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

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). The 10-mg dose demonstrated an objective response in 40 percent of patients, with a median overall survival of 14.3

Clinical Trials 119

Clinical Trials Clinical Trials FDA Approval Trials 119

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

NOVEMBER 10, 2020

Phase1b/2 clinical study to be conducted in the United States and several European countries. This clinical study will evaluate the safety, tolerability, and clinical activity of escalating doses of orally administered capsules of Foralumab. Tiziana Life Sciences January 9, 2020 Press Release ( [link] ).

Life Science 40

Life Science Clinical Trials Clinical Trials Trials 40

The Pharma Data

JANUARY 3, 2021

. The scientific approaches underlying this clinical study could potentially be effective against SARs, MERS, and all variants of coronaviruses. This trial is the first to evaluate nasally administered Foralumab to improve the immune system’s fight against coronaviruses. About Tiziana Life Sciences.

Life Science 40

Life Science Clinical Trials Clinical Trials Antibody 40

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. Kaiser began Phase III trials of the vaccine at the end of July.

Vaccination 89

Vaccination Vaccine Trials Clinical Trials 89

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.

FDA Approval 111

FDA Approval Gene Therapy Clinical Trials Clinical Trials 111

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

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

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

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

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

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

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.

Protein 97

Protein Vaccination Vaccine Trials 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.

Vaccination 96

Vaccination Vaccine Development Clinical Trials 96

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 103

Vaccination Vaccine Development Life Science 103

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

The Pharma Data

NOVEMBER 1, 2020

Trial facilitated with coll a boration of Harvard Medical School and one of the world’s top Neurologist, Dr. Howard Weiner. Clinical Data Expected by End of Year. Tiziana Life Sciences plc. (“Tiziana” or the “Company”). . (“Tiziana” or the “Company”).

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Life Science 52

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, The inhalant version.

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Vaccination Vaccine Development Immune Response 126

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.

Development 64

Development Research Drugs Antibody 64

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.

Vaccination 75

Vaccination Vaccine Trials Clinical Trials 75

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.

Vaccination 105

Vaccination Vaccine Immune Response Trials 105

pharmaphorum

NOVEMBER 29, 2022

Number of on-going clinical trials: 14. T cells are known to mediate anti-tumor immune responses. For that reason, they have become the key target of immune checkpoint therapies, like PD-(L)1 agents. Locations: 3 (US HQ, Korea office, Korea R&D center). Number of employees: 90+ (as of Oct. Creation: Jan.

Clinical Trials 104

Clinical Trials Clinical Trials Trials Engineer 104

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

NOVEMBER 23, 2020

Severe cases of the infection did not occur among trial participants, nor were any hospitalizations reported. The global trials are assessing the safety and efficacy of the vaccine in individuals aged 18 years or over from diverse racial and geographic groups who are healthy or have stable underlying medical conditions.

Vaccination 97

Vaccination Vaccine Clinical Trials Clinical Trials 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

JANUARY 8, 2021

In the statement , the FDA said that it wants to “remind the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized by the FDA in order to safely receive the level of protection observed in the large randomized trials supporting their effectiveness.”.

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Vaccination Vaccine Clinical Trials Clinical Trials 144

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. Verifying the biomarker’s clinical validity for use as a surrogate endpoint in rare disease research is another hurdle which is generally a longer-term goal.

Trials 98

Trials Gene Hormones Clinical Trials 98

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. Proceeds will advance the clinical development of MinervaX’s novel GBS vaccine through phase 2 clinical trials, as well as manufacturing and regulatory preparation for phase 3.

Bacteria 52

Bacteria Vaccination Vaccine Immune Response 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.

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Manufacturing Vaccination Vaccine RNA 130

XTalks

JUNE 18, 2021

This is why Regeneron’s announcement of positive clinical trial results that show its antibody cocktail treatment can cut deaths among hospitalized patients is welcome news. It is the first trial to demonstrate that any antibody treatment could improve survival in patients hospitalized with COVID-19.

Antibody 75

Antibody Immune Response Trials Clinical Trials 75

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 102

Vaccination Vaccine Life Science Clinical Trials 102

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. The DIAGNODE-2 Trial.

Vaccination 103

Vaccination Vaccine Insulin Trials 103

XTalks

JANUARY 20, 2021

While diseases like celiac are associated with inappropriate activation of the immune system triggered by food antigens, this is not the case in IBS. In a normal, healthy intestine, foods do not trigger immune responses and so in a patient with IBS, something else must activate the response. Mouse and Human Studies.

Immune Response 52

Immune Response Research Allergies Protein 52

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