XTalks

NOVEMBER 6, 2020

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. Related: Red Meat Allergy Test Gets FDA Clearance. “We

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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. In the trial, the vaccine was injected directly into the lymph nodes of type 1 diabetic individuals.

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pharmaphorum

AUGUST 23, 2021

The COVID-19 pandemic accelerated the development of mRNA-based vaccines, and its influence has now extended to DNA-based shots as well, with Zydus Cadila’s ZyCoV-D getting emergency use authorisation in India. Proponents of the approach claim that DNA vaccines may have advantages over other technologies like mRNA.

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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

DECEMBER 20, 2021

The World Health Organization (WHO) has backed Novavax’s COVID-19 vaccine, Covovax (NVX-CoV2373), by granting it an emergency use listing (EUL). The company is awaiting on authorization of its vaccine from regulatory health bodies around the world, including the US Food and Drug Administration (FDA) and Health Canada.

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XTalks

AUGUST 16, 2021

The US Food and Drug Administration (FDA) has amended its emergency use authorizations (EUA) for both the Pfizer and Moderna COVID-19 vaccines to incorporate a third dose for immunocompromised individuals. A small study from John Hopkins University has shown that a third dose of a COVID-19 vaccine could indeed help immunocompromised patients.

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pharmaphorum

MARCH 3, 2021

Novavax hopes its COVID-19 vaccine could be filed in the US in the second quarter, following a potential approval from the UK regulator in the coming weeks. Novavax’s vaccine is a sequence of protein engineered from the genetic sequence of the SARS-CoV-2 virus that mimics the “Spike” protein found on the pathogen’s surface.

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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 That analysis also showed that the Novavax COVID-19 vaccine was 96.4

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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, 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.

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XTalks

NOVEMBER 12, 2024

Routine screenings are currently not widely available, so patients and healthcare providers must remain vigilant, especially in people with higher risk factors, such as a family history of pancreatic cancer, chronic pancreatitis or certain genetic conditions.

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Research FDA Approval Trials Clinical Trials 105

pharmaphorum

SEPTEMBER 1, 2020

AstraZeneca has expanded development of COVID-19 vaccine AZD1222 into the US, beginning a phase 3 clinical trial across all adult age groups. The UK pharma said that the trial will recruit up to 30,000 adults aged 18 years or over to assess the safety, efficacy and immune response.

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pharmaphorum

JULY 14, 2021

AstraZeneca and Johnson & Johnson are both exploring ways to modify their COVID-19 vaccines to minimise the risk of severe blood clotting reactions that are seen – albeit rarely – in some people receiving the jabs. It suggests that AZ may be able to have a new version that sidesteps the clotting issue by next year.

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Scienmag

NOVEMBER 6, 2020

New study demonstrates candidate’s potential to generate antibodies, limit viral shedding Credit: Craig Chandler, University of Nebraska-Lincoln A genetically edited form of a herpes simplex virus — rewired to keep it from taking refuge in the nervous system and eluding an immune response — has outperformed a leading vaccine candidate (..)

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pharmaphorum

NOVEMBER 28, 2021

1.1.529 variant of COVID-19 – now christened Omicron – leading vaccine manufacturers have said they are poised to develop new shots if needed. Other vaccine manufacturers have also responded to the new variant. With governments around the world announcing measures to curb the new B.1.1.529

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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. BlueWillow Biologics announces positive interim results from Phase 1 Trial of Intranasal Anthrax Vaccine. BlueWillow shared little data about how the vaccine performed in its interim analysis.

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Scienmag

JUNE 25, 2021

The latest in […].

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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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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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The Pharma Data

JUNE 29, 2021

A sub-analysis from the Oxford-led COV001 and COV002 trials with Vaxzevria induced strong immune responses following either a prolonged second dose interval of up to 45 weeks or following a third boosting dose. There is an excellent response to a second dose, even after a 10 month delay from the first.”.

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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. The gene edit prevents the virus from performing its normal evasive maneuver: hiding out in nervous system cells in order to elude the immune system. MONDAY, Nov.

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The Pharma Data

APRIL 15, 2022

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced positive results from a Phase 2/3 clinical trial evaluating the safety, tolerability and immunogenicity of a 10-µg booster (third) dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children 5 through 11 years of age. About Pfizer: Breakthroughs That Change Patients’ Lives.

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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.

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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. Source link.

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pharmaphorum

OCTOBER 6, 2020

The European Medicines Agency has begun a second “rolling review” of a potential coronavirus vaccine jointly developed by BioNTech and Pfizer, setting up a race with a rival from AstraZeneca and Oxford University. To date, the trial has enrolled approximately 37,000 participants with more than 28,000 having received their second vaccination.

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XTalks

JANUARY 11, 2023

It also seems to be very adept at evading the immune response owing to a plethora of mutations that makes it immune evasive. “It Importantly, preliminary data shows that bivalent COVID-19 vaccines that target the parent strain of Omicron should provide protection against XBB.1.5 In the northeast of the country, XBB.1.5

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pharmaphorum

FEBRUARY 28, 2021

The FDA has approved emergency use of a third COVID-19 vaccine from Johnson & Johnson’s Janssen Biotech unit, the day after an advisory committee concluded it was safe and effective. Today, FDA issued an emergency use authorization (EUA) for the third vaccine for the prevention of #COVID19 caused by SARS-CoV-2. Janssen’s Ad26.COV2.S

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The Pharma Data

DECEMBER 16, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced an Advance Purchase Agreement with the government of New Zealand for the purchase of 10.7 million doses of NVX-CoV2373, Novavax’ candidate vaccine against COVID-19. About Novavax. Novavax, Inc.?(Nasdaq:

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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

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

JANUARY 21, 2021

Because the new COVID-19 vaccines should still work on these viral interlopers. Luckily, the new variants still rely on the coronavirus’ “spike protein” to infect cells, and the two COVID vaccines now on the U.S. FRIDAY, Jan. “The spike is really critical. “That process is done so efficiently by the [U.S.

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pharmaphorum

FEBRUARY 18, 2021

The South African coronavirus variant may cut the effectiveness of Pfizer/BioNTech’s vaccine by around two thirds, according to a laboratory study. Mutations may alter neutralisation by affecting spike function rather than antigen response and its also unclear from this study how the T-cell response is affected.

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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. Personalized medicine using genetic resequencing techniques, such as cell and gene therapies, enables researchers to create more customized therapies for combatting cancer.

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The Pharma Data

JANUARY 4, 2021

officials ramped up efforts to vaccinate more Americans, scientists around the world wrestled with whether it would make sense to delay the second doses everyone will need so more people can be vaccinated more quickly. Each vaccine would still be delivered in two doses given four weeks apart. MONDAY, Jan. 4, 2021 — As U.S.

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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

NOVEMBER 23, 2020

As the Pfizer-BioNTech COVID-19 vaccine is being evaluated by the U.S. Food and Drug Administration (FDA) and the Moderna vaccine is soon to follow, here’s a look at several of the top COVID-19 vaccine candidates and where they stand as of today. The prices for the vaccines are moving targets, dependent upon the amount ordered.

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