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.

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XTalks

DECEMBER 20, 2021

The EUL from the WHO means that Novavax and its manufacturing partner Serum Institute of India (SII) can begin delivering the vaccine to the COVAX facility program, a global initiative headed by Gavi, the vaccine alliance, as a co-partner, which provides vaccines to low-income countries. Gavi secured 1.1

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pharmaphorum

MAY 11, 2021

The technology is designed to replace antibodies, which have become standard therapy in many diseases but are complicated and expensive to manufacture. Unlike the strips of mRNA used to create Moderna’s COVID-19 vaccine, eRNA runs in a circle and has been specially modified to allow the body to read the code it contains.

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The Pharma Data

DECEMBER 11, 2020

Thermo Fisher joined forces with the University of Oxford to harness its academic research capabilities in quantifying IgG antibodies and understanding each patient’s immune response to SARS-CoV-2. Sensitech technology helps to ensure the container refrigeration units can deliver a temperature control within +/- 0.25-degrees

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pharmaphorum

AUGUST 23, 2021

Ahmedabad-based Zydus Cadila has said it expects to launch ZyCoV-D in late September or early October, and expects to be able to manufacture around 100-120 million doses a year, with around 10 million available at launch. Proponents of the approach claim that DNA vaccines may have advantages over other technologies like mRNA.

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Camargo

DECEMBER 13, 2021

An application submitted under 351(a), also known as a “stand-alone” application, must contain all safety and effectiveness information for a biological product and cannot depend on any other biological product. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.

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The Pharma Data

DECEMBER 16, 2020

Currently in Phase 3 clinical testing in the United Kingdom for the prevention of COVID-19, NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax’ proprietary Matrix-M to enhance the immune response. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. About Novavax.

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XTalks

APRIL 26, 2021

Moreover, a very strong immune response is needed to fend off the disease. With the commitment by our commercial partner, the Serum Institute of India, to manufacture at least 200 million doses annually in the coming years, the vaccine has the potential to have major public health impact if licensure is achieved.”.

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Pharmaceutical Technology

NOVEMBER 22, 2022

According to CEPI: “Achieving the 100 Days Mission would give the world a fighting chance of containing a future outbreak before it spreads to become a global pandemic.”. Messenger RNA vaccines contain nucleic acids that code for a specific protein, or target antigen, related to a virus or disease.

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Worldwide Clinical Trials

JUNE 15, 2022

Consulting with regulatory experts and experts in toxicology, manufacturing, etc., There have been a few cases lately where patients receiving gene therapy had a severe adverse effect because of their immune response to the mechanism of the AAV viral vector, based on their own genomic markers.

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The Pharma Data

OCTOBER 25, 2020

In parallel we are scaling up our manufacturing capability with our strategic partners, Lonza and Rovi, to address this global health emergency by delivering a safe and effective vaccine to the people of Qatar and around the world.”. On Thursday, October 22, Moderna completed enrollment of the Phase 3 COVE study. About Moderna.

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Roots Analysis

FEBRUARY 18, 2022

Myeloid cells represent a group of cells containing granulocytes, monocytes, macrophages, mast cells and dendritic cells, which play a key role in innate immunity. Over time, many research studies have shown that myeloid cells can interact with the immune system and aid in generating an appropriate anti-tumor immune response.

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XTalks

NOVEMBER 23, 2020

Oxford-AstraZeneca COVID-19 Vaccine Induces Immune Responses in Early Clinical Trials. As a manufacturing partner for Oxford’s vaccine, AstraZeneca is ramping up its production capabilities as it plans to make up to three billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval.

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Pfizer

FEBRUARY 16, 2023

VLA15 has demonstrated a strong immune response and satisfactory safety profile in pre-clinical and clinical studies so far. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

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

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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). About AstraZeneca.

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The Pharma Data

NOVEMBER 30, 2020

We continue to make meaningful progress as we work to test, manufacture and ultimately deliver NVX-CoV2373 with unprecedented speed, as well as put partnerships in place that would ensure widespread and equitable access worldwide.”. and Mexico pivotal Phase 3 trial and manufacturing scale-up. . Mexico pivotal Phase 3 trial update.

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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. About Pneumococcal Disease.

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The Pharma Data

MARCH 8, 2021

, preliminary evidence suggests that canakinumab inhibits pro-tumor inflammation (PTI) to 1) enhance anti-tumor immune response; 2) reduce tumor cell proliferation, survival and invasiveness; and 3) impair angiogenesis 8. Canakinumab is a first-in-class interleukin-1beta (IL-1?) Disclaimer. Source link:[link].

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The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The study showed this broad immune response led to the complete clearance of the virus in a matter of days after infection of previously-vaccinated primates. and its affiliate NantKwest, Inc.

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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.

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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.

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The Pharma Data

DECEMBER 11, 2020

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. Manufacturing and Delivery Capabilities. Germany, Turkey, South Africa, Brazil and Argentina. Pfizer is leveraging three of its U.S.

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The Pharma Data

APRIL 22, 2023

“This means that vaccine manufacturers will have to keep creating new vaccines that target new variants, and people have to keep getting these new vaccines,” he said. These epitopes elicit an immune response from a broad selection of T cells, ensuring a sustained coverage of future variants.

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The Pharma Data

JANUARY 31, 2021

Clover’s S-Trimer antigen adjuvanted with CpG 1018 plus alum demonstrated low reactogenicity while providing high levels of neutralizing antibodies and a strong Th1-biased cell-mediated immune response. Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B.

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The Pharma Data

JANUARY 11, 2021

Xiaomin Fan, Founder, President and CEO of AvantGen, “Even with the recent Emergency Use Authorization of multiple vaccines, we believe there remains an urgent need for potent antibody therapies and prophylactics for immunocompromised patients who cannot mount an adequate immune response either to the vaccine or to subsequent viral infection.

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The Pharma Data

NOVEMBER 18, 2020

is a commercial stage, FDA cleared, bioelectronic medical device manufacturing company initially focused on the treatment of various chronic, acute, intractable, and post-operative pain conditions. . SCOTTSDALE, Ariz., 19, 2020 (GLOBE NEWSWIRE) — Electromedical Technologies, Inc. million of inventory to meet demand.

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The Pharma Data

DECEMBER 18, 2020

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts. The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. SILVER SPRING, Md. , 18, 2020 /PRNewswire/ — Today, the U.S.

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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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The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.

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The Pharma Data

SEPTEMBER 8, 2020

Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies.

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XTalks

AUGUST 17, 2020

Treatment vaccines : these boost the immune system responses to target cells. Immune system modulators (i.e. receptors) of the immune system to enhance, or suppress immune responses. protein-based biologics) : are those which bind to specific components (i.e. Nature by Design. Image from Cue Biopharma.

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The Pharma Data

SEPTEMBER 8, 2020

Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech. This press release contains “forward-looking statements” of. Every day, Pfizer.

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The Pharma Data

JANUARY 24, 2021

In these studies, both V590 and V591 were generally well tolerated, but the immune responses were inferior to those seen following natural infection and those reported for other SARS-CoV-2/COVID-19 vaccines. government to advance the manufacturing and initial distribution of MK-7110 ( link ).

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pharmaphorum

SEPTEMBER 2, 2021

In contrast, small molecule alternatives can be manufactured at a relatively low cost and administered orally but suffer from potential biological ‘promiscuity’. CIRs give these natural antibodies this recognition ability and therefore circumvent the need to immunise an individual to generate SARS-CoV-2 specific antibodies.

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The Pharma Data

DECEMBER 10, 2020

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. The information contained in this release is as of December 10, 2020. Germany, Turkey, South Africa, Brazil and Argentina.

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The Pharma Data

MAY 6, 2021

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The information contained in this release is as of May 6, 2021. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

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