XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease.

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XTalks

JUNE 5, 2023

Pfizer has announced that its respiratory syncytial virus (RSV) vaccine, Abrysvo, has received approval from the US Food and Drug Administration (FDA). Abrysvo is an unadjuvanted vaccine and is composed of two preF proteins selected to optimize protection against RSV A and B strains.

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Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef.

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XTalks

NOVEMBER 15, 2023

France-based biotech Valneva has won approval from the US Food and Drug Administration (FDA) for its chikungunya vaccine Ixchiq for the prevention of infection from the chikungunya virus. The vaccine is approved for adults 18 years of age and older who are at increased risk of exposure to the virus.

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XTalks

NOVEMBER 5, 2024

The FDA-approved FluMist , featured as one of TIME’s Best Inventions of 2024, exemplifies the appeal of needle-free, self-administered nasal vaccines for influenza. Polyrizon’s focus on intranasal protection aligns with a rapidly expanding market in drug delivery innovation.

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XTalks

NOVEMBER 12, 2024

FDA Approvals and Clinical Trials In February 2024, the US Food and Drug Administration (FDA) approved Ipsen’s Onivyde (liposomal irinotecan) as a first-line treatment for metastatic pancreatic cancer. In a small trial, half of the participants exhibited strong anti-tumor immune responses.

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The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S.

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XTalks

FEBRUARY 3, 2021

COVID-19 vaccines have been a topic of conversation since the outbreak began, and last year’s US Food and Drug Administration (FDA) approval of the Pfizer/BioNTech and Moderna vaccines have given the world hope to defeat the COVID-19 pandemic. One country that has already vaccinated 1.8

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XTalks

JULY 14, 2021

In a press briefing on Monday, the World Health Organization (WHO) responded to questions about COVID-19 vaccine boosters that led to a flurry of misleading headlines in the media about the “dangers” of mixing and matching vaccines. Soumya Swaminathan, during the briefing in which she was asked about COVID-19 vaccine boosters.

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Pharmaceutical Technology

NOVEMBER 22, 2022

Vaccines are our number one weapon in the fight against infectious diseases, but their development has historically involved a long and complex process taking up to a decade. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed. mRNA’s potential for rapid vaccine delivery.

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XTalks

SEPTEMBER 25, 2024

FluMist, a needle-free nasal spray, has been approved by the US Food and Drug Administration (FDA), making it the first and only influenza vaccine in the US that can be self-administered at home. Adults up to 49 years of age can now self-administer the vaccine, while caregivers can administer it to children aged two to 17.

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XTalks

DECEMBER 15, 2021

Ayesha discusses the FDA approval of Biohaven’s intranasal spray Zavegepant for the acute treatment of migraines. The team also talked about results from an early-stage trial evaluating Moderna’s new mRNA-based influenza vaccine in adults. Moderna is also developing a combo vaccine against COVID-19, influenza and RSV.

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Pfizer

JULY 19, 2022

1 Adapted Bivalent Vaccine Candidate. 1 Adapted Bivalent Vaccine Candidate. NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 Tue, 07/19/2022 - 11:22. Booster Series.

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XTalks

JUNE 15, 2022

Last week, Novavax announced that it received positive feedback from the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) regarding the safety and efficacy of its COVID-9 vaccine (NVX-CoV2373). The Novavax COVID-19 Vaccine Candidate. Clinical Trial Results.

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XTalks

NOVEMBER 30, 2023

New FDA-Approved Treatments For HIV HIV treatment involves the administration of combined antiretroviral therapy (ART) to effectively suppress the viral load, maintain or enhance immune function and reduce the risk of opportunistic infections and cancers commonly associated with HIV. aiming to end the HIV epidemic by 2030.

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The Pharma Data

JULY 15, 2021

Antibody and T-cell immune responses strong and stable at eight months after immunization Demonstrated neutralizing antibody activity against the Delta variant (B.1.617.2) of Beth Israel Deaconess Medical Center suggest maturation of B-cell response without further boosting. 1.1.7), Beta (B.1.351), 1.351), Gamma (P.1),

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The Pharma Data

JUNE 18, 2021

First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, 1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. Following today’s FDA approval, the U.S.

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XTalks

NOVEMBER 3, 2021

In this episode, Ayesha discusses the FDA’s authorization of Pfizer/BioNTech’s COVID-19 vaccine for children between five and 11 years of age. The editorial team discussed the positive trial data, the importance of vaccinating kids amid rising infections among younger children, as well as vaccine hesitancy among parents.

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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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Pfizer

NOVEMBER 2, 2022

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Wed, 11/02/2022 - 15:44. Thursday, November 03, 2022 - 06:45am. Ugur Sahin, M.D.,

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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®. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide: Primary Series.

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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

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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STAT News

MARCH 6, 2023

Still, when doctors told her last year that the cancer was growing despite two operations, radiation therapy, and a fifth regimen of chemotherapy, the retired business-meeting facilitator decided to do something unorthodox: spend $83,000 out of pocket on an unproven experimental cancer vaccine.

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The Pharma Data

JULY 18, 2021

Clinical Data Supporting Approval Demonstrated Non-Inferior Immune Responses for the Serotypes Shared with PCV13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). VAXNEUVANCE Elicited Superior Immune Responses for Serotypes 3, 22F and 33F Compared to PCV13, Which Are Major Causes of Disease.

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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

MARCH 29, 2022

Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series.

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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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Advarra

JANUARY 11, 2024

While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines. The mRNA constructs used in COVID-19 vaccines, for example, direct cells to produce a version of the “spike” protein studding the surface of SARS-CoV-2.

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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. Vaccines Taskforce and National Institute for Health Research played pivotal roles in the rapid recruitment and enrollment of volunteers.

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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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XTalks

DECEMBER 17, 2021

The year continued to be dominated by COVID-19, and the second year of the pandemic was all about vaccines. And while over 8 billion doses of vaccines have been administered worldwide, billions more are still needed. And while over 8 billion doses of vaccines have been administered worldwide, billions more are still needed.

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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

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 candidate vaccines were given in two doses, three weeks apart. CHENGDU, China , Feb. CHENGDU, China , Feb.

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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

FEBRUARY 24, 2022

If the EC grants the variation, the decision will be immediately applicable to all 27 EU member states, making booster vaccines available to everyone 12 years and older. . The COVID-19 vaccine booster for individuals 12 through 15 years of age was already granted Emergency Use Authorization by the U.S. and Europe.

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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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