted by professionals. Post analysis, the evaluation resulted in favor of Ivermectin; many states have already included this drug in the covid kit. Ivermectin was discovered in 1975, which was launched officially for medical use in 1981.

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Druggist

SEPTEMBER 2, 2021

Amidst the second wave of covid-19, Ivermectin was a vital part of health discussions conducted by professionals. Post analysis, the evaluation resulted in favor of Ivermectin; many states have already included this drug in the covid kit. Ivermectin was discovered in 1975, which was launched officially for medical use in 1981.

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The Pharma Data

MAY 4, 2021

to $3.65, Primarily Reflecting Updates to Anticipated Contributions from BNT162b2 Partially Offset by Additional R&D Expenses for Vaccines to Protect Against COVID-19 as Well as Other mRNA-Based Development Programs and COVID-19 Antivirals. First-Quarter 2021 Revenues of $14.6 EXECUTIVE COMMENTARY.

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The Pharma Data

FEBRUARY 24, 2022

The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on a variation to the Conditional Marketing Authorization in the near future. The COVID-19 vaccine booster for individuals 12 through 15 years of age was already granted Emergency Use Authorization by the U.S.

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Eye on FDA

AUGUST 24, 2020

In normal times, when there is no pandemic threatening our lives and livelihoods, it is essential for FDA to maintain the traditional “gold standard” in relation to the decision-making process for the approval of new treatments.

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The Pharma Data

NOVEMBER 30, 2020

On November 20, Pfizer and BioNTech submitted an application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for their COVID-19 vaccine. government’s Operation Warp Speed, have indicated they will begin distribution within 24 hours of authorization.

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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. MONDAY, Dec. In the United States, New York Gov.

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