pharmaphorum

SEPTEMBER 24, 2020

The UK could be the first country to carry out a COVID-19 “challenge trial” where healthy volunteers are deliberately infected with coronavirus to test vaccines, according to press reports. That vaccine is top of the World Health Organization’s list of vaccines in clinical development, which shows there are 38 potential shots in human trials.

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Vaccine Vaccination Trials Immune Response 98

pharmaphorum

FEBRUARY 22, 2021

In December interim phase 1/2 trial results showed the vaccine produced a lower immune response in older adults. The vaccine is based around an adjuvanted recombinant protein, which will be tested in a new phase 2 study to assess the response including in older adults.

Vaccine 89

Vaccine Vaccination Recombinant DNA Technology Trials 89

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

Pharmaceutical Technology

JANUARY 19, 2023

The expanded manufacturing and marketing approval was based on the data obtained from the Phase II trial, conducted in Australia and the US; a separate Phase II trial held in South Africa; and the UK-sponsored COV-BOOST trial. It has been developed using the company’s recombinant nanoparticle technology.

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Vaccine Vaccination Immune Response Protein 147

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. The timetable for approval from the FDA depends on whether the regulator accepts data from the company’s trial in the UK, which could set up a potential Emergency Use Authorisation.

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Vaccine Vaccination Regulation Immune Response 130

pharmaphorum

NOVEMBER 19, 2020

The coronavirus vaccine being developed by Oxford University and AstraZeneca produces a strong immune response in higher risk older patients, a study has found. Although both vaccines are not yet approved by regulators, the results are encouraging as older people seem to be most at risk from the virus.

Immune Response 105

Immune Response Vaccine Vaccination Regulation 105

pharmaphorum

JANUARY 15, 2021

J&J has announced early trial results that suggest its single-shot coronavirus vaccine provides a sustained response against the virus ahead of a phase 3 trial readout due later this month. J&J expects to file with the FDA first, followed by other regulators.

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Vaccine Vaccination Immune Response Antibody 119

pharmaphorum

JANUARY 6, 2023

The cancer immunotherapies will mainly be provided in the context of clinical trials over the alliance, which extends out to 2030, but also covers supply of commercial therapies if approved in the interim. The post UK partners with BioNTech on clinical trials of mRNA cancer therapies appeared first on.

Clinical Trials 111

Clinical Trials Clinical Trials Trials Vaccine 111

pharmaphorum

DECEMBER 11, 2020

Interim results from a phase 1/2 clinical trial show the immune response from Sanofi/GSK’s vaccine produced a lower immune response in older adults. While antibody levels were comparable to those seen in recovering COVID-19 patients in adults aged 18-49, the response was lower in older adults.

Immune Response 72

Immune Response Trials Vaccine Vaccination 72

XTalks

NOVEMBER 12, 2024

For example, recent clinical trials and regulatory approvals for RSV vaccines are notable milestones that indicate advancements in preventing viral pneumonia in both children and elderly adults. These therapies work by controlling excessive inflammatory responses in the lungs.

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Bacteria Life Science Vaccine Vaccination 110

Worldwide Clinical Trials

JUNE 21, 2024

Worldwide Clinical Trials attends each year to hear from the research community, connect with our sponsors and sites, and explore potential partnerships to drive forward novel treatments. Check out this webinar on navigating the landscape of oncology clinical trials. Interested in hearing more insights from Matt?

Antibody 162

Antibody Clinical Trials Clinical Trials In-Vitro 162

pharmaphorum

DECEMBER 4, 2020

Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter of 2021. VLA15 has demonstrated a promising immune response and safety data in pre-clinical and clinical studies so far.

Vaccine 119

Vaccine Vaccination Bacterium Protein 119

pharmaphorum

JANUARY 5, 2022

A COVID-19 vaccine that could work against multiple variants of the coronavirus – developed by US biotech Gritstone bio – has generated encouraging immune response data in its first clinical trial. “With new variants – like Omicron and B.1.640.2

Protein 126

Protein Vaccine Vaccination Immune Response 126

Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. Expanded access to experimental biologics. BLA process (CBER).

Development 161

Development Production Immune Response Licensing 161

STAT News

OCTOBER 19, 2022

1 subvariant of Omicron generated a strong immune response against that variant, with antibody levels staying high for at least three months , Reuters notes. Omicron-tailored  Omicron-tailored shots by Pfizer and Moderna are already authorized by regulators in several countries. 5 subvariants of Omicron.

Immune Response 98

Immune Response Scientist Vaccine Vaccination 98

pharmaphorum

MARCH 17, 2021

The big UK pharma will be hoping that a partnership with the Canadian biotech Medicago will run more smoothly as a trial of the plant-based vaccine enters its late stage. The companies said phase 3 testing of the vaccine in combination with GSK’s adjuvant has begun after Canadian and US regulators gave the green light.

Vaccine 105

Vaccine Vaccination Immune Response Trials 105

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.

Vaccine 105

Vaccine Vaccination Immune Response Trials 105

pharmaphorum

APRIL 22, 2022

Ampio Pharma’s candidate therapy for knee osteoarthritis has been knocked back by the FDA, which will likely now require a new clinical trial of the drug before it will consider a review. The question now is whether Ampio has the resources on hand to run a new study without raising additional funding.

Immune Response 111

Immune Response Trials Clinical Trials Clinical Trials 111

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.

Vaccine 52

Vaccine Vaccination Trials Immune Response 52

pharmaphorum

FEBRUARY 8, 2021

China’s national regulator has approved Sinovac Biotech’s COVID-19 vaccine for use by the general public. Brazilian clinical trial results published last month showed the vaccine, dubbed Coronavac, is just over 50% effective. This is the second vaccine approved by China’s National Medical Products Administration (NMPA).

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Vaccine Vaccination Immune Response Regulation 90

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. Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012.

Trials 98

Trials Gene Hormones Clinical Trials 98

pharmaphorum

SEPTEMBER 29, 2020

The US drugs regulator has placed the phase 2/3 trial of INO-4800 on partial clinical hold while it seeks answers from the company about the DNA-based vaccine as well as the device used to deliver the shot to patients in the study. An expanded phase 1 trial of the shot is still ongoing and unaffected by the partial hold.

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Vaccine Vaccination Trials DNA 52

The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune responses were similar across the age groups studied, including older adults.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccine Vaccination 52

pharmaphorum

SEPTEMBER 25, 2020

Leap Therapeutics will get a swift FDA review for its lead drug DKN-01 for a form of gastric and gastroesophageal junction (G/GEJ) cancer after being awarded fast-track status by the regulator. In animal models, neutralising DKK1 has been shown to activate an innate immune response against malignant cells.

Immune Response 72

Immune Response Trials Drugs Containment 72

pharmaphorum

AUGUST 16, 2021

The two companies have submitted data from a phase 1 trial in support of the booster dose to the US regulator, and will follow that with filings in Europe and elsewhere in the world in the coming weeks.

FDA Approval 105

FDA Approval Vaccine Vaccination Antibody 105

pharmaphorum

FEBRUARY 9, 2021

million ($22 million) in second-round financing as it prepares to start clinical trials of its lead drug candidate INT-1B3 for solid tumours. The start of dosing in the phase 1/1b trial of the drug has been delayed by the COVID-19 pandemic, but recruitment of the target 80 participants with advanced solid tumours is reported to be ongoing.

Trials 59

Trials Gene Silencing RNA Gene Expression 59

Find Me Cure

APRIL 23, 2020

For example, if you become immune but this immunity only lasts for a few weeks, this is not long enough to allow for a good proportion of the population to become infected and then immune as well. Thus, herd immunity wouldn’t work in this scenario. Enter ‘Covid-19′ and start searching. .

Immune Response 117

Immune Response Antibody Scientist Development 117

pharmaphorum

MARCH 4, 2021

Sunak pledged £28 million towards the UK’s capacity for vaccine testing, support for clinical trials and to improve the ability to acquire samples of new COVID-19 variants. The guidance comes from the ACCESS Consortium of regulators from the UK, Australia, Canada, Singapore and Switzerland.

Vaccine 105

Vaccine Vaccination Development Life Science 105

pharmaphorum

DECEMBER 14, 2020

Armed with new data from a randomised clinical trial, one company is hoping to change that mindset. The company is FriendsLearn – based in India and with an R&D office in San Francisco – which recently reported results from a trial showing that its fooya! In fooya!,

Clinical Trials 111

Clinical Trials Clinical Trials Immune Response Trials 111

pharmaphorum

JULY 9, 2021

With the COVID-19 delta variant has become the dominant strain circulating in the US, Pfizer and BioNTech have said they will ask the FDA and other regulators to approve a third dose of their Comirnaty vaccine to guard against a winter surge in cases. .

Vaccine 98

Vaccine Vaccination Antibody Immune Response 98

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.

Vaccine 59

Vaccine Vaccination Trials Clinical Trials 59

pharmaphorum

FEBRUARY 18, 2021

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. The body’s immune response to the coronavirus is not limited to antibodies with CD8+ T-cells also playing roll combating infections.

Immune Response 52

Immune Response Genetic Engineering Vaccine Vaccination 52

The Pharma Data

OCTOBER 23, 2020

A solidarity clinical trial “is one of the largest international randomized trials for Covid-19 treatments, enrolling almost 12,000 patients in 500 hospital sites in over 30 countries”, according to the World Health Organization (WHO), which launched the trail with a number of partners.

Trials 52

Trials Immune Response Clinical Trials Clinical Trials 52

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

APRIL 14, 2022

billion alliance with Genmab to find new cancer therapies, AbbVie has said it is ready to start talking to regulators about filing for approval of the lead drug in the partnership – epcoritamab for large B-cell lymphoma (LBCL). Two years after signing a $3.9 Analysts at Jefferies have previously said they think epcoritamab could become a $1.5

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Licensing Licensing Immune Response Antibody 64

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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Vaccine Vaccination Development Clinical Trials 96

The Pharma Data

MARCH 25, 2021

today announced primary results from the Phase 2/3 RELATIVITY-047 (CA224-047) trial evaluating the fixed-dose combination of relatlimab, an anti-LAG-3 antibody, and Opdivo (nivolumab) versus Opdivo alone in patients with previously untreated metastatic or unresectable melanoma. About RELATIVITY-047 (CA224-047). Source link:[link].

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52