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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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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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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pharmaphorum

MAY 31, 2022

billion takeover of US biotech Affinivax, buying a pneumococcal vaccine candidate that is aiming to break into a market that for years has been dominated by Pfizer’s Prevnar franchise. The biotech says this can stimulate both B cell (antibody) and T cell immune responses with a single shot. GlaxoSmithKline has agreed a $3.3

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The Pharma Data

SEPTEMBER 30, 2021

The function of the adjuvant is to market the body’s immune reaction. Our results show that the candidate vaccine formulation is safe, produces rapid immune responses – within seven days – and elicits comprehensive immunity against SARS-CoV-2,” said Varadarajan.

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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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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

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

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

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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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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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

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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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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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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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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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

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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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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XTalks

MAY 30, 2024

CIDP is a rare autoimmune disorder where the body’s immune system mistakenly attacks its own tissues. The exact cause of this immune response is unknown, and there appears to be no identifiable genetic predisposition to CIDP. Researchers estimate that the incidence of CIDP in the US ranges from 0.8

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Pharmaceutical Technology

OCTOBER 28, 2022

On 24 October, American vaccine developer Vaxcyte shared positive topline data from a Phase I/II study of its multivalent conjugate pneumococcal vaccine VAX-24 , bringing the 24-valent pneumococcal jab one step closer to market. What’s more, VAX-24 achieved a higher immune response to 16 of the 20 serotypes it shares with Prevnar 20.

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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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The Pharma Data

FEBRUARY 24, 2022

The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on a variation to the Conditional Marketing Authorization in the near future. No new safety concerns were identified from the data available.

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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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The Pharma Data

SEPTEMBER 7, 2021

Bristol Myers Squibb has a global exclusive license to develop, manufacture and commercialize the Rockefeller University’s novel monoclonal antibody (“mAb”) duo treatment that neutralizes the SARS-CoV-2 virus for therapy or prevention of COVID-19. We are committed to implementing similar requirements in other markets wherever possible.

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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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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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Pfizer

NOVEMBER 2, 2022

The influenza virus is subject to constant mutations to evade the host immune response, causing a seasonal variation in circulating strains. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

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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

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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.

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The Pharma Data

SEPTEMBER 9, 2020

producing CD8+ T cell responses, which is thought to promote an anti-viral effect. In a preclinical murine model, a single IM immunization of BNT162b2 (0.2, CD4+ and CD8+ T-cells from splenocytes isolated from BNT162b2-immunized mice were strongly positive for IFN?

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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.

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