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?

Vaccination 96

Vaccination Vaccine Development Clinical Trials 96

pharmaphorum

JULY 18, 2022

MBA, managing director at CanSino Biologics Europe, tells us about Convidecia, a single dose SARS-CoV-2 vaccine offered as an injectable and inhalant that allows ease of storage, an alternative option for individuals with needle phobias, and robust elongated CD4 and CD8 cellular response. Morgon, PharmD, LL.M, How it works.

Vaccination 133

Vaccination Vaccine Development Immune Response 133

XTalks

SEPTEMBER 21, 2023

announced that the first participant has been dosed in a new Phase I trial for an innovative HIV vaccine candidate, VIR-1388. The trial’s primary objective is to assess the safety of VIR-1388 and its capacity to stimulate a specific immune response against HIV in study participants. Vir Biotechnology, Inc.,

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

pharmaphorum

MARCH 4, 2021

UK chancellor Rishi Sunak has announced a budget loaded with initiatives designed to kick-start the UK’s economy as it recovers from the coronavirus pandemic, with vaccine development, pharma and life sciences playing a key role. This will provide a major incentive to modernise, digitise and grow companies across the country.

Vaccination 105

Vaccination Vaccine Development Life Science 105

XTalks

JANUARY 8, 2021

The US Food and Drug Administration (FDA) released a statement this week about dosing schedules for COVID-19 vaccines, saying that any dose changes would be premature. The FDA therefore continues to recommend the two-dose regimens that both the BioNTech/Pfizer and Moderna vaccines require.

Vaccination 144

Vaccination Vaccine Clinical Trials Clinical Trials 144

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.

Vaccination 105

Vaccination Vaccine Immune Response Trials 105

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, the bivalent RSV prefusion F (RSVpreF) vaccine, is intended for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 years and older.

Vaccination 98

Vaccination Vaccine FDA Approval Protein 98

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.

Vaccination 89

Vaccination Vaccine Trials Clinical Trials 89

XTalks

DECEMBER 14, 2021

Moderna revealed the first interim results from a small, Phase I study of its mRNA-based influenza vaccine, which showed that the vaccine had no significant safety concerns and elicited immune responses against four strains of the influenza virus. First Trial Results for First mRNA Influenza Vaccine.

Vaccination 98

Vaccination Vaccine Immune Response Antibody 98

pharmaphorum

JULY 20, 2021

The EMA has kicked off a rolling review of a COVID-19 vaccine from Sanofi and GlaxoSmithKline, which started a 35,000-patient phase 3 trial in May. The phase 3 trial being run in support of approval is using a two-shot regimen, with the first dose targeting the original SARS-CoV-2 virus and the second targeting beta (B.1.351)

Vaccination 98

Vaccination Vaccine Protein Immune Response 98

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.

Vaccination 59

Vaccination Vaccine Immune Response Protein 59

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.

Vaccination 97

Vaccination Vaccine Clinical Trials Clinical Trials 97

pharmaphorum

SEPTEMBER 22, 2022

Alexandre Le Vert, CEO and co-founder of Osivax, discusses the company’s breakthrough vaccine technology, oligoDOM, and how it’s driving the development of new influenza and SARS-CoV-2 vaccines that attack T-cells, providing a long-lasting effect. The technology. Antibodies cover the pathogen of the virus and neutralise it.

Vaccination 89

Vaccination Vaccine Antibody Clinical Trials 89

XTalks

JULY 28, 2021

Merck has scored US Food and Drug Administration (FDA) approval for its next-generation pneumonia vaccine Vaxneuvance that covers 15 different strains of the pneumococcal bacteria that causes the infection. This is seven more strains than its current winning vaccine Prevnar 13, which registered $5.95

FDA Approval 89

FDA Approval Vaccination Vaccine Immune Response 89

XTalks

MARCH 2, 2021

As the US Food and Drug Administration (FDA) handed out an emergency use authorization (EUA) to Janssen’s COVID-19 vaccine over the weekend — making it the third authorized COVID-19 vaccine in the US — many people became laser-focused on the 66 percent average efficacy of the single-dose shot.

Vaccination 97

Vaccination Vaccine Trials Clinical Trials 97

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

Protein 97

Protein Vaccination Vaccine Trials 97

XTalks

NOVEMBER 1, 2021

On Friday afternoon, the US Food and Drug Administration (FDA) extended the authorization of Pfizer/BioNTech’s COVID-19 vaccine to kids between the ages of five and 11. The agency authorized emergency use of Pfizer/BioNTech’s vaccine for adolescents between 12 and 15 years of age in May.

Vaccination 98

Vaccination Vaccine Immune Response Trials 98

XTalks

MARCH 2, 2021

a pharmaceutical company of Johnson & Johnson, garnered emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its COVID-19 vaccine candidate (Ad26.COV2.S) S) over the weekend, shortly after evaluation of study data from trials of the vaccine by the agency. Janssen Inc.,

Vaccination 98

Vaccination Vaccine Trials Clinical Trials 98

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.

Manufacturing 130

Manufacturing Vaccination Vaccine RNA 130

The Pharma Data

JANUARY 3, 2021

. This trial is the first to evaluate nasally administered Foralumab to improve the immune system’s fight against coronaviruses. Furthermore, nasal anti-CD3 dampens cytotoxic CD8 T cell responses that are known to cause lung damage in COVID-19 patients.”. About Tiziana Life Sciences.

Life Science 40

Life Science Clinical Trials Clinical Trials Antibody 40

XTalks

SEPTEMBER 23, 2021

NYSE: PFE ) and BioNTech SE ( Nasdaq: BNTX ) announced the very first results from a pivotal trial being conducted for their COVID-19 vaccine for children on Monday. The results showed that the vaccine was safe, well-tolerated and produced robust neutralizing antibody responses in children five to 11 years old.

Vaccination 98

Vaccination Vaccine Trials Antibody 98

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.

Vaccination 103

Vaccination Vaccine Insulin Trials 103

XTalks

JULY 2, 2021

There have been growing reports of women experiencing changes in their menstrual cycle after receiving a shot of a COVID-19 vaccine. Some women have said they got their periods early following vaccination, or that their periods were unusually heavy and/or painful. Related: Moderna’s COVID-19 Vaccine Effective Against New Variants.

Vaccination 105

Vaccination Vaccine Protein Immune Response 105

XTalks

SEPTEMBER 16, 2021

Despite COVID-19 vaccine booster doses being offered to the general public in places like France and Israel, the US Food and Drug Administration (FDA) remains tight-lipped on the subject and has yet to take a formal stance. The two were the agency’s top vaccine reviewers and retired from their roles.

Vaccination 52

Vaccination Vaccine Immune Response Clinical Trials 52

XTalks

NOVEMBER 10, 2020

Update (November 11, 2020): Quebec-based biopharmaceutical company Medicago has announced positive results from a Phase I trial of its candidate plant-derived vaccine. Interim results of the trial show that all participants developed an antibody response after two doses of the COVID-19 adjuvanted vaccine candidate.

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

Drug Discovery World

MAY 6, 2024

Thanks to a prestigious academic legacy, Europe has long been a dominant region for life sciences. Europe is traditionally a life sciences powerhouse, with a strong tradition in pharmaceutical discovery. The oldest, still active pharmaceutical company worldwide, Merck, started life in 1668 in Darmstadt, Germany.

Drugs 59

Drugs Life Science Gene Editing Gene 59

XTalks

NOVEMBER 30, 2023

The safety and efficacy of Cabenuva were established through two randomized, open-label, controlled clinical trials involving 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) before initiating Cabenuva treatment. Additionally, Gag-specific CD8+ T cells demonstrated an increase of 1.7

FDA Approval 111

FDA Approval Gene Therapy Clinical Trials Clinical Trials 111

XTalks

NOVEMBER 10, 2020

Update (November 10, 2020): Pfizer and BioNTech announced in a press release yesterday that their candidate COVID-19 vaccine was found to be more than 90 percent effective in preventing infection by the novel coronavirus in Phase III trials. The participants had no prior evidence of being exposed to SARS-CoV-2.

Vaccination 75

Vaccination Vaccine Trials Clinical Trials 75

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 Combating COVID-19 Vaccine Misinformation.

Vaccination 98

Vaccination Vaccine Immune Response Manufacturing 98

pharmaphorum

JANUARY 8, 2021

As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses. When the UK announced the approval of the Pfizer-BioNTech and Oxford/AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.

Vaccination 59

Vaccination Vaccine Immune Response Trials 59

XTalks

JULY 30, 2020

The research provides an even more compelling reason to get vaccinated for those on the fence about the shot’s effectiveness at preventing the seasonal flu. These groups should have the highest vaccination rates because they are the most at risk; however, our findings show the opposite – flu vaccinations are under-utilized,” said Roshni A.

Vaccination 85

Vaccination Vaccine Immune Response Protein 85

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.

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

Pharmaceutical Technology

JULY 22, 2022

In addition, immunity against the infection is found to wane for both previously infected individuals and the vaccinated. Kai Kupferschmidt, a science journalist, shared an article on the rising measles cases worldwide. Measles is highly contagious and therefore is more visible when vaccine levels decline, the article noted.

Vaccination 130

Vaccination Vaccine Life Science Immune Response 130

pharmaphorum

JANUARY 8, 2021

As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses. When the UK announced the approval of the Pfizer-BioNTech and Oxford-AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.

Vaccination 53

Vaccination Vaccine Immune Response Trials 53

pharmaphorum

DECEMBER 15, 2020

million (around $56 million) in a Series B funding round to take its novel group B streptococcus (GBS) vaccine into mid-stage clinical trials. MinervaX is one company that wants to change this situation, which aims to prevent the spread of GBS infections using a vaccine instead of using an antibacterial agent.

Bacteria 52

Bacteria Vaccination Vaccine Immune Response 52

pharmaphorum

AUGUST 27, 2020

The Biotechnology and Biological Sciences Research Council (BBSRC), part of UK Research and Innovation (UKRI), works with universities, research organisations, businesses, charities, and government to develop a supportive ecosystem. The common challenge is undertaking lengthy and capital-intensive phase II/III clinical trials.

Vaccination 111

Vaccination Vaccine Life Science Clinical Trials 111

The Pharma Data

DECEMBER 23, 2020

Additionally, Phase 1 clinical data found INO-4800 to have a favorable safety and tolerability profile with no serious adverse events reported; only six Grade 1 adverse events (AEs) were observed, primarily minor injection site reactions. . ” Findings from the Phase 1 Clinical Trial.

DNA 40

DNA Vaccination Vaccine Immune Response 40