Drug Discovery World

MARCH 30, 2023

Likang Life Sciences has been granted implied approval by China’s National Medical Products Administration (NMPA) for the clinical trial of its innovative personalised neoantigen-targeted vaccine LK101 Injection for advanced solid tumours. Hence, there is a need to increase clinical investigations in this promising area.”

Regulation 52

Regulation Vaccination Vaccine Trials 52

XTalks

MAY 4, 2023

However, there are ongoing clinical trials for celiac disease to investigate potential new treatments. Some of the approaches being studied include: Enzyme therapy: Researchers are testing enzymes that may help break down gluten in the digestive system, reducing the risk of immune system activation and damage to the small intestine.

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Clinical Trials Clinical Trials Trials Immune Response 98

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. COVID-19 Clinical Trials.

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Clinical Trials Clinical Trials Vaccination Vaccine 75

The Pharma Data

NOVEMBER 10, 2020

The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. Weiner, chairman of the scientific advisory board of Tiziana Life Sciences, commented: “We understand that this will be the first-ever study with ‘take-home’ capsules of any mAb for immunotherapies for human diseases. Billion by 2025.

Life Science 40

Life Science Clinical Trials Clinical Trials Trials 40

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

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. The last patients in the trial received their final dose on 21 December 2020. The topline data from the trial is expected to be available in January 2021. About Tiziana Life Sciences.

Life Science 40

Life Science Clinical Trials Clinical Trials Antibody 40

XTalks

AUGUST 13, 2020

and BioNTech’s lead vaccine candidate in a Phase III trial being conducted at sites in California and Oregon. The company announced that it commenced the Phase III clinical trial to evaluate the investigational COVID-19 vaccine this week. Related: Pfizer and BioNTech’s COVID-19 Vaccine Shows Positive Early Trial Results.

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Vaccination Vaccine Trials Clinical Trials 89

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

MAY 17, 2024

This pursuit has seen various high-profile failures, such as Merck’s STEP trial in 2007, which was halted early when it failed to prevent HIV infection and, unexpectedly, appeared to increase the risk in some individuals. As a result, further vaccinations within the trial were halted.

Vaccination 52

Vaccination Vaccine Research Immune Response 52

XTalks

AUGUST 8, 2022

Medicxi is a prominent international life sciences investment firm that invested in over 60 portfolio companies such as Versanis Bio, Rivus Pharmaceuticals, Capella Bioscience and more. One of Medicxi’s portfolio companies called MiroBio is set to be acquired by Gilead Sciences for approximately $405 million in cash.

Immune Response 98

Immune Response Antibody Life Science Engineer 98

pharmaphorum

JULY 18, 2022

Convidencia’s injectable version was granted World Health Organization (WHO) Emergency Use Listing (EUL), and its inhalant counterpart, currently in phase three clinical trials, has shown enormous promise. CanSinoBIO’s inhalant has finished phase three trials in China and is presently undergoing trials in several countries.

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Vaccination Vaccine Development Immune Response 136

XTalks

DECEMBER 29, 2023

Tarlatamab is an investigational drug currently undergoing clinical trials to assess its efficacy in patients with two distinct types of neuroendocrine cancer: SCLC and neuroendocrine prostate cancer (NEPC). Results demonstrated significant antitumor activity, durable objective responses and encouraging survival rates in these patients.

Clinical Trials 119

Clinical Trials Clinical Trials FDA Approval Trials 119

XTalks

MAY 7, 2021

Novavax published the latest results from a Phase IIb clinical trial conducted in South Africa evaluating the safety and efficacy of NVX-CoV2373, appearing in the NEJM ’s May 6, 2021 issue. Earlier results from a more complete analysis of trial data shared in March confirmed a high level efficacy of 86.3 1.351 variant. 1.351 variant.

Protein 97

Protein Vaccination Vaccine Trials 97

XTalks

MARCH 13, 2023

The US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) held a recent town hall where three experts from the regulator provided guidance on how to design and conduct gene therapy clinical trials for rare diseases.

Gene Therapy 52

Gene Therapy Clinical Trials Clinical Trials Gene 52

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. A scheme providing £500 payments to people self-isolating has been extended in England until the summer.

Vaccination 104

Vaccination Vaccine Development Life Science 104

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. The Phase I trial for HB-500 is scheduled to start in the first half of 2024.

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FDA Approval Gene Therapy Clinical Trials Clinical Trials 111

Drug Discovery World

JANUARY 31, 2023

Proceeds will support the continued development of the company’s first-of-its-kind immuno-oncology approaches designed to overcome key resistance mechanisms through the creation of novel cancer antigens. This includes the advancement of the company’s lead asset, GRWD5769, into a Phase I/II clinical trial in the first half of 2023. Grey Wolf Therapeutics’ (..)

Immune Response 52

Immune Response Clinical Trials Clinical Trials Life Science 52

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. Malaria Vaccine Phase II Trial.

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Vaccination Vaccine Immune Response Trials 105

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 ongoing Phase III trial continues to evaluate the mRNA vaccine in close to 44,000 individuals.

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Vaccination Vaccine Trials Clinical Trials 75

XTalks

OCTOBER 12, 2021

The vaccine was tested in rats and showed strong, immediate and long-lasting immune responses to confer protection against the disease. is an autoantigen, which means it is an endogenous antigen that triggers an immune response in the body. as a potential trigger for rheumatoid arthritis.

Vaccination 105

Vaccination Vaccine Research Immune Response 105

XTalks

AUGUST 14, 2023

XTALKS WEBINAR: Cancer Immunotherapy: Exploring Imaging as a Catalyst to Immune Response Prediction Live and On-Demand: Wednesday, September 27, 2023, at 2pm EDT (11am PDT) Register for this free webinar to discover the present and transformative impact of predictive biomarkers on immunotherapy response.

FDA Approval 97

FDA Approval Antibody Immune Response Drugs 97

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

XTalks

JUNE 15, 2022

Adjuvants can help boost the effectiveness of a vaccine and elicit a stronger immune response. Clinical Trial Results. This trial included nearly 30,000 adults across over 100 sites in the US and Mexico. Compared to adults, immune responses were approximately two- to three-fold higher in adolescents.

Vaccination 59

Vaccination Vaccine Immune Response Protein 59

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

SEPTEMBER 17, 2020

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. IGF-1 is an acceptable surrogate endpoint in trials of growth hormone receptor agonists like Somavert, and is preferred for pediatric patient populations.

Trials 98

Trials Gene Hormones Clinical Trials 98

Drug Discovery World

FEBRUARY 28, 2024

Using IgE to treat cancer In the UK, a Cancer Research UK-funded clinical trial has shown, for the first time, that a new class of antibody could benefit cancer patients whose existing treatments have stopped working. She has over 25 years’ experience in B2B journalism, ten of those being in life sciences.

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Development Research Drugs Antibody 64

XTalks

JULY 28, 2021

While Merck’s previous shot, Pneumovax 23, defends against 23 serotypes and has been on the market for almost four decades, the immune responses it generates are not as durable as Prevnar 13. The vaccine is currently being tested in children in Phase III trials and the company is hoping to get FDA approval by the end of the year.

FDA Approval 89

FDA Approval Vaccination Vaccine Immune Response 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. Mixed Results.

Vaccination 98

Vaccination Vaccine Immune Response Antibody 98

XTalks

JUNE 9, 2022

Doortje Reijman, trial investigator and research associate in Pediatric Metabolic Diseases and Nephrology at the Amsterdam University Medical Center. These antibodies bind strongly to their target and provide a robust immune response. How does Evkeeza Lower Cholesterol Levels? Ongoing and Future Studies.

Trials 52

Trials Antibody Genetics Gene 52

Pharmaceutical Technology

NOVEMBER 22, 2022

The mission was first put forward during the UK’s G7 Presidency of June 2021, with support from representatives of the life sciences industry. billion towards the “pandemic-busting plan”, which involves the investigation of rapid response vaccine technologies. The UK Government is behind this effort.

Manufacturing 130

Manufacturing Vaccination Vaccine RNA 130

XTalks

JUNE 24, 2022

Moderna’s data came from two ongoing, randomized, blinded, placebo-controlled trials being conducted in the US and Canada, which includes infants, children and adolescents. Immune responses after receiving the Pfizer or Moderna vaccines in children six to 11 years of age were also comparable to older individuals.

Vaccination 98

Vaccination Vaccine Immune Response Trials 98

XTalks

JULY 26, 2023

Efficacy and Safety of Vanflyta Vanflyta’s FDA approval was based on results of the QuANTUM-First trial published in The Lancet.

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FDA Approval Immune Response Drugs Trials 98

XTalks

MAY 24, 2024

The approval is based on the overall response rate and duration of response observed in the DeLLphi-301 study , with continued approval depending on the demonstration of clinical benefit in a future confirmatory trial(s). The study’s effectiveness was measured by how many patients saw their cancer shrink and for how long.

Antibody 52

Antibody Clinical Trials Clinical Trials Trials 52

XTalks

MARCH 19, 2024

These cells are crucial for the body’s immune response, producing antibodies that help fight infection. However, when these cells become cancerous, they proliferate uncontrollably, leading to a myriad of health issues, including bone damage, kidney failure and impaired immune function.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Immune Response 59

XTalks

NOVEMBER 22, 2022

In clinical trials, the treatment delayed stage 3 disease onset for about two years compared with the placebo. Tzield’s FDA approval was based on safety and efficacy data from a randomized, double-blind, event-driven, placebo-controlled trial involving 76 patients with stage 2 type 1 diabetes.

Insulin 97

Insulin Drugs FDA Approval Immune Response 97

XTalks

SEPTEMBER 5, 2023

Investigation of the possibility of VAED is crucial during clinical trials for decision-making on vaccine licensing by regulatory agencies. In the majority of cases, the risk of VAED is brought to light during preclinical stages or early clinical trial phases. However, guidelines do not provide matters specific to each vaccine type.

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Vaccination Vaccine Development Clinical Trials 96