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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pharmaphorum

DECEMBER 2, 2021

Along with improved targeting and safety, the capsids are designed to be able to contain larger genes and be easier to manufacture. Astellas effectively created its gene therapy division when it acquired Audentes Therapeutics – which developed AT132 – for $3 billion in 2020.

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The Pharma Data

OCTOBER 25, 2020

We are advancing the clinical development of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. For more information about the COVE study, click here. mRNA-1273 currently is not approved for use by any regulatory body.

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The Pharma Data

OCTOBER 28, 2020

Over the past nine years, Moderna has invested in creating and developing a novel platform for designing and manufacturing a new class of mRNA-based vaccines. A summary of the company’s work to date on COVID-19 can be found here. mRNA-1273 currently is not approved for use by any regulatory body. Forward-Looking Statements.

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pharmaphorum

SEPTEMBER 8, 2022

This is an important capability because radiopharmaceuticals require just-in-time manufacture and delivery each week. With investment and approvals beginning to flow into the area, there are a growing number of start-ups and established companies that are looking to develop radiopharmaceuticals. Few organizations today can do that.”.

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The Pharma Data

DECEMBER 10, 2020

executive vice president of research and development. “We We look forward to working closely with the FDA throughout the clinical development process to bring this potential new innovative treatment to patients as quickly as possible.”. Safe Harbor Statement.

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The Pharma Data

DECEMBER 23, 2020

24, 2020 /PRNewswire/ — COVAXX’s UB-612 is the first multitope, synthetic peptide-based COVID-19 vaccine candidate in clinical trials and it utilizes normal refrigeration (no freezing required) for distribution. COVAXX is currently conducting a Phase 1 clinical trial for the vaccine candidate. .

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XTalks

NOVEMBER 9, 2023

XTALKS WEBINAR: The Evolution of the Cardiovascular Clinical Development Landscape and Potential Role of GLP-1 RAs Live and On-Demand: Wednesday, December 6, 2023, at 11am EST (4pm GMT/UK) Register for this free webinar to learn about successful study outcomes in developing GLP1s to new therapeutic areas within cardiovascular medicine and more.

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Pfizer

AUGUST 3, 2022

We innovate every day leveraging our global footprint to accelerate the development and delivery of groundbreaking medicines and the hope of cures. Learn more about our Rare Disease portfolio and how we empower patients, engage communities in our clinical development programs, and support programs that heighten disease awareness.

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The Pharma Data

DECEMBER 23, 2020

During this global health crisis response, we must establish partners with the strongest capabilities, like Aurobindo, to expand the manufacturing and delivery of our vaccine. Aurobindo Pharma and COVAXX are partnering on clinical development, manufacturing and marketing of COVAXX’s vaccine candidate, UB-612.

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pharmaphorum

SEPTEMBER 14, 2020

The UK government already has an order for 30 million doses with AstraZeneca, which the company has already begun to manufacture at risk ahead of approval. The vaccine is top of the list of 35 potential coronavirus vaccines in clinical development, according to a list maintained by the World Health Organization.

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Worldwide Clinical Trials

JUNE 15, 2022

Consulting with regulatory experts and experts in toxicology, manufacturing, etc., Early engagement and discussions can help you prevent the risk of a clinical hold. To discuss your study and how to reduce the chances of receiving a clinical hold, talk with us. . The cell and gene therapy pipeline is booming.

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XTalks

APRIL 24, 2023

For rare disease studies where there is little or no clinical trial experience, outcome assessments would have to be validated within a clinical development program. Early and ongoing engagement with regulators greatly helps clinical development planning.

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pharmaphorum

OCTOBER 30, 2019

Pathways have not held up to their promise for containing cost. For example, PD-1/PDL-1 drugs have shown conflicting outcomes associated with receptor expression – and these drugs are the backbone for many combo regimen programs in clinical development. However, there are limitations in the breadth and utility of these tools.

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Pfizer

FEBRUARY 16, 2023

While VLA15 is still under investigation, to date the companies have been encouraged by the data from the Phase 2 clinical studies, which demonstrated strong immunogenicity and acceptable safety and tolerability profiles. 2-4 About VLA15 VLA15 is the only Lyme disease vaccine candidate currently in clinical development.

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The Pharma Data

JANUARY 3, 2021

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Except as required by law, TLC expressly disclaims any responsibility to update any forward-looking statement contained herein, whether as a result of new information, future events or otherwise.

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The Pharma Data

JANUARY 27, 2021

We are pleased to be advancing our second therapy into clinical development in our quest to bring transformative medicines to patients who need them,” said Bruce Goldsmith, Ph.D., We are excited to investigate the potential of PBFT02 as a treatment for FTD-GRN as we initiate our clinical development program in the coming months.”.

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Pfizer

SEPTEMBER 28, 2022

1-adapted bivalent vaccine, non clinical and manufacturing data from the companies’ 10-µg Omicron BA.4/BA.5-adapted Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus . 5-adapted bivalent vaccine. Pfizer Disclosure Notice.

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Pfizer

NOVEMBER 2, 2022

The vaccine candidate combines Pfizer’s quadrivalent modRNA-based influenza vaccine candidate, qIRV (22/23), which is currently in Phase 3 clinical development , and Pfizer and BioNTech’s authorized Omicron-adapted bivalent COVID-19 BNT162b2 (Original/Omicron BA.4/BA.5) COMIRNATY® (COVID-19 Vaccine, mRNA). INDICATION.

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Pharmaceutical Technology

NOVEMBER 25, 2022

PDF scale and reformulation challenge manufacturers. But the challenges for drug producers developing PDFs are numerous and varied. First and foremost, CDMOs must have expertise in formulation sciences and proven formulation success in clinical development and commercial approvals.

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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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Delveinsight

JULY 27, 2021

This globalized COVID-19 vaccine supply chain and manufacturing network, incorporates 3 continents and will contain around 20 manufacturing facilities. As suggested by analysts, the most rapid, cost-effective and easiest way of vaccine development is regional partnership with prominent vaccines developers.

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XTalks

AUGUST 2, 2023

is a global pharmaceutical company, working across both developed and emerging markets. Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. It contains the antiviral medications nirmatrelvir and ritonavir. every eight weeks for the 90 mg dose, according to the manufacturer.

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XTalks

OCTOBER 26, 2023

She has 23 years of experience working with clients to move vaccine candidates through the clinical development pipeline, including regulatory submission. The Flu versus COVID-19: Virology and Vaccines SARS-CoV-2 versus Influenza Virology Viruses contain genetic material that can either be RNA or DNA.

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The Pharma Data

NOVEMBER 3, 2020

According to the FDA, the purpose of Fast Track designation is to get important new drugs to patients earlier by facilitating the development, and expediting the review, of drugs to treat serious conditions and fill an unmet medical need. Commenting on the announcement, Daniel Gruskin, M.D., LogicBio is headquartered in Lexington, Mass.

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The Pharma Data

OCTOBER 25, 2020

SQI is accelerating the clinical development of its direct-to-consumer COVID-19 HOME Antibody Test, its COVID-19 RALI-dx Severity Triage Test and its COVID-19 RALI- fast Severity Triage Point-of-Care (POC) Test. About SQI Diagnostics. SQI Diagnostics, Inc. FORWARD-LOOKING INFORMATION.

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The Pharma Data

JANUARY 10, 2021

Editas Medicine is preparing to initiate the RUBY clinical trial, a Phase 1/2 trial designed to assess the safety and efficacy of EDIT-301 for the treatment of sickle cell disease. The Company has identified a lead principal investigator and engaged a Clinical Research Organization (CRO).

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The Pharma Data

DECEMBER 23, 2020

The Company has Now Resumed the Clinical Development of its Proposed Anti-Nausea Pharmaceutical Grade Version of Tauri-Gum. With this funding now complete, the Company is excited about its prospects for 2021 – as it pertains to its pharmaceutical development efforts. . NEW YORK, NY, Dec. Provisional Patent Application No.

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The Pharma Data

NOVEMBER 20, 2020

Both collaborators are committed to developing this novel vaccine with preclinical and clinical data at the forefront of all their decision making. Manufacturing and Delivery Capabilities. and Europe, and complementing the mRNA manufacturing expertise of BioNTech, gained over almost a decade. Pfizer Disclosure Notice.

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The Pharma Data

JANUARY 21, 2021

Spectrum Pharmaceuticals is a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted oncology therapies. The company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.

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The Pharma Data

JANUARY 27, 2021

The two-hour event will cover various topics, including an overview of the Company’s board and executive leadership, its commitment to environment, social and governance (ESG) matters, and progress updates on the Company’s critical care programs, manufacturing and distribution approach, and commercial readiness plans. About MultiStem ®.

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Pfizer

DECEMBER 8, 2022

The vaccine candidate is based on BioNTech’s proprietary mRNA platform technology and contains mRNA strands encoding the wild-type spike protein of SARS-CoV-2 and the spike protein of the Omicron sublineages BA.4/BA.5, The information contained in this release is as of December 9, 2022. COMIRNATY® (COVID-19 Vaccine, mRNA). INDICATION.

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XTalks

NOVEMBER 6, 2020

We are exceptionally pleased to commence dosing of our oral DNA vaccine for COVID-19 as we continue scale-up and manufacturing activities for future clinical development,” Symvivo’s chief medical officer Eric Sievers said in a press release from the company. COVID-19 Clinical Trials.

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Pfizer

JULY 26, 2022

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. The information contained in this release is as of July 27, 2022. Pfizer Disclosure Notice.

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The Pharma Data

DECEMBER 1, 2020

Today’s decision also is based on a review of Pfizer’s and BioNTech’s Chemistry, Manufacturing and Control (CMC) data for BNT162b2. Manufacturing and Delivery Capabilities. Pfizer has a 171-year track record of researching, developing, manufacturing and delivering innovative medicines and vaccines to patients in need.

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The Pharma Data

SEPTEMBER 8, 2020

Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to: Always make the safety and well-being of vaccinated individuals our top priority. Sanofi, Empowering Life.

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The Pharma Data

APRIL 27, 2021

COMIRNATY® will be produced in BioNTech’s and Pfizer’s manufacturing sites in Europe. 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. The information contained in this release is as of April 19, 2021.

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