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.

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Drugs Immune Response Trials Clinical Trials 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

In March, once the worst of the crisis was passed and COVID-19 vaccines entered regular commercial trade with producers competing for the booster shot market, Moderna said it was time to update its pledge and start to enforce its IP rights. The post Pfizer/BioNTech strike back in Moderna COVID vaccine lawsuit appeared first on.

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Vaccination Vaccine Immune Response Sales 97

The Pharma Data

MAY 7, 2021

BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (together with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

Licensing 52

Licensing Licensing Vaccination Vaccine 52

Drug Discovery World

APRIL 20, 2023

Dr Paula Moran, Dr Kiri Granger, Dr J Mark Treherne , and Dr Jenny Barnett explore the effects of long Covid-19 symptoms and what the opportunities are for drug developers working to treat post-Covid-19 cognitive impairment. New therapeutics of course depend on an understanding of biological mechanisms.

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Development Drugs Clinical Trials Clinical Trials 98

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

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

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

JUNE 24, 2021

Secondary objectives are to describe immune responses produced by each of the vaccines. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer?BioNTech

Vaccination 52

Vaccination Vaccine Immune Response Licensing 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.

Trials 59

Trials Gene Silencing RNA Gene Expression 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 Pharma Companies 59

The Pharma Data

AUGUST 16, 2021

Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of the companies’ COVID-19 vaccine (BNT162b2) for future licensure. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. today announced that they have submitted Phase 1 data to the U.S. In the U.S.,

Vaccination 52

Vaccination Vaccine Immune Response Antibody 52

pharmaphorum

JANUARY 7, 2021

ImaginAb has signed a deal with Pfizer, which it hopes will help it to gather information necessary for approval of its tumour imaging agent as a medical device in markets in the US and other countries. The technology) allows them to make decisions quicker and allows them to triage their drugs more quickly in the clinical phase.”.

Doctors 53

Doctors Doctor Immune Response Pharma Companies 53

Drug Discovery World

MARCH 24, 2023

dendritic cells, monocytes) triggers a broad immune response that includes significant increases in cytotoxic CD8 plus T cells armed with chemo-induced tumour antigens to target cancer. This synergy was demonstrated by the AIPAC Phase IIb trial’s encouraging efficacy and safety, including a over 2.9-month

Trials 52

Trials Immune Response HR Clinical Development 52

pharmaphorum

JUNE 2, 2021

The 50 mcg dose was put through its paces in a study reported last month which found that it was able to generate an encouraging immune response against some key SARS-CoV-2 variants, including the Brazil and South Africa strain – when administered as a booter to previously vaccinated individuals. US marketing application.

Vaccination 52

Vaccination Vaccine Contract Manufacturing Production 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. Source link.

Genetic Engineering 52

Genetic Engineering Genetics Engineer Immune Response 52

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. About TICOVAC (Tick-borne encephalitis vaccine) Pfizer’s TBE vaccine, marketed under the brand names FSME-Immun ® and TicoVac in Europe, and TICOVAC in the U.S.,

FDA Approval 52

FDA Approval Vaccination Vaccine Licensing 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. Download this exclusive report here.

Vaccination 52

Vaccination Vaccine Protein Immune Response 52

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. among adults 65 years of age or older.

Vaccination 52

Vaccination Vaccine Immune Response Containment 52

The Pharma Data

MARCH 29, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

Antibody 52

Antibody In-Vivo Vaccination Vaccine 52

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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Vaccination Vaccine Life Science Clinical Trials 122

The Pharma Data

JUNE 24, 2021

today announced that the Conditional Marketing Authorization (CMA) for COMIRNATY ® in the European Union (EU) has been expanded to include individuals 12 to 15 years of age. or a variation to Conditional Marketing Authorizations (e.g., The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

JULY 23, 2021

BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

Vaccination 52

Vaccination Vaccine Immune Response Production 52

The Pharma Data

JULY 21, 2021

Biovac will obtain drug substance from facilities in Europe, and manufacturing of finished doses will commence in 2022. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Pfizer and BioNTech expect that Biovac’s Cape Town facility will be incorporated into the vaccine supply chain by the end of 2021.

Manufacturing 52

Manufacturing Vaccination Vaccine Clinical Trials 52

The Pharma Data

MAY 6, 2021

BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. Food and Drug Administration (FDA) has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older. Germany, Turkey, South Africa, Brazil and Argentina.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Pharmaceutical Technology

JANUARY 19, 2023

The Korean Ministry of Food and Drug Safety (KMFDS) has granted expanded approval to Novavax partner SK bioscience for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use as a booster dose in adults aged 18 and above. Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain.

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Vaccination Vaccine Immune Response Protein 147

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. Overall, the global CAR-T cell market for all indications was worth $1.7

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Development Immune Response Drugs Marketing 130

XTalks

APRIL 2, 2021

Pfizer and German partner BioNTech are preparing to promptly submit the updated COVID-19 vaccine trial results to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to request expansion of the Emergency Use Authorization (EUA) and EU Conditional Marketing Authorization for BNT162b2. “We

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

The Pharma Data

JANUARY 4, 2021

We believe our allogenic CAR-T platform is significantly stronger with chPD1 target licensed from Longwood University. Chimeric PD-1 T-cells also release cytokines to further initiate immune responses to eradicate the tumor cells. Amorette Barber of Longwood University will be heading up our chPD1 program.

In-Vivo 40

In-Vivo Development Big Data Immune Response 40

Pfizer

FEBRUARY 16, 2023

The companies intend to work with regulatory authorities, and as previously announced, 1,2 aim for Pfizer to potentially submit a Biologics License Application (BLA) to the U.S. VLA15 has demonstrated a strong immune response and satisfactory safety profile in pre-clinical and clinical studies so far.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

Drug Discovery World

SEPTEMBER 6, 2022

There’s no doubt that cell and gene therapies present some of the most exciting opportunities for emerging drugs. Among these include Zolgensma, Novartis’ gene therapy drug for spinal muscular atrophy (SMA), which made headlines in the UK for its £1.79 million price point per dose.

Gene Therapy 52

Gene Therapy Gene Manufacturing Medicine 52

Pfizer

JULY 26, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. Emergency Use Authorization .

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Vaccination Vaccine Protein Immune Response 111

The Pharma Data

DECEMBER 29, 2020

The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized. None of the SAEs were considered to be related to study drug.

Antibody 52

Antibody Trials Production Clinical Trials 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?

Trials 98

Trials Gene Hormones Clinical Trials 98

The Pharma Data

OCTOBER 28, 2020

“The first job of an antiviral therapeutic drug is to lower the viral load, and our initial data in 275 patients strongly suggested that the REGN-COV2 antibody cocktail could lower viral load and thereby potentially improve clinical outcomes. . Regeneron has shared these results with the U.S. combined dose groups; 6.5%

Antibody 40

Antibody Trials Production Clinical Trials 40

The Pharma Data

SEPTEMBER 9, 2020

Food and Drug Administration (FDA), based on preliminary data from Phase 1/2 studies that are currently ongoing in the U.S. During preclinical and clinical studies, BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immune response. About the BNT162 Vaccine Candidate Program.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52