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).

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Development Production Immune Response Licensing 161

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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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

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Protein Vaccination Vaccine Immune Response 125

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 62

Licensing Licensing Immune Response Antibody 62

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 57

Trials Gene Silencing RNA Gene Expression 57

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

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.

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FDA Approval Vaccination Vaccine Antibody 104

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.

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Vaccination Vaccine Trials Clinical Trials 59

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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pharmaphorum

MARCH 28, 2022

GlaxoSmithKline and Vir’s Xevudy has become the latest COVID-19 antibody therapy to have its use restricted by the FDA as a result of waning activity against new variants of the virus. 2, and would be sharing these data with regulators around the world. 2 subvariant of Omicron. Previously, when the original BA.1

Antibody 52

Antibody Immune Response Regulation Sales 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

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 ). 2 infection.

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Vaccination Vaccine Immune Response RNA 40

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 62

Immune Response Vaccination Vaccine Gene Sequencing 62

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. The post Oxford’s malaria shot set for phase 3 test after ‘unprecedented’ 77% efficacy appeared first on.

Vaccination 52

Vaccination Vaccine Immune Response Trials 52

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.

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Vaccination Vaccine Protein Immune Response 57

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.

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Trials Gene Hormones Clinical Trials 98

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.

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Vaccination Vaccine RNA Immune Response 57

Find Me Cure

APRIL 23, 2020

This means that in order for herd immunity to work, 50-70% of the world population needs to get infected and then develop antibodies. . But another huge question mark here is if it’s even possible for people to become immune for long enough for this theory to even work. Thus, herd immunity wouldn’t work in this scenario.

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Immune Response Antibody Scientist Development 117

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

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

JANUARY 7, 2021

Used with widely available PET scan technology, ImaginAb’s technology allows doctors to track the T-cell immune response to cancer in real time and it has already picked up a multi-party deal involving Pfizer, AstraZeneca and Takeda.

Doctors 51

Doctors Doctor Immune Response Pharma Companies 51

The Pharma Data

NOVEMBER 10, 2020

First Ever Study with take-home capsules of Foralumab , a Fully Human Anti-CD3 Monoclonal Antibody. The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. Billion by 2025. and Europe.

Life Science 40

Life Science Clinical Trials Clinical Trials Trials 40

pharmaphorum

APRIL 6, 2021

According to Channel 4 news, two senior sources have said the regulator is being urged to offer other vaccines to younger people because of a possible link between the AZ jab and blood clots, in particular a rare condition known as cerebral venous sinus thrombosis (CVST). Valneva vaccine hits the mark in phase 1/2 trial.

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Vaccination Vaccine Immune Response Manufacturing 78

Delveinsight

FEBRUARY 11, 2021

Verily collaborates with Janssen to launch COVID-19 immune response study. Verily is partnering with Johnson & Johnson’s Janssen division to witness the body’s earliest immune responses to a coronavirus infection, with people participating in the research from within their homes. .

Gene Therapy 52

Gene Therapy Gene Immune Response In-Vivo 52

The Pharma Data

MARCH 8, 2021

The trial was conducted among 237 adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed while on or after previous platinum-based chemotherapy and PD-(L)1 inhibitor immunotherapy 4. Two Phase III CANOPY trials continue, evaluating canakinumab in first-line and adjuvant settings 2,3.

Trials 52

Trials Immune Response Clinical Trials Clinical Trials 52

Delveinsight

JANUARY 22, 2021

There are newer agents coming to the market, for instance, Fc receptor via monoclonal IgG antibodies mechanism, BTK [Bruton tyrosine kinase] inhibition, and so on, however, the real challenge lies in the compliance in terms of patients perspectives such as cost and tolerance.

Marketing 65

Marketing Drugs Antibody Compliance 65

XTalks

JULY 2, 2021

This is because the processes that maintain the uterine lining, including the placenta, during pregnancy are different than those that regulate the normal menstrual cycle. However, the similarity between the two proteins is not great enough for anti-spike antibodies to cross-react with placental syncytin-1.

Vaccination 105

Vaccination Vaccine Protein Immune Response 105

The Pharma Data

OCTOBER 19, 2020

Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies.

Vaccination 52

Vaccination Vaccine Immune Response Containment 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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Vaccination Vaccine Immune Response Protein 147

Delveinsight

SEPTEMBER 23, 2021

The biotech has evolved a T-cell receptor-like antibody to damage a selected immune checkpoint in oncology. Abexxa is forming molecules, which recruit immune cells zeroed in on particular tumor peptides. have helped prepare more than 20 drug candidates for clinical trials. Stafford and co.

RNA 61

RNA Gene Therapy Gene Protein 61

The Pharma Data

SEPTEMBER 9, 2020

“We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted.”. “As About the Phase 2/3 Study. billion doses by the end of 2021. billion doses by the end of 2021.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 3, 2021

Revenue growth was 12 percent when excluding effects of 2020 COVID-related stocking patterns, revenue from COVID-19 antibodies and recent business development. The trial compared tirzepatide to insulin glargine in adults with type 2 diabetes and increased cardiovascular risk. Loxo Oncology at Lilly and Kumquat Biosciences Inc.

Antibody 52

Antibody Sales Development Production 52

The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. CEO and Co-founder of BioNTech. “We

Licensing 52

Licensing Licensing Vaccination Vaccine 52

The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. , Outside the U.S.,

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Trials Production Sales Manufacturing 40

The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER. Outside the U.S.,

Trials 52

Trials Production Sales Manufacturing 52

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52