STAT News

OCTOBER 12, 2022

Merck on Wednesday agreed to extend an ongoing collaboration with Moderna to develop a personalized vaccine for the treatment of patients with skin cancer. Moderna is getting $250 million from Merck to secure opt-in rights to the cancer vaccine candidate, called mRNA-4157.

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BioSpace

JULY 12, 2023

Following the regulator’s request for more data beyond the scope of its Phase III TIDES trial, Takeda decided to voluntarily withdraw the Biologics License Application for its TAK-003 dengue vaccine.

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Pharmaceutical Technology

AUGUST 14, 2022

Novavax and its partner SK bioscience have obtained a Post Approval Change Application approval from the Korean Ministry of Food and Drug Safety (KMFDS) for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), to be used in adolescents of the age 12 to 17 years. It enrolled 2,247 adolescents across 73 US sites.

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Drug Discovery World

JANUARY 8, 2024

UK-based Barinthus Biotherapeutics, the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Oxford are working together to fast-track the development of a vaccine candidate for the prevention of Middle East Respiratory Syndrome (MERS).

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Drug Discovery World

MARCH 27, 2024

The vaccines currently in late-stage development hold promise in tackling the disease burden of tuberculosis (TB), says data and analytics company GlobalData on World Tuberculosis Day 2024. According to GlobalData, there are 11 vaccines in late-stage development for TB globally.

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Drug Discovery World

AUGUST 12, 2022

Pfizer has launched a Phase III clinical trial of a vaccine to protect people against Lyme disease, in collaboration with pharmaceutical company Valneva. . The trial will enrol up to 6,000 participants aged five years and older and will be conducted across 50 sites where Lyme disease is highly endemic. References .

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Pharmaceutical Technology

AUGUST 23, 2022

5-adapted bivalent vaccine for Covid-19 in people aged 12 years and above. 1-adapted vaccine. The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution. 5-adapted bivalent vaccine will be made readily available for shipping. 5-adapted bivalent vaccine.

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XTalks

AUGUST 13, 2020

As the rush for a COVID-19 vaccine continues, healthcare services company Kaiser Permanente has joined in on the clinical testing of Pfizer Inc. and BioNTech’s lead vaccine candidate in a Phase III trial being conducted at sites in California and Oregon.

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BioPharma Reporter

SEPTEMBER 15, 2022

Pfizer will submit a Biologics License Application (BLA) for its investigational pentavalent meningococcal vaccine (MenABCWY) to the US Food and Drug Administration (FDA) later this year, following positive top-line results from a Phase 3 trial.

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XTalks

SEPTEMBER 5, 2023

Vaccines have been an integral piece of the global public health toolbox for over 200 years, but the COVID-19 pandemic brought about a new era in vaccine development with renewed interest in mRNA technology and unprecedented accelerated regulatory approvals. What are the major challenges you’re facing right now in vaccine development?

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Drug Discovery World

OCTOBER 3, 2023

The R21/Matrix-M malaria vaccine has been recommended for use by the World Health Organization’s Strategic Advisory Group of Experts (SAGE) and the Malaria Policy Advisory Group (MPAG). The developers expect additional regulatory approvals will follow shortly and R21/Matrix-M vaccine doses could be ready to begin wider roll-out next year.

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Pharmaceutical Technology

OCTOBER 28, 2022

On 24 October, American vaccine developer Vaxcyte shared positive topline data from a Phase I/II study of its multivalent conjugate pneumococcal vaccine VAX-24 , bringing the 24-valent pneumococcal jab one step closer to market. This is in addition to its long-available pneumococcal polysaccharide vaccine PPSV23.

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XTalks

JULY 19, 2022

The US Food and Drug Administration (FDA) has given emergency use authorization (EUA) to Novavax’s COVID-19 vaccine, making it the fourth authorized vaccine in the US against COVID-19. The vaccine is branded as Nuvaxovid outside the US with approvals/authorizations in Canada, the EU, UK, Australia and South Korea.

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BioPharma Reporter

JUNE 14, 2021

Ocugen will pursue submission of a biologics license application (BLA) in the US for the COVID-19 vaccine candidate, COVAXIN, rather than a EUA application. The company believes that the differentiated vaccine has the potential to address variants, as well as planning to undertake paediatric and booster trials.

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The Pharma Data

DECEMBER 2, 2020

This License Agreement represents an important corporate milestone. The License provides EYAM with the exclusive right to develop several proprietary COVID-19 vaccine candidates in a self-amplifying mRNA vaccine platform. EYAM anticipates rapid commencement of animal trials for these COVID-19 vaccine candidates.

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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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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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XTalks

NOVEMBER 4, 2022

Pfizer announced positive top-line data from a Phase III trial evaluating its respiratory syncytial virus (RSV) prefusion vaccine candidate, RSVpreF (or PF-06928316) for pregnant individuals to help protect their infants from RSV disease after birth. Related: Pfizer to Acquire RSV Antiviral Developer ReViral in $525 Million Deal.

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Drug Discovery World

OCTOBER 27, 2023

HB-400, a novel arenaviral therapeutic vaccine developed by HOOKIPA Pharma and Gilead Sciences, has been shown to generate robust T cell responses specific to hepatitis B virus with high antibody levels in a preclinical setting. A Phase I clinical trial to evaluate the safety and tolerability of HB‑400 in humans is ongoing.

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XTalks

JULY 25, 2023

Emergent BioSolutions, a multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland, has achieved a significant milestone with the approval of its Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted) vaccine by the US Food and Drug Administration (FDA). How Does Cyfendus Work? mL for intramuscular injection.

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.

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XTalks

NOVEMBER 29, 2021

Pfizer and vaccine partner BioNTech shared positive long-term data last week that shows their COVID-19 vaccine remains effective for at least four months in adolescents 12 to 15 years of age. The vaccine also maintained a good safety profile with no serious side effects.

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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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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S.

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XTalks

APRIL 2, 2021

Pfizer released new COVID-19 vaccine trial results this week from its ongoing clinical studies, which include data showing that its COVID-19 mRNA vaccine is 100 percent effective in children between the ages of 12 and 15 and has a 91 percent efficacy against variants with protection lasting at least six months.

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The Pharma Data

NOVEMBER 3, 2020

The Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to fund development of a potential COVID-19 vaccine from China’s Clover Biopharmaceuticals with a global phase 2/3 study and through licensing and distribution. million for an initial trial of SCB-2019 in Australia that enrolled 150 participants.

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XTalks

OCTOBER 25, 2023

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s supplemental biologics license application (sBLA) for a self-administered option of its nasal influenza vaccine FluMist Quadrivalent. FluMist has been in the market since 2003 and is the only intranasal spray vaccine option against flu.

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pharmaphorum

MARCH 22, 2022

Bavarian Nordic has licensed rights to its respiratory syncytial virus (RSV) vaccine in China and certain other Asian markets to Shanghai’s Nuance Pharma in a $225 million deal. GSK’s jab has however run into trouble in the maternal immunisation setting, halting three trials while it investigates a safety signal.

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The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. “Our MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio.

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BioSpace

JUNE 16, 2022

???????Bavarian Nordic announced that the upcoming Phase III trial for its COVID-19 booster candidate has been redesigned to compete against licensed mRNA-based vaccines.

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Pharmaceutical Technology

JULY 29, 2022

The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease.

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Delveinsight

SEPTEMBER 7, 2021

Pfizer’s RSV Vaccine enters in the late-stage of clinical trials. Recently, the US Food and Drug Administration has fully authorized its SARS-CoV-2 or COVID-19 vaccine. Recently, the US Food and Drug Administration has fully authorized its SARS-CoV-2 or COVID-19 vaccine.

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pharmaphorum

JANUARY 18, 2022

Cancer Research UK’s Centre for Drug Development, working with the Ludwig Institute for Cancer Research and Vaccitech, has begun a phase I/IIa clinical trial of a new lung cancer vaccine. Vaccitech and the Ludwig Institute are providing the drug while the Centre manages the trial and provides funding.

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XTalks

MARCH 1, 2021

(NYSE: PFE ) and BioNTech SE (Nasdaq: BNTX ) have announced that they are beginning a trial to evaluate the safety and efficacy of a third booster dose for their COVID-19 vaccine (BNT162b2), as well as new vaccine variants. The study will be a part of current Phase I, II and III trials.

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pharmaphorum

AUGUST 16, 2020

The European Commission has placed its first advance order for a coronavirus vaccine, snapping up 300 million doses of AstraZeneca’s ChAdOx1 candidate developed by the University of Oxford, with an option on another 100 million. The EU says its advance purchase order will finance part of the upfront costs of developing the vaccine.

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pharmaphorum

SEPTEMBER 8, 2022

A malaria vaccine developed by members of the University of Oxford team behind the AstraZeneca COVID-19 jab has been hailed as a possible game-changer in the fight against the deadly parasitic infection. The post High hopes as new malaria vaccine shows unprecedented efficacy appeared first on.

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pharmaphorum

NOVEMBER 24, 2020

The developer of Russia’s COVID-19 vaccine Sputnik V has pledged to make it available for less than $10 per dose – or $20 per two-dose course – on the same day as revealing new clinical data with the shot. Pfizer and Moderna’s vaccines require much lower temperatures to prevent their active ingredients from breaking down.

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