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

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

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

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis). The results passed the futility analysis (p<0.3

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Drug Discovery World

FEBRUARY 28, 2024

Using IgE to treat cancer In the UK, a Cancer Research UK-funded clinical trial has shown, for the first time, that a new class of antibody could benefit cancer patients whose existing treatments have stopped working. The drug, MOv18 IgE (an anti-folate receptor alpha IgE antibody), was developed by researchers at King’s College London.

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XTalks

APRIL 26, 2021

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. Two different doses of the adjuvant (MM) were assessed (25 mcg and 50 mcg).

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pharmaphorum

MAY 18, 2021

.” The interim phase 2 results show that two doses of the plant-derived jab stimulated neutralising antibody levels that are around 10 times higher than those in a panel of sera from patients recovering from COVID-19, with a similar response seen in adults and the elderly.

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pharmaphorum

AUGUST 24, 2020

Forbius has also been working on some other targets, including an EGFR-targeting antibody-drug conjugate (ADC), but these will be spun into another company that will remain in the hands of its current shareholders.

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The Pharma Data

NOVEMBER 10, 2021

Next generation vaccines for COVID-19 should aim to induce an immune response against ‘replication proteins’, essential for the very earliest stages of the viral cycle, concludes new research carried out by UCL scientists. ” Why might some individuals be able to clear an infection better than others?

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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The Pharma Data

MAY 7, 2021

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 COVID-19 Vaccine. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

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The Pharma Data

OCTOBER 28, 2020

NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron.

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The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio. Expected to enroll 415 participants; interim results expected in Q3 2021.

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Clinical Trials Clinical Trials Vaccination Vaccine 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.

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The Pharma Data

NOVEMBER 17, 2020

Lead Pharma has entered into a collaboration and license agreement with Roche , hoping to lead the way in the development of oral small molecules for immune-mediated diseases like rheumatoid arthritis, psoriasis and inflammatory bowel diseases. .

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The Pharma Data

AUGUST 16, 2021

The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule. 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.,

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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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XTalks

MAY 1, 2023

Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. Tegoprubart is an anti-CD40L antibody designed to inhibit the CD40 and CD11 costimulatory signaling pathways. The recommended dosage of Qalsody is 100 mg (15 mL) per administration.

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The Pharma Data

AUGUST 6, 2020

AstraZeneca reached a licensing deal with Chinese firm BioKangtai to help provide its adenovirus vector-based COVID-19 vaccine candidate, created by the University of Oxford, to China, AstraZeneca said (Chinese) in a social media post on Thursday. That has changed. The vaccine was moved into phase 2/3 in May. RELATED: AstraZeneca scores $1.2B

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pharmaphorum

SEPTEMBER 8, 2022

g) dose of Novavax’ Matrix-M adjuvant, used to boost the immune response to the R21 antigen. The vaccine is licensed to the Serum Institute of India – which also produced the AZ COVID-19 vaccine – and the company has said it will be able to manufacture at least 200 million doses annually from next year if authorised.

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The Pharma Data

OCTOBER 26, 2020

Diagnostics Update : To-date the FDA has authorized 284 individual EUAs, which include 221 molecular tests, 56 antibody tests and 7 antigen tests. . Only a fraction of intravenous antibody treatments will make their way to the lungs of COVID-19 patients, which is where the infection is primarily located. Please read more here. .

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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. . Keitma/Shutterstock. It is being developed for the treatment of solid tumors.

Immune Response 52

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pharmaphorum

DECEMBER 15, 2020

Phase 1 data from 300 healthy females have so far shown a favourable safety profile, while generating high levels of long-lasting antibodies. These are capable of mobilising the immune system against GBS bacteria and preventing invasion of epithelial and endothelial cell barriers. The post Minervax raises €47.4m

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Delveinsight

JANUARY 21, 2021

Eli Lilly, via its Loxo Oncology biotech unit, is enlisting to a three-therapy pact with Merus concentrated on T-cell redirecting bispecific antibody work. These will come out of Merus’ so-called Biclonics platform that develops CD3-engaging, T-cell redirecting bispecific antibody therapies. billion in total for three drugs.

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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.

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Doctors Doctor Immune Response Pharma Companies 51

pharmaphorum

DECEMBER 21, 2020

billion acquisition of VelosBio and its anti-ROR1 antibody-drug conjugate (ADC) VLS-101, as well as a partnership with Dragonfly Therapeutics for a cancer programme based on the biotech’s TriNKET natural killer (NK) cell engager platform. billion alliance with Taiho and Astex for cancer antibodies, including a KRAS drug, and a $4.2

Immune Response 52

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XTalks

MAY 2, 2024

The Prescription Drug User Fee Act (PDUFA) date is the deadline that the FDA sets for reviewing a New Drug Application (NDA) or Biologics License Application (BLA) and making a final decision on marketing approval. Alexion, AstraZeneca Rare Disease is serving as a licensing partner of BridgeBio’s affiliate, Eidos Therapeutics, Inc.,

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pharmaphorum

FEBRUARY 9, 2021

It interacts with signalling pathways involved in the proliferation of cancer cells and impairs their ability to spread, whilst driving them into programmed cell death (apoptosis) and encouraging a T cell-mediated immune response.

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The Pharma Data

DECEMBER 23, 2020

Stanley Plotkin , Professor Emeritus at The Wistar Institute, said, “INOVIO’s DNA vaccine appeared to be quite safe with few significant reactions but yet induced both antibody and T cell responses to SARS-CoV-2.” mg dose group and 84% demonstrating neutralizing antibodies in the 2.0 mg and 2.0 The 1.0

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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. Standard mice may develop anti-drug antibodies (ADA), which can neutralize the therapeutic or even trigger anaphylaxis. About Taconic Biosciences, Inc.

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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., 7 It is able to induce neutralizing antibodies against the natural TBE virus, as the sequence and structure of the virus subtype match those found in nature.

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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.

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pharmaphorum

JANUARY 12, 2021

ImmunityBio has licensed technology underpinning a COVID-19 vaccine that could be administered orally rather than by injection from UK biotech iosBio. Soon-Shiong said that oral vaccines could have another key advantage as they stimulate mucosal, systemic and T-cell immune responses. “As

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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

JULY 11, 2021

Phase 3 study met primary and secondary endpoints demonstrating MenQuadfi ® induced superior immune responses to serogroup C compared to a standard-of-care vaccine in healthy toddlers MenQuadfi is the first and only quadrivalent ACWY vaccine to demonstrate superior immune response against serogroup C in toddlers.

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Immune Response Vaccination Vaccine Licensing 52

pharmaphorum

SEPTEMBER 2, 2020

The drug, JTX-1811, is a monoclonal antibody designed to selectively deplete immunosuppressive tumour-infiltrating T regulatory (TITR) cells. . When JTX-1811 binds to CCR8, it targets TITR cells for depletion by an enhanced antibody-dependent cellular cytotoxicity mechanism. . In 2016 Celgene signed a $2.6

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XTalks

APRIL 2, 2021

In a pivotal Phase III trial involving adolescents 12 to 15 years of age, Pfizer/BioNTech’s COVID-19 vaccine trial results show that its vaccine, BNT162b2, has a demonstrated efficacy of 100 percent and elicits strong antibody responses. 1.351 variant, which may have the potential to evade the immune response.

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