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. 12, 2020 – The U.S.

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Codon

AUGUST 26, 2024

He also explains how they could be used to combat pandemics on “day zero,” well before vaccines are developed. After the outbreak ended, it took another three years for the first Ebola vaccine by Merck to be approved. Timelines for vaccine development are shrinking, but can it move even faster?

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The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants.

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The Pharma Data

MAY 26, 2023

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19 Pfizer Inc. 1) “Great advancements have been made in the fight against COVID-19, yet the virus remains a present and unpredictable concern. NYSE: PFE) announced today that the U.S. More than 11.6

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The Pharma Data

FEBRUARY 23, 2022

* Final analysis of the global VAT02 booster trial confirms universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus). * efficacy against any symptomatic COVID-19 disease, in line with expected vaccine effectiveness in today’s environment dominated by variants of concern.

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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. under an Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. We are pleased to work with U.S. AUTHORIZED USE IN THE U.S.:

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The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been recommended for conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

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The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

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PerkinElmer

AUGUST 13, 2020

The virus, which can cause a severe form of pneumonia and lead to acute respiratory distress, currently has no FDA-approved targeted therapeutic or vaccine. For this reason, researchers around the globe are scrambling to understand this novel virus and figure out its potentially targetable vulnerabilities.

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The Pharma Data

NOVEMBER 18, 2020

The simple nasal swab test, developed by Lucira Health, requires a prescription and people under the age of 14 can’t perform the test on themselves, the FDA said in a statement. The California company said that clinical trials showed 100% of patients were able to perform the Lucira test in about two minutes.

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The Pharma Data

NOVEMBER 9, 2020

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. GAITHERSBURG, Md., Glenn, M.D., and globally.”.

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The Pharma Data

AUGUST 16, 2021

Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of the companies’ COVID-19 vaccine (BNT162b2) for future licensure. The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule.

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The Pharma Data

JANUARY 6, 2021

6 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted emergency use authorisation in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunisation of adults. Additional safety and efficacy data will continue to accumulate from ongoing clinical trials.

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The Pharma Data

DECEMBER 16, 2020

Food and Drug Administration (FDA) advisory panel in regard to the COVID-19 vaccine from Moderna. The Vaccines and Related Biological Products Advisory Committee will be determining whether the product should be authorized for emergency use, according to CNBC. The vote itself is not slated to take place until after 3 p.m.

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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.–( This press release features multimedia.

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Vial

DECEMBER 11, 2023

Hepatitis C virus (HCV) infection is a global health problem with complications that place a significant economic burden on national health systems. The Food and Drug Administration (FDA) approved and recommended dozens of small-molecule drugs. Genetic diversity of HCV is also a significant challenge in HGC vaccine development.

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The Pharma Data

NOVEMBER 30, 2020

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. pivotal Phase 3 trial update. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K.

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The Pharma Data

DECEMBER 3, 2020

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. No serious adverse events related to the vaccine candidates studied were reported.

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The Pharma Data

MAY 13, 2021

CDC Advisers Endorse Pfizer Vaccine for Children Ages 12 to 15 ( NYTimes ) ( Reuters ) ( STAT ). US CDC finds more clotting cases after J&J vaccine, sees causal link ( Reuters ) ( NBC ) ( NYTimes ). Covid vaccines may not protect people with immune disorders. NIH trial seeks answers. (

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EG Life Sciences

FEBRUARY 15, 2023

It is without a doubt that 2022 predicted change and opportunity in biopharma and biotech clinical trials in 2023. The US Food and Drug Administration (FDA) approved around 26 novel drugs in 2022. Approval processes were slow in comparison to 2020 and 2021, where 53 and 50 approvals were achieved respectively.

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The Pharma Data

DECEMBER 10, 2020

. Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose. Jansen, Ph.D.,

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The Pharma Data

NOVEMBER 23, 2021

Approval is for Cytomegalovirus, a Type of Herpes Virus. Livtencity works by preventing the activity of human cytomegalovirus enzyme pUL97, thus blocking virus replication. director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. The FDA, an agency within theU.S.

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The Pharma Data

DECEMBER 18, 2020

Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. Hahn , M.D.

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The Pharma Data

SEPTEMBER 11, 2020

60,000 people across Britain may have been suffering from prolonged symptoms of coronavirus months after contracting the virus. Chinese drug firm says thousands have been vaccinated for COVID-19 on an emergency use scheme. AstraZeneca slams brakes on COVID-19 vaccine trial over unexplained participant illness.

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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. Who is first in line? Centers for Disease Control and Prevention.

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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

FEBRUARY 23, 2022

Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend Pfizer’s TicoVac TM (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older, in the following U.S. Global President, Vaccines, Pfizer. “We

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The Pharma Data

DECEMBER 11, 2020

FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021.

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The Pharma Data

NOVEMBER 16, 2020

The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. The majority of adverse events were mild or moderate in severity.

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NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

A leader in this critical effort is NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV ) initiative, a public-private partnership involving 20 biopharmaceutical companies, academic experts, and multiple federal agencies. Vaccines Working Group : Accelerates the evaluation of vaccine candidates.

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Agency IQ

DECEMBER 1, 2023

FDA’s guidance on developing products to prevent or treat Covid-19 Of the five guidance documents that received an extension, one addresses the development of drugs and biological products for Covid-19. It also stated that companies should consider whether an investigational product might interact with an administered vaccine for Covid-19.

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The Pharma Data

NOVEMBER 17, 2021

For the past year and a half, the COVID-19 pandemic has continued to engulf the globe, fueled in part by novel variants and the uneven distribution of vaccines. If disulfiram’s effect against SARS-CoV-2 is confirmed, it could become a useful tool against the virus. A Pandemic Pivot. It’s a work in progress,” Sander said.

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Codon

MAY 18, 2023

link ) An mRNA vaccine for many types of flu viruses is now in a phase I clinical trial. No more designing new flu vaccines each year? Scientists removed Ashanti’s blood cells and inserted a functional copy of the ADA gene via a virus. ” The clinical trial was halted and 69 others were investigated.

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Codon

MAY 18, 2023

link ) An mRNA vaccine for many types of flu viruses is now in a phase I clinical trial. No more designing new flu vaccines each year? Scientists removed Ashanti’s blood cells and inserted a functional copy of the ADA gene via a virus. ” The clinical trial was halted and 69 others were investigated.

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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.

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The Pharma Data

SEPTEMBER 1, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE:BMY) today announced interim results from the Phase 3 open-label extension trial DAYBREAK, demonstrating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with relapsing forms of multiple sclerosis (MS). of participants in the trial, respectively.

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The Pharma Data

APRIL 6, 2021

OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Malignancy, and Thrombosis. Viral Reactivation – Viral reactivation, including cases of herpes virus reactivation (e.g., See the full Prescribing Information here.

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