XTalks

DECEMBER 30, 2024

has announced promising Phase IIb results for cenerimod, an investigational drug targeting immune system dysfunction in moderate-to-severe systemic lupus erythematosus (SLE). SLE is an autoimmune disease where the immune system attacks healthy tissues, causing inflammation, pain and potential organ damage. Viatris Inc.

Immune Response 52

Immune Response Gene Expression Drugs Trials 52

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.

Clinical Trials 75

Clinical Trials Clinical Trials Vaccination Vaccine 75

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.

Vaccination 138

Vaccination Vaccine Development Immune Response 138

XTalks

DECEMBER 20, 2024

Steqeyma was evaluated through a comprehensive set of studies, including a Phase III trial that showed that the biosimilar met the primary endpoint of improved Psoriasis Area and Severity Index (PASI) scores by Week 12 and sustained results through Week 28. billion by 2034, driven by an 11.2 percent compound annual growth rate (CAGR).

FDA Approval 52

FDA Approval Immune Response Antibody Marketing 52

XTalks

SEPTEMBER 29, 2021

The episode also features a discussion about Pfizer and BioNTech’s announcement of the first trial results for their COVID-19 vaccine in young children five to 11 years of age. The data shows that the vaccine is safe, well-tolerated and elicits robust immune responses in this age group.

Life Science 52

Life Science Vaccination Vaccine Immune Response 52

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.

Vaccination 89

Vaccination Vaccine Trials Clinical Trials 89

XTalks

NOVEMBER 3, 2021

The authorization was based on trial data that showed the vaccine was safe, well-tolerated and induced robust immune responses among children in this age group; side effects were generally mild to moderate. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Life Science 52

Life Science Drug Delivery Systems Vaccination Vaccine 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 105

Vaccination Vaccine Development Life Science 105

XTalks

JANUARY 20, 2025

Pfizer announced promising results from its Phase III trial investigating the efficacy of sasanlimab, an anti-PD-1 monoclonal antibody, in combination with standard of care Bacillus Calmette-Guerin (BCG) immunotherapy for patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are BCG-nave.

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

XTalks

JANUARY 20, 2025

Pfizer announced promising results from its Phase III trial investigating the efficacy of sasanlimab, an anti-PD-1 monoclonal antibody, in combination with standard of care Bacillus Calmette-Guerin (BCG) immunotherapy for patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are BCG-nave.

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

XTalks

FEBRUARY 19, 2024

The study compared the immune responses evoked by Moderna’s mRNA vaccine to those generated by a previous vaccine candidate, namely, the MF59-adjuvanted glycoprotein B (gB) proten subunit vaccine (gB/MF59) developed by Sanofi. During pregnancy, CMV infection is responsible for causing severe birth defects and brain damage in newborns.

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

XTalks

DECEMBER 15, 2021

The team also talked about results from an early-stage trial evaluating Moderna’s new mRNA-based influenza vaccine in adults. The results showed that the vaccine had no serious safety concerns and elicits immune responses against four different strains of the influenza virus.

Life Science 40

Life Science FDA Approval Vaccination Vaccine 40

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

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.”.

Vaccination 144

Vaccination Vaccine Clinical Trials Clinical Trials 144

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

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

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

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

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

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

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

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

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

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

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

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

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

pharmaphorum

MARCH 23, 2021

The Cambridge, Massachusetts-based company is currently testing belzupacap sarotalocan (AU-011) in a phase 2 trial involving patients with choroidal melanoma, a tumour that develops in the back of the eye that can cause vision loss and is almost invariably fatal if it spreads to other parts of the body.

Development 71

Development Drugs Immune Response Life Science 71

XTalks

JULY 31, 2024

Alopecia areata can be triggered by genetics, immune system dysfunction and environmental factors. Leqselvi works by selectively inhibiting the Janus kinases (JAK) JAK1 and JAK2, pathways that play a key role in this misguided immune response.

Immune Response 105

Immune Response Dermatology Clinical Trials Clinical Trials 105

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.

Vaccination 96

Vaccination Vaccine Development Clinical Trials 96

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

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 Gene Clinical Trials Clinical Trials 52

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 105

Clinical Trials Clinical Trials Trials Engineer 105

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. Pfizer Inc.

Vaccination 98

Vaccination Vaccine Trials Antibody 98

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

XTalks

MAY 30, 2023

Novel treatments: Ongoing research into new treatments for MS include novel immunomodulatory drugs that aim to modulate or suppress the immune response that attacks the myelin sheath in MS. Sanofi’s BTK inhibitor tolebrutinib is currently under a partial FDA clinical hold after reports of liver injury in Phase III trials.

Genetics 98

Genetics Research Immune Response Drugs 98