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 67

Immune Response Trials Vaccination Vaccine 67

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 Vaccination Vaccine Regulation 105

Drug Discovery World

JANUARY 17, 2023

Genoscience Pharma, a clinical-stage biotech company developing lysosomotropic drug candidates for the treatment of cancer, fibrosis and auto-immune diseases through autophagy modulation has launched the ABE-LIVER study, along with trial sponsor Grenoble University Hospital. . The trial . The primary criteria is PFS.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Development 52

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.

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

Drug Discovery World

AUGUST 3, 2023

It becomes the ninth Covid-19 vaccine to be authorised by the UK’s independent medicines regulator. The vaccine demonstrated a strong immune response, and the most common side effects were mild, and self-resolved within a few days of vaccination. Bimervax combines a part of the SARS-CoV-2 virus spike protein with an adjuvant.

Vaccination 52

Vaccination Vaccine Immune Response Medicine 52

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.

Vaccination 118

Vaccination Vaccine Immune Response Antibody 118

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 Vaccination Vaccine 98

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.

Vaccination 130

Vaccination Vaccine Regulation Immune Response 130

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.

Vaccination 52

Vaccination Vaccine Trials DNA 52

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 Vaccination Vaccine Immune Response 126

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 58

Trials Gene Silencing RNA Gene Expression 58

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.

Vaccination 118

Vaccination Vaccine Bacterium Protein 118

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

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

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.

Vaccination 105

Vaccination Vaccine 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 110

Immune Response Trials Clinical Trials Clinical Trials 110

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 Vaccination Vaccine 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).

Vaccination 89

Vaccination Vaccine Immune Response Regulation 89

Advarra

JANUARY 11, 2024

Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. Monoclonal Antibodies Monoclonal antibodies are lab-engineered immune system proteins.

Vaccination 52

Vaccination Vaccine Protein Antibody 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

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

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

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

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

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

Licensing 63

Licensing Licensing Immune Response Antibody 63

The Pharma Data

MAY 17, 2021

Sanofi and GlaxoSmithKline (GSK) have reemerged as COVID-19 vaccine contenders after their reformulated candidate delivered a strong immune response across all age groups in a phase 2 study. And if the results are positive, the companies expect to seek approval from regulators in the fourth quarter. 14, 2020 ). Jason Scott.

Vaccination 40

Vaccination Vaccine Immune Response RNA 40

pharmaphorum

APRIL 27, 2021

Following the success of the coronavirus vaccine developed with AstraZeneca, Oxford University’s Jenner Institute has unveiled trial results showing its experimental malaria shot could be around 77% effective.

Vaccination 52

Vaccination Vaccine Immune Response Trials 52

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 Vaccination Vaccine Antibody 105

pharmaphorum

MAY 18, 2021

Canadian biotech Medicago has the data it was hoping for from a phase 2 trial of its COVID-19 vaccine, partnered with GlaxoSmithKline, and is now hoping to have phase 3 data available “by early summer.” The purified vaccine is administered alongside GSK’s pandemic adjuvant to boost the immune response.

Immune Response 63

Immune Response Vaccination Vaccine Gene Sequencing 63

pharmaphorum

FEBRUARY 16, 2021

UK health chiefs have urged caution over any relaxation of lockdown rules amid signs that the impact of vaccination and social distancing regulations are beginning to work. The figures emerged as plans were announced to begin a new trial of the Oxford University/AstraZeneca vaccine in children.

Vaccination 58

Vaccination Vaccine Immune Response Trials 58

The Pharma Data

NOVEMBER 24, 2020

AstraZeneca’s COVID-19 vaccine candidate will undergo increased scrutiny by regulators because of the promising but confusing interim analysis results from a late-stage trial that found a one-and-a- half-dose regimen — given by mistake — was significantly more effective than a full double dose.

Immune Response 40

Immune Response Vaccination Vaccine Trials 40

pharmaphorum

OCTOBER 6, 2020

The announcement comes just days after the regulator said its CHMP scientific committee had begun to look at the first batch of data from AZ’s rival. In the case of a rolling review, the EMA evaluates trial data as they become available before a complete filing is submitted.

Vaccination 58

Vaccination Vaccine RNA Immune Response 58

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.

Vaccination 105

Vaccination Vaccine Development Life Science 105

pharmaphorum

AUGUST 31, 2021

As a top vaccine maker, GlaxoSmithKline has been a laggard in the COVID-19 vaccine race, but has put on a late burst of speed with a start of phase 3 trials of a second candidate that will be compared directly to the AstraZeneca shot. 1.351) strain first identified in South Africa.

Vaccination 58

Vaccination Vaccine Protein Immune Response 58

The Pharma Data

JUNE 17, 2022

In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

pharmaphorum

DECEMBER 1, 2021

BeyondSpring’s hopes of an early Christmas gift from the FDA were dashed today after the regulator said it was unable to approve the company’s lead drug plinabulin as a treatment for low white blood cell counts caused by cancer chemotherapy. of patients taking plinabulin plus pegfilgrastim and 13.6% of the pegfilgrastim-only arm.

Drugs 52

Drugs Immune Response Trials Clinical Trials 52

pharmaphorum

SEPTEMBER 7, 2022

The Swiss pharma group has agreed to buy Seattle-based biotech Good Therapeutics and its preclinical-stage PD-1-regulated IL-2 receptor agonist programme for $250 million upfront, with undisclosed milestone payments on offer tied to development, regulatory, and commercial objectives.

Immune Response 52

Immune Response Engineer Clinical Trials Clinical Trials 52