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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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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The Pharma Data

SEPTEMBER 30, 2021

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. A fundamental limitation of intramuscular vaccines is that they’re not designed to elicit mucosal immunity.

Vaccination 52

Vaccination Vaccine Immune Response Licensing 52

pharmaphorum

JULY 18, 2022

It then elicits an immune response against that spike protein. You have a response with immunoglobulins type G (antibodies) and robust cellular response with both CD4 and CD8 T-cells being activated,” Morgon states. We get a higher immune response with the inhaled compared to the injectable,” Morgon relays.

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Vaccination Vaccine Development Immune Response 135

The Pharma Data

OCTOBER 26, 2020

based company said the preventative medication boosts immune responses in older and younger adults against the novel coronavirus. Roche and Atea Pharmaceuticals are partnering to develop, manufacture and distribute AT-527, Atea’s experimental antiviral drug against COVID-19. Please read more here. .

Antibody 52

Antibody Vaccination Vaccine Manufacturing 52

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. Before the BioKangtai tie-up, it promised to provide the U.S.

Vaccination 52

Vaccination Vaccine Antibody Licensing 52

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.

Immune Response 53

Immune Response Doctor Doctors Pharma Companies 53

The Pharma Data

AUGUST 28, 2020

Oxford coronavirus vaccine triggers immune response. The UK remains under the jurisdiction of the European Medicines Agency and its licensing scheme until the end of the Brexit transition period on 31 December 2020. UK signs deals for 90 million virus vaccine doses.

Vaccination 52

Vaccination Vaccine Immune Response Medicine 52

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. Department of Defense have contributed significant funding to the advancement and manufacturing of INO-4800. ClinicalTrials.gov identifier: NCT04336410.

DNA 40

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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.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

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.

Vaccination 72

Vaccination Vaccine Immune Response Antibody 72

The Pharma Data

JANUARY 17, 2021

By inhibiting calcineurin, the drug blocks IL-2 expression and T-cell mediated immune responses. On December 17, 2020, Aurinia inked a collaboration and license deal with Japan’s Otsuka Pharmaceutical Co. On December 17, 2020, Aurinia inked a collaboration and license deal with Japan’s Otsuka Pharmaceutical Co.

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Manufacturing Immune Response Allergies Drugs 52

The Pharma Data

JUNE 26, 2021

“We believe that mRNA technology could have several advantages for a seasonal flu application including the potential ability to demonstrate robust immune responses based on preclinical data to date, enable antigen specificity within a short timeframe from seasonal virus strain selection, and deploy agile manufacturing capacity.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

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). About AstraZeneca.

Vaccination 52

Vaccination Vaccine Immune Response Medicine 52

XTalks

JUNE 21, 2024

This transition led to roles in companies such as Shire, which spun out a division to start a new company called Supernus Pharmaceuticals, in which he engaged in corporate development, licensing and strategic management, taking companies public and navigating mergers and acquisitions.

Development 52

Development Immune Response Drugs Regulation 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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Vaccination Vaccine Development Clinical Trials 82

The Pharma Data

AUGUST 15, 2021

anaphylaxis) to any component of TICOVAC Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of TICOVAC Some individuals with altered immunocompetence may have reduced immune responses to TICOVAC TICOVAC contains albumin, a derivative of human blood.

FDA Approval 52

FDA Approval Vaccination Vaccine Licensing 52

pharmaphorum

JANUARY 8, 2021

This means that the vaccine is not being delivered as licensed. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine.”. “The On the basis of UK government guidance yesterday.

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pharmaphorum

JANUARY 8, 2021

This means that the vaccine is not being delivered as licensed. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine.”. “The On the basis of UK government guidance yesterday.

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Vaccination Vaccine Immune Response Trials 53

The Pharma Data

FEBRUARY 24, 2022

The Committee considered that the available evidence was sufficient to conclude that the immune response to a booster dose in adolescents would be at least equal to that in adults. No new safety concerns were identified from the data available.

Vaccination 52

Vaccination Vaccine Production Immune Response 52

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.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

SEPTEMBER 9, 2020

The vaccine supply for the EU would be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium. Vaccine doses for Europe would be produced in BioNTech’s German manufacturing sites, as well as in Pfizer’s manufacturing site in Belgium. billion doses by the end of 2021.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Pfizer

NOVEMBER 2, 2022

The flexibility and manufacturing speed of the mRNA technology has demonstrated that it is well-suited for other respiratory diseases. The influenza virus is subject to constant mutations to evade the host immune response, causing a seasonal variation in circulating strains. EMERGENCY USE AUTHORIZATION.

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Vaccination Vaccine Clinical Trials Clinical Trials 85

pharmaphorum

AUGUST 27, 2020

To use the analogy of vaccine discovery being akin to striking gold during the Klondike Rush of the late nineteenth century, there are a raft of companies profiting from selling ‘picks and shovels’ – whether this is developing associated treatments and diagnostics, or manufacturing devices.

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Vaccination Vaccine Life Science Clinical Trials 115

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?

Vaccination 52

Vaccination Vaccine RNA Clinical Trials 52

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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Clinical Trials Clinical Trials Vaccination Vaccine 76

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. Contributions to Research, Life-Sciences Industry. and Puerto Rico.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Medicine 52

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., The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational.

Antibody 52

Antibody Trials Production Clinical Trials 52

The Pharma Data

NOVEMBER 20, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

Antibody 52

Antibody Production Clinical Trials Clinical Trials 52

The Pharma Data

MAY 7, 2021

The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

Licensing 52

Licensing Licensing Vaccination Vaccine 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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The Pharma Data

AUGUST 20, 2020

T cell immune responses elicited by BNT162b2 are being evaluated in the German study and the companies expect to submit the data for peer review and potential publication. trial and we look forward to sharing T cell immune response data from the German trial in the near future.”. “It View the full release here: [link].

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Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Trials 52

The Pharma Data

OCTOBER 28, 2020

“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. and Roche will develop, manufacture and distribute it outside the U.S. Yancopoulos , M.D., combined dose groups; 6.5%

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The Pharma Data

DECEMBER 20, 2020

This oncolytic virus has induced long-lasting antitumor immune responses and abscopal effects in several tumor models, and its activity is further enhanced through combination with an anti-PD-1 antibody treatment. The Company’s validated, proprietary F.I.R.S.T More information is available at www.bioinvent.com.

Trials 52

Trials Antibody Clinical Trials Clinical Trials 52

The Pharma Data

OCTOBER 14, 2020

(Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the observational PRECISION study (TNX-C002), to examine the immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic. 1 Noyce RS, et al.

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The Pharma Data

NOVEMBER 21, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

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