XTalks

APRIL 26, 2021

Related: After 18 Years, FDA Approves Malaria Prevention Drug. It is the world’s first and only licensed malaria vaccine and also the first licensed for use against a human parasitic disease of any kind. Moreover, a very strong immune response is needed to fend off the disease. Malaria Vaccine Phase II Trial.

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Pharmaceutical Technology

AUGUST 12, 2022

The concept behind this form of treatment is that the introduction of these cells will enhance the immune response to disease, often through bioengineering the immune cells to have improved functionality and characteristics, such as longer half-lives. There are also 19 drugs in preclinical development (Table 1).

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Development Drugs Immune Response Marketing 130

Pharmaceutical Technology

AUGUST 26, 2022

The drug was already approved for subcutaneous use in adults at risk of monkeypox or smallpox. A 2015 study showed that both routes of administration (ROA) produce similar immune responses but that intradermal ROA produced more swelling at the injection site.) See Table 1).

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Vaccination Vaccine Immune Response Manufacturing 130

The Pharma Data

JANUARY 6, 2021

a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. ImaginAb will receive license fees and payments for manufacturing and other support. LOS ANGELES , Jan. 7, 2021 /PRNewswire/ — ImaginAb Inc. , No other terms were disclosed.

Licensing 52

Licensing Licensing Clinical Trials Clinical Trials 52

pharmaphorum

AUGUST 16, 2020

ChAdOx1 – which is in large-scale phase 2/3 trials – was licensed by AZ in April and renamed AZD1222, and should be ready for first deliveries before the end of the year. It will be provided on a no-profit basis while the pandemic is ongoing.

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pharmaphorum

NOVEMBER 30, 2020

Genmab has axed development of its pipeline cancer drug enapotamab vedotin after it failed to show enough activity in a proof-of-concept trial. Genmab said it will not advance development of the drug after data from expansion cohorts showed it did not meet stringent criteria for proof-of-concept in the early trial.

Development 52

Development Drugs Antibody Immune Response 52

The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

Antibody 52

Antibody Licensing Licensing Development 52

pharmaphorum

DECEMBER 6, 2022

Moderna claims that Comirnaty infringes its patents covering a chemical modification to prevent an unwanted immune response in patients and allow larger doses to be delivered, as well as a proprietary lipid nanoparticle formulation. The post Pfizer/BioNTech strike back in Moderna COVID vaccine lawsuit appeared first on.

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pharmaphorum

AUGUST 24, 2020

With the ink barely dry on a deal to develop Dragonfly’s lead cancer immunotherapy, Bristol-Myers Squibb’s business development team has agreed to buy Canadian biotech Forbius and its pipeline of drugs for cancer and fibrotic diseases. BMS seems to be interested mainly in AVID200’s potential in cancer, however, at least initially.

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Immune Response Antibody Drugs Development 59

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.

Drugs 52

Drugs Immune Response Trials Clinical Trials 52

The Pharma Data

DECEMBER 17, 2020

Merck will select cancer targets and harness Janux’s proprietary Tumor Activated T Cell Engager (TRACTr) technology to engineer novel, T cell engager drug candidates. Janux technology can be applied to immunotherapies that target all three stages of an anti-tumor immune response. Janux, in exchange, will receive up to $500.5

Immune Response 52

Immune Response Engineer Development Licensing 52

XTalks

MAY 1, 2023

Last week, the US Food and Drug Administration (FDA) granted accelerated approval to Biogen’s Qalsody (tofersen) for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 ( SOD1 ) gene. This makes Qalsody the first approved treatment to target a genetic cause of ALS.

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FDA Approval Gene Genetics Protein 89

pharmaphorum

SEPTEMBER 23, 2021

Imperial’s candidate was nevertheless the first saRNA drug to be advanced into human clinical testing, and when the results were reported earlier this year revealed that it effectively stimulated an immune response, providing proof-of-concept for the approach.

RNA 52

RNA Immune Response Vaccine Vaccination 52

The Pharma Data

APRIL 8, 2022

Now, new research from the Wyss Institute at Harvard University has revealed that this constant pattern of stretching and relaxing does even more – it generates immune responses against invading viruses. a Wyss Technology Development Fellow at the Institute. ” The results are published today in Nature Communications.

Immune Response 52

Immune Response In-Vivo Genetic Analysis Research 52

The Pharma Data

JANUARY 12, 2021

Biond Biologics announced today that it has entered into a potentially $1 billion global licensing agreement with Sanofi to take a joint stab at defeating advanced forms of cancer with a more comprehensive and expedited approach to immuno-oncology. . Co-Founder and Chief Executive Officer at Biond.

Immune Response 52

Immune Response Clinical Trials Clinical Trials Development 52

XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

Drugs 52

Drugs FDA Approval Sales Vaccine 52

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.

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pharmaphorum

AUGUST 27, 2020

Regulatory pressures, lengthy drug development times, and the fact that drug prices have become politicised have raised risks and cut revenue projections, leading to the biotech sector falling out of fashion. Conventional vaccines introduce an inactivated sample of a disease to patients with the aim of stimulating an immune response.

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pharmaphorum

JUNE 24, 2022

It also developed the first single-dose drug therapy that can be used to eradicate malaria caused by Plasmodium vivax – tafenoquine – and is working on an improved TB vaccine which has been licensed to the Bill & Melinda Gates Foundation. The new unit will operate on a non-profit basis, said GSK in a statement.

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Vaccine Vaccination Immune Response Development 59

pharmaphorum

DECEMBER 21, 2020

The headline of the deal was an experimental COVID-19 drug, but it also claimed rights to a pipeline of early-stage oncology drugs. billion alliance with Taiho and Astex for cancer antibodies, including a KRAS drug, and a $4.2 Other recent deals include a $2.8 Other recent deals include a $2.8

Immune Response 59

Immune Response Sales Antibody Drugs 59

pharmaphorum

JANUARY 7, 2021

The California-based company has signed a non-exclusive license with Pfizer to supply its 89Zr CD8 Immuno-PET agent, which can be used to image CD8 T cells in cancer patients. The technology) allows them to make decisions quicker and allows them to triage their drugs more quickly in the clinical phase.”.

Immune Response 53

Immune Response Doctor Doctors Pharma Companies 53

The Pharma Data

OCTOBER 26, 2020

Food and Drug Administration greenlit the restart of AstraZeneca’s Phase III COVID-19 vaccine trial, the U.K.-based based company said the preventative medication boosts immune responses in older and younger adults against the novel coronavirus. The approval marks the first drug approved by the U.S.

Antibody 52

Antibody Vaccine Vaccination Manufacturing 52

pharmaphorum

JANUARY 4, 2023

The hypothesis is that it will induce immune tolerance by stimulating anti-inflammatory regulatory T- (Treg) cells and cytokines that dampen down the immune response. Gilead is collaborating with EVOQ on preclinical-stage projects, and has taken an option to exclusively license rights if they live up to their early promise.

Immune Response 52

Immune Response Engineer Licensing Licensing 52

pharmaphorum

NOVEMBER 2, 2022

CSL’s vaccines unit CSL Seqirus division is paying Arcturus $200 million upfront to gain access to its self-amplifying mRNA technology platform and exclusive licenses to several vaccine candidates, with another $4.3 billion on offer in milestones if the programmes meet development and commercial objectives.

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Vaccination Vaccine Immune Response Gene Therapy 52

pharmaphorum

FEBRUARY 8, 2022

He said elevated transaminase levels can rise after the administration of gene therapies as a result of the immune response to the viral vector used to deliver the sequence, and steroids are generally used to reduce this response to improve uptake into cells.

Gene Therapy 52

Gene Therapy Gene Immune Response Licensing 52

Delveinsight

JANUARY 21, 2021

Drugs that target the cancer-promoting proteins MDM2 and BET have been attempted in acute myeloid leukaemia (AML) and have not been all that effective on their own. The new research provides a scientific rationale to advance clinical studies of the drug combination in patients with AML. billion in total for three drugs.

Research 52

Research Protein Clinical Trials Clinical Trials 52

pharmaphorum

AUGUST 26, 2022

Among the claims is that Comirnaty was developed using a chemical modification to prevent causing an unwanted immune response in patients which was discovered by Moderna scientists, and that the use of a lipid nanoparticle formulation also infringes its intellectual property.

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Vaccination Vaccine Sales Immune Response 59

The Pharma Data

JANUARY 17, 2021

Food and Drug Administration (FDA) are starting to pick up. The drug is being developed for several indications, but the NDA is for lupus nephritis (LN), a serious inflammation of the kidneys the result of systemic lupus erythematosus (SLE). Sarah Silbiger/Getty Images. After a start-of-the-year lull, activities at the U.S.

Manufacturing 52

Manufacturing Immune Response Allergies Drugs 52

XTalks

SEPTEMBER 5, 2023

Investigation of the possibility of VAED is crucial during clinical trials for decision-making on vaccine licensing by regulatory agencies. Finally, addressing the time-consuming and costly transition from non-clinical to clinical development due to difficulties in predicting human immune responses is another issue.

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Vaccine Vaccination Development Clinical Trials 96

XTalks

JUNE 21, 2024

Dr. Bryan began his career at Schering-Plough, engaging in formulation and drug delivery. Unlike traditional therapies that act on the immune cascade after it has been initiated, Revolo’s treatments act at the very beginning of the immune response.

Development 52

Development Immune Response Drugs Regulation 52

The Pharma Data

JANUARY 17, 2021

a global leader in providing drug discovery animal model solutions, announces an expansion of its immuno-oncology portfolio. . Immuno-oncology is a leading research priority because it uses the body’s own immune system to effectively treat some types of cancer. RENSSELAER, N.Y., About Taconic Biosciences, Inc.

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Genetic Engineering Genetics Engineer Immune Response 40

pharmaphorum

JANUARY 8, 2021

This means that the vaccine is not being delivered as licensed. I DID NOT consent to receive an off-label drug with NO evidence of benefit with a single dose. The Oxford-AstraZeneca vaccine trial did include difference spacing between doses and showed longer gaps (two to three months) yielded a greater immune response.

Vaccination 59

Vaccination Vaccine Immune Response Trials 59

pharmaphorum

JANUARY 8, 2021

This means that the vaccine is not being delivered as licensed. I DID NOT consent to receive an off-label drug with NO evidence of benefit with a single dose. The Oxford-AstraZeneca vaccine trial did include difference spacing between doses and showed longer gaps (two to three months) yielded a greater immune response.

Vaccination 59

Vaccination Vaccine Immune Response Trials 59

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. TICOVAC may help reduce the risk of TBE for people traveling to endemic areas, potentially including military personnel serving in these locations.

FDA Approval 52

FDA Approval Vaccination Vaccine Containment 52

The Pharma Data

JANUARY 22, 2021

As research developments into RNA vaccines help scientists accelerate drug candidates to arm the immune system against coronavirus, Pharma IQ ’s Keeping tabs on Covid-19 update returns with news from some of the biotechnology innovators leading the fight against the global pandemic.

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Vaccine Vaccination Protein Immune Response 52

XTalks

SEPTEMBER 17, 2020

Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012. For example, studies of heart attack prevention medications use the surrogate endpoint of low-density lipoprotein cholesterol (LDL-C) to assess the effectiveness of new drugs. What Is a Surrogate Endpoint?

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Trials Gene Hormones Clinical Trials 98

The Pharma Data

JANUARY 31, 2021

Delivery of viral antigens in potent vaccine vectors to elicit a strong immune response is a cornerstone of successful infectious disease vaccines,” said Karin Jooss, PhD, Executive Vice President of Research and Chief Scientific Officer of Gritstone. This press release features multimedia.

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Vaccination Vaccine Clinical Trials Clinical Trials 52