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.

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Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

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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.

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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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pharmaphorum

NOVEMBER 24, 2020

Sputnik V’s developers say its high level of efficacy comes from the use of two different adenoviral vectors which “allows for a stronger and longer-term immune response as compared to the vaccines using one and the same vector for two doses.”. The next analysis for Sputnik V will be made when there are 78 confirmed coronavirus cases.

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XTalks

MAY 2, 2024

Some treatments already on the market have grabbed additional approvals in 2024, including Novo Nordisk’s Wegovy (semaglutide) for cardiovascular risk reduction, Dupixent (dupilumab) for eosinophilic esophagitis (EoE) in young children and Xolair (omalizumab) for food allergies. It is also entering late into the market. billion ($1.5

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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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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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XTalks

MAY 1, 2023

Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. Reduction in these two biomarkers in response to tofersen is believed to predict clinical benefit for patients. The recommended dosage of Qalsody is 100 mg (15 mL) per administration.

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The Pharma Data

AUGUST 6, 2020

We pointed out last week that China was a notable missing element in AstraZeneca’s COVID-19 vaccine strategy, despite being the drugmaker’s second-largest market. The pair will also explore the possibility of producing the vaccine for other markets. The country is its second-largest market, behind the U.S., That has changed.

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pharmaphorum

JUNE 22, 2022

Merck also sells an older shot called Pneumovax 23, which covers 23 serotypes but is based on an older polysaccharide technology that does not stimulate the immune response as strongly as the newer conjugate vaccines. Those eight strains account for more than 30% of the disease burden caused by S pneumoniae , said the drugmaker.

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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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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

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The Pharma Data

AUGUST 16, 2021

Pfizer and BioNTech plan to seek licensure of the third dose via a supplemental Biologics License Application (BLA) in individuals 16 years of age and older, pending FDA approval of the primary BLA submitted in May 2021. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. In the U.S.,

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pharmaphorum

DECEMBER 1, 2021

The biotech is also following a second line of development for plinabulin as a cancer treatment, based on research showing the drug can boost cell-based immune responses to tumours. The post BeyondSpring faces a tough winter as FDA rejects its lead drug appeared first on.

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The Pharma Data

MAY 27, 2022

The authorisation is based on a review by the Committee for Medicinal Products for Human Use (CHMP) of the substantial body of evidence demonstrating an increased immune response after a third dose booster with Vaxzevria following a primary vaccine schedule of either Vaxzevria or an mRNA COVID-19 vaccine.(1-5).

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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.

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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.

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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

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pharmaphorum

FEBRUARY 9, 2021

MicroRNAs are smaller than the small interfering RNA (siRNA) drugs now reaching the market, such as Alnylam’s Onpattro (patisiran), Givlaari (givosiran) and Oxlumo (lumasiran) for rare diseases. Regulus meanwhile remains a microRNA player, but has suffered a number of setbacks.

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The Pharma Data

AUGUST 15, 2021

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., More than 45 years of experience with the Pfizer TBE vaccine exist outside the U.S., and more than 170 million doses of the vaccine have been distributed since 1976.

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pharmaphorum

DECEMBER 21, 2020

In preclinical testing, its TRACTr drugs have been shown to offer the same anti-tumour activity as older T-cell engager drugs, but don’t cause the release of cytokines that can lead to a runaway immune response and damage to healthy tissues. The post Merck cuts $1bn deal with Janux for cancer T-cell therapies appeared first on.

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The Pharma Data

JANUARY 17, 2021

One consideration in using syngeneic models is that some drug candidates can cause a negative immune response not seen in humans. Taconic Biosciences is a fully-licensed, global leader in genetically engineered rodent models and services. About Taconic Biosciences, Inc. Source link.

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The Pharma Data

DECEMBER 23, 2020

All 38 subjects who were evaluable for immunogenicity had balanced cellular and humoral immune responses following the second dose of INO-4800. The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune responses. .

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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.

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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.

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The Pharma Data

MARCH 25, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for 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.

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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.

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Pfizer

JULY 8, 2022

Following a third dose in this age group , the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. Some people with weakened immune systems may have reduced immune responses to Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA).

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Pfizer

JULY 19, 2022

The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 1 as compared to the companies’ current COVID-19 vaccine. Emergency Use Authorization.

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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.

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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.

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The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

Pfizer

JULY 8, 2022

Food and Drug Administration (FDA) approved the companies’ supplemental Biologics License Application (sBLA) for their COVID-19 vaccine, known as COMIRNATY® (COVID-19 Vaccine, mRNA), to include individuals 12 through 15 years of age. NEW YORK and MAINZ, GERMANY, July 8, 2022 — Pfizer Inc. have completed a primary series.

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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.

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The Pharma Data

JULY 21, 2021

Government at a not-for-profit price, that the government will, in turn, donate to the African Union and the COVAX 92 Advanced Market Commitment (AMC) countries, as well as a direct supply agreement with the COVAX facility for 40 million doses. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

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pharmaphorum

AUGUST 27, 2020

In the UK, structural problems of the AIM market have compounded these problems by driving institutional investors away from relatively illiquid shares. Conventional vaccines introduce an inactivated sample of a disease to patients with the aim of stimulating an immune response. COVID-19 sparks change.

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