Pharmaceutical Technology

JULY 27, 2022

Novavax has r eceived expanded approval for provisional registration from the Australian Therapeutic Goods Agency (TGA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use in adolescents aged 12 to 17 years. It is the first protein-based vaccine to be offered in Australia for adolescents aged 12 to 17 years.

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XTalks

FEBRUARY 19, 2024

Moderna has been testing an experimental mRNA vaccine aimed at combating the human cytomegalovirus (CMV), which poses significant health risks to newborns and immunocompromised patients. The team used the data and patient samples from a gB/MF59 Phase II trial in adolescent girls as a benchmark to assess the new mRNA-based vaccine.

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Pharmaceutical Technology

OCTOBER 26, 2022

SK bioscience has signed a new collaboration agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) to develop messenger ribonucleic acid (mRNA) vaccines for infectious diseases. The company has obtained the newest vaccine platform technologies such as bacterial culture, cell culture and genetic recombination.

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Drug Discovery World

APRIL 14, 2023

Clinical trials are, undoubtedly, an essential part of the drug development process, providing us with valuable information about the safety and efficacy of new treatments and therapies. of participants 2 Covid-19 vaccination trials. In fact, these demographics which make up 13.8%

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Pharmaceutical Technology

DECEMBER 27, 2022

Along the way, mergers and acquisitions continued to happen, new drugs and devices got approved, and innovations in the clinical trial industry were introduced. A few months later, the monkeypox outbreak showed the difficulty in accessing vaccines and antivirals despite a plan to stockpile them. Tracking the news.

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pharmaphorum

JUNE 11, 2021

The development of vaccines for COVID-19 has been a masterclass in effective collaboration and applied digitisation in healthcare. Abel Archundia discusses how COVID-19 has highlighted the importance of securing clinical trials against cyber threats. billion doses were administered to people worldwide.

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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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Advarra

MARCH 31, 2023

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. A key part of the IBC’s evaluation is assessing the risks posed by the engineered genetic materials.

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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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Cloudbyz

MAY 22, 2023

The race to create a vaccine for the novel coronavirus, SARS-CoV-2, saw an unprecedented global scientific collaboration. This international effort culminated in the successful clinical trials and subsequent rollout of several effective COVID-19 vaccines in record time.

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Drug Discovery Today

JULY 28, 2020

Cancer Research UK, the University of Southampton and Touchlight Genetics, a London based biotechnology company, today (Wednesday) announce a new clinical development partnership to progress a therapeutic DNA vaccine, TGL-100, into an early phase clinical trial targeting head and neck squamous cell carcinoma (HNSCC).

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pharmaphorum

JULY 6, 2021

A peptide vaccine developed by Australia’s Imugene has reduced tumour size in around half of patients with HER2-positive gastric or gastroesophageal junction (GEJ) cancer in a phase 2 trial. The post Imugene HER2 vaccine hits target in stomach cancer trial appeared first on.

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XTalks

NOVEMBER 23, 2020

Adding to recent announcements from Pfizer and Moderna on the efficacy of their COVID-19 vaccine candidates, AstraZeneca and Oxford revealed today that their vaccine contender is 70 percent effective, and could be as high as 90 percent. Oxford-AstraZeneca COVID-19 Vaccine Induces Immune Responses in Early Clinical Trials.

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XTalks

FEBRUARY 25, 2022

There has been increasing awareness around the need for improving inclusion and diversity in clinical trials. As such, there has been a growing emphasis on efforts to achieve better and more accurate representations of minority and underrepresented populations like Black people in clinical studies.

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ACRP blog

OCTOBER 10, 2023

In recognition of October being Breast Cancer Awareness Month , ACRP recently went behind the scenes with a clinical research coordinator on the study team for a bold Cleveland Clinic investigation of a vaccine aimed at preventing triple-negative breast cancer (TNBC), the most aggressive and lethal form of the disease.

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The Pharma Data

FEBRUARY 25, 2021

Takeda Provides Updates on Phase 1/2 Clinical Trials of Novavax’ and Moderna’s COVID-19 Vaccine Candidates in Japan. – Phase 1/2 immunogenicity and safety trials designed to include 200 healthy Japanese adults followed for 12 months after second vaccination. TAK-919 clinical trial.

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Drug Discovery World

FEBRUARY 8, 2023

A diversity study has shown that clinical trials should use real world diseases epidemiology data, rather than US Census Bureau race and ethnicity data, to ensure enrolment reflects the populations affected by different diseases. For example, US Census Bureau data indicates 13.4%

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pharmaphorum

OCTOBER 2, 2020

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. But this does not mean that the CHMP is ready to make a conclusion on the safety and efficacy of the vaccine.

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Imperical Blog

MAY 20, 2020

Professionally, especially in the world of clinical research, the opposite is happening. The race for testing and vaccines has driven down bureaucracy for the sake of critical efficiency. More importantly, trials will become a part of life and something almost every person in the world will be on at any given time. and Europe.

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XTalks

SEPTEMBER 8, 2020

The company has signed on to help manufacture AstraZeneca’s COVID-19 vaccine candidate, AZD1222, intended to protect against the SARS-CoV-2 novel coronavirus. AMRI is proud to partner with AstraZeneca in pursuit of a vaccine that could protect people against the coronavirus pandemic,” said John Ratliff, CEO of AMRI, in a statement.

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XTalks

MAY 7, 2021

As Novavax awaits emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its protein-based COVID-19 vaccine NVX-CoV2373, the company shared new data this week on the vaccine’s efficacy against the South African B.1.351 These results came from data from Novavax’s Phase III UK trial where B.1.117

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Pharmaceutical Technology

MARCH 1, 2023

The Covid-19 pandemic led to massive developments and scientific advances within the field of messenger ribonucleic acid (mRNA) vaccines. Pfizer /BioNTech and Moderna’s mRNA-based vaccines were the first to receive emergency use authorisation (EUA) out of all other Covid-19 vaccines under development in late 2020.

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XTalks

SEPTEMBER 15, 2020

A vaccine developed by Swedish company Diamyd Medical has demonstrated significant treatment efficacy in a predefined genetic subgroup of individuals with type 1 diabetes in a Phase IIb clinical trial. Diamyd Medical is a clinical-stage biopharmaceutical company that develops therapies for type 1 diabetes.

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pharmaphorum

SEPTEMBER 17, 2020

US medical experts are reportedly concerned that a neurological side effect picked up in AstraZeneca’s closely-watched COVID-19 vaccine trial could compromise the whole project, as the FDA weighs whether to give the go ahead for US studies to resume. Nath told CNN: “The highest levels of NIH are very concerned.

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pharmaphorum

NOVEMBER 9, 2020

As the death toll from COVID19 inexorably mounts, Pfizer and BioNTech have announced that their COVID-19 vaccine candidate is more than 90% effective at countering the disease in an interim analysis. Top-line results come from a phase 3 trial of the candidate known as BNT162b2 and an evaluation of 94 cases from the trial of 43,538 patients.

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Drug Discovery World

JANUARY 19, 2024

Clinical trial will test novel inhaled TB vaccine A new study will compare whether giving tuberculosis vaccine by inhalation is better at protecting against tuberculosis (TB) than injection into the skin. Revealed: How Covid-19 variants stay ahead of immune defences Recent SARS-CoV-2 variants such as BA.4

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Scienmag

JUNE 27, 2021

Study points towards role of gut microbiome in vaccine effectiveness Credit: Image by Dr. Hiroshi Kiyono, CC BY 4.0 A new vaccine to protect against deadly cholera has been made by grinding up genetically modified grains of rice. The first human trial has shown no obvious side effects and a good immune response.

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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. The vaccine is given in two doses.

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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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XTalks

JUNE 16, 2021

Novavax shared the latest data from its ongoing late-stage COVID-19 vaccine trial, which shows that its yet-to-be authorized shot provides 100 percent protection against moderate and severe disease and has an overall efficacy of 90.4 Related: Latest Data from Novavax COVID-19 Vaccine Trial Involving B.1.351

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Delveinsight

AUGUST 26, 2021

Shape’s RNA editing technology could potentially modify the amount of a key regulatory protein in the body or treat genetic diseases. The company then utilizes the de-identified records to improve the design of clinical trials and quality of life measurements. and Leila Zegna, director of the Kabuki Syndrome Foundation.

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Drug Discovery World

MAY 17, 2024

From a weight loss drug that prevents heart attacks and a gene therapy that restores hearing, to a vaccine that can treat viruses that don’t exist yet, our chosen news stories this week all represent potential breakthroughs in their respective fields.

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pharmaphorum

DECEMBER 1, 2020

Pfizer and BioNTech have filed their COVID-19 vaccine with the European medicines regulator, paving the way for a potential approval before the end of the year. The companies initially filed the nonclinical data and other technical data, followed by emerging clinical trial results.

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Pharmaceutical Technology

MAY 2, 2023

IO agents include the classes of immune checkpoint modulators, cell therapies, bispecific antibodies, oncolytic viruses, therapeutic vaccines, and cytokines. All currently approved CAR-Ts are autologous, with the patient’s T-cells being genetically engineered to target antigens expressed by the cancerous cells.

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The Pharma Data

NOVEMBER 16, 2020

16, 2020 — Scientists are reporting early success with an experimental herpes vaccine that uses a genetically modified version of the virus. So far, the vaccine has only been tested in lab animals. But scientists hope the genetic tweak will eventually allow the vaccine to succeed where past ones have failed.

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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

SEPTEMBER 14, 2020

. AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA). Source link.

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