Drug Discovery World

AUGUST 23, 2023

The US Food and Drug Administration (FDA) has approved the first vaccine for pregnant individuals to prevent respiratory syncytial virus (RSV) in infants. Edited by Diana Spencer, Senior Digital Content Editor, Drug Discovery World The post FDA approves RSV vaccine to protect babies from birth appeared first on Drug Discovery World (DDW).

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Drug Discovery World

FEBRUARY 6, 2024

The first UK patients have received an mRNA cancer therapy – mRNA-4359 – as part of a Phase I/II clinical trial investigating its potential for treating melanoma, lung cancer and other solid tumour cancers. The trial is sponsored by Moderna through the Moderna-UK Strategic Partnership.

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The Pharma Data

MAY 16, 2022

The profound health and economic impact of the Pfizer-BioNTech vaccine during its first year of rollout in the US is described in detail in a new study in the peer-reviewed Journal of Medical Economics. It is estimated that in 2021 the vaccine, the most widely used against COVID-19 in the US, prevented 8.7

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The Pharma Data

SEPTEMBER 25, 2020

A trial of a new vaccine that appears to train the immune system to fight coronavirus has begun in the UK. The trial on 10,000 people will now see if the vaccine can prevent people getting ill. Some of the vaccines being developed for Covid-19 use either completely new or barely proven technologies. .

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The Pharma Data

DECEMBER 17, 2020

COVID-19 vaccine developers are faced with an ethical quandary — whether to let phase 3 trial participants become “unblinded” and to receive authorized vaccines as they become available, which could hinder the collection of meaningful trial data. Pfizer, which has received emergency approvals in the U.S.

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Drug Discovery World

JULY 12, 2022

Urgent access to vaccines that can fight and prevent infections, and curb the risk of antimicrobial resistance (AMR) is needed to save lives, according to a report by the World Health Organisation (WHO). . More so, they currently have a very weak vaccine pipeline due to a low number of candidates and feasibility. type b) Tuberculosis?

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Drug Discovery World

AUGUST 24, 2022

The trial will see participants receive either a 14-day course of 600 mg tecovirimat twice daily or a matched placebo treatment. As a community-based trial, participants will take the treatment or placebo in their own homes. The trial looks to include at least 500 participants in the UK. .

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The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov.

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Codon

JANUARY 21, 2024

Today, refined versions of these human challenge studies have become standard practice in testing vaccines for vector-borne diseases (e.g., Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October.

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Drug Discovery World

FEBRUARY 9, 2023

Why data from a Phase III clinical trial offers promise for patients with a deadly form of brain cancer. A Phase III clinical trial has produced promising results for a cancer vaccine targeting patients with a new or recurrent glioblastoma. receiving existing treatments.

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H1 Blog

SEPTEMBER 26, 2023

Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. When it comes to developing new treatments and vaccines, the development timeline is often long and arduous, especially outside of the U.S. Additionally, how do you ensure that the vaccine distribution is equitable?

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Drug Discovery World

SEPTEMBER 13, 2023

27% of patients with non-vaccinal SARS-COV-2 positive serology corresponded to the previously described psychotic disorder subgroup associating HERV-W expression. The first months of the trial have already confirmed that the W-ENV protein is present in the blood of over 25% of patients with persistent syndromes who suffered from Long Covid.

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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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Eye on FDA

DECEMBER 10, 2020

Today the Food and Drug Administration will hold a meeting of the Vaccines and Related Biologics Advisory Committee (VRBAC) to consider the application for an Emergency Use Authorization (EUA) submitted by Pfizer/BioNTech for their investigative vaccine for COVID-19. After nearly 40 years, a vaccine still eludes us.

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The Pharma Data

AUGUST 17, 2020

More than 100,000 people have signed up to take part in future NHS trials of a coronavirus vaccine – but more volunteers are needed, researchers say. Kate Bingham, who chairs the UK’s vaccine taskforce, said: “These trials are safe, please sign up. Image copyright. Volunteers can register online.

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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. 12, 2020 – The U.S.

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The Pharma Data

DECEMBER 3, 2020

Another record-breaking day of COVID-19 hospitalizations and deaths underscored Redfield’s grim warning. The number of people hospitalized for COVID-19 on Wednesday passed 100,000, nearly double the highest point seen last spring. With hospitals filling up in multiple states, the days ahead do appear bleak.

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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

JANUARY 29, 2021

EU Regulator Approves Oxford-AstraZeneca COVID-19 Vaccine. 29, 2021 — European Union regulators have authorized the AstraZeneca COVID-19 vaccine for use in adults, CBS News reported Friday. The move comes after the European Medicines Agency has been criticized for not moving fast enough to vaccinate its population.

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The Pharma Data

DECEMBER 21, 2020

The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020. “We Mascha Binder, M.D.,

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The Pharma Data

DECEMBER 14, 2020

14, 2020 (Healthday News) — The first shipments of nearly 3 million doses of the Pfizer coronavirus vaccine were on their way to hospitals in all 50 U.S. Because the vaccines can cause side effects including fevers and aches, hospitals have said they will stagger vaccinations among their workers. MONDAY, Dec.

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The Pharma Data

MARCH 14, 2023

QDENGA is the only dengue vaccine approved in Brazil for use in individuals regardless of previous exposure to dengue and without the need for pre-vaccination testing. QDENGA is the only dengue vaccine approved in Brazil for use in individuals regardless of previous exposure to dengue and without the need for pre-vaccination testing.

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The Pharma Data

MARCH 2, 2021

Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older. The terms of the EUA allow use of the vaccine while more data are gathered.

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The Pharma Data

DECEMBER 11, 2020

70 Percent Efficacy Found for Oxford COVID-19 Vaccine. 11, 2020 — The ChAdOx1 nCoV-19 vaccine has an overall efficacy of 70.4 Participants in the vaccine group received two doses containing 5 x 10 10 virus particles (standard dose; SD/SD cohort); a subset in the U.K. The researchers found that vaccine efficacy was 62.1

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The Pharma Data

DECEMBER 8, 2020

The COVID-19 vaccine under development by China’s Sinopharm is showing efficacy of 86%, health authorities from the United Arab Emirates reported this morning. The efficacy rating followed an interim report of ongoing human trials conducted in that country, CNBC reported. The vaccine was also demonstrating a strong safety profile.

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The Pharma Data

MARCH 25, 2021

European Medicines Agency to Conduct First-Ever Parallel Assessment of a Medicinal Product, Takeda’s Dengue Vaccine Candidate (TAK-003), for use in the EU; Countries Outside of the EU through the EU-M4all (Previously Article 58) Procedure.

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The Pharma Data

JUNE 17, 2022

In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S.

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Drug Discovery World

JANUARY 11, 2024

Messenger RNA therapies are also currently being investigated in other rare inherited metabolic diseases – propionic and methylmalonic acidaemias – in global clinical trials sponsored by Moderna, including at Great Ormond Street Hospital for Children. We believe it can now do the same for rare diseases.”

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The Pharma Data

SEPTEMBER 14, 2020

A new antibody treatment is to be trialled on Covid-19 patients in UK hospitals. It forms part of the UK Recovery Trial, which found that a cheap steroid called dexamethasone could save lives. We need to know, and the way to know is to do the trials that will tell us whether that hope turns into reality.”.

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The Pharma Data

JUNE 7, 2023

This is the first time an RSV vaccine for older adults has been granted European Marketing Authorisation. This authorisation for Arexvy means eligible adults can be vaccinated against RSV disease for the first time, reinforcing GSK’s long history of vaccine innovation. The vaccine was generally well tolerated.

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Drug Target Review

JANUARY 23, 2024

Vaccinations against tumour antigens that are shared between tumours, or tumour antigens that arise from mutations unique to individual tumours, represent promising strategies. Cell-based therapies, such as tumour-infiltrating lymphocyte (TIL) therapy, have also drawn significant attention following promising results in a melanoma trial.

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The Pharma Data

DECEMBER 14, 2020

14, 2020 — The Pfizer-BioNTech COVID-19 vaccine has received the first emergency use authorization (EUA) for a COVID-19 vaccine in the United States. The vaccine is administered in two doses three weeks apart. Researchers found the vaccine was 95 percent effective in preventing COVID-19. MONDAY, Dec. Redfield, M.D.,

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The Pharma Data

SEPTEMBER 1, 2020

Sanofi is halting clinical trials treating serious COVID-19 patients with its Kevzara drug after the data proved inconclusive. The Phase 3 trial did not meet the primary or secondary endpoints compared with placebo and established hospital care. Conor Kavanagh. Source link.

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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. Trials are also being run in the U.S.,

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The Pharma Data

DECEMBER 2, 2020

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. This License Agreement represents an important corporate milestone.

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The Pharma Data

DECEMBER 8, 2020

AstraZeneca (AZ) and the University of Oxford have presented new data from a “pooled analysis” of phase 3 trials evaluating COVID-19 vaccine AZD1222 at two different dose regimens, demonstrating an average efficacy of 70.4 percent effective “at least 14 days” following the second injection.

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The Pharma Data

JANUARY 5, 2021

Food and Drug Administration said Monday that any American who gets the Moderna or Pfizer coronavirus vaccines must get two full doses, despite international debate on possible ways to stretch vaccine supply. “These are all reasonable questions to consider and evaluate in clinical trials. In the U.K.,

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