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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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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pharmaphorum

JANUARY 25, 2021

The company – known as MSD outside North America – said that although the vaccines were well tolerated, the immune responses seen were weaker than natural immunity and those reported for other SARS-CoV-2 vaccines. government to advance the manufacturing and initial distribution of MK-7110.

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pharmaphorum

DECEMBER 15, 2020

Proceeds will advance the clinical development of MinervaX’s novel GBS vaccine through phase 2 clinical trials, as well as manufacturing and regulatory preparation for phase 3. GBS is responsible for nearly half of all life-threatening infections in newborns. The post Minervax raises €47.4m

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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.

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pharmaphorum

AUGUST 17, 2020

It also has a therapy called K-NK003 in early-stage clinical development for patients with acute myeloid leukaemia (AML). Kiadis says that in COVID-19, the NK immune response becomes impaired, and in severe cases patients may have no functional NK cells at all.

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The Pharma Data

AUGUST 6, 2020

It signed a manufacturing and distribution agreement with R-Pharm in Russia and tapped the Serum Institute of India to provide for low-income countries. South Korea’s SK Bioscience recently joined AZ’s COVID-19 vaccine manufacturing network, and Daiichi Sankyo stated in late June that it’s in discussions to supply the shot in Japan.

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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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XTalks

MARCH 13, 2023

Another thing Dr. Xu recommended is to monitor the immune response to gene therapy products. Immune assays were recommended to measure both cellular and human immune responses to the viral vector and the transgene, as applicable.

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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. The joint development team is working on improving the temperature stability of the mRNA vaccine candidate and targeting a -20°C storage temperature for late-stage clinical trials and at launch.

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The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.” About CEPI.

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The Pharma Data

JANUARY 21, 2021

The compound was developed in the laboratory of Richard Childs, chief of the Laboratory of Transplantation Immunotherapy with the National Heart, Lung, and Blood Institute (NHLBI). The National Institutes of Health (NIH) is planning on taking over manufacturing and clinical development.

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The Pharma Data

JANUARY 17, 2021

REX-001, Ixaka’s lead MCT product, is an autologous cell-based product in clinical development for the treatment of CLTI. REX-001 is currently being evaluated in the pivotal Phase III SALAMANDER clinical trial at multiple sites across Europe. For more information, please visit www.ixaka.com.

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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.

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The Pharma Data

JANUARY 19, 2021

Qilian International – Jiuquan, China-based Qilian International holding Group Limited, a pharmaceutical and chemical products manufacturer, announced its IPO of 5 million ordinary shares at $5 per share on January 14. The National Institutes of Health (NIH) is planning on taking over manufacturing and clinical development.

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pharmaphorum

JANUARY 31, 2022

At Pfizer and BioNTech, this was accomplished by creating cross-functional teams from multiple departments, so that R&D, medical, commercial, manufacturing, supply chain, and digital innovation experts were all working together at the same time. The COVID-19 vaccines were brought to market faster than any other vaccines in history.

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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

OCTOBER 27, 2020

Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinical development as a monotherapy and in combinations. MRTX1133 is an investigational small molecule and selective KRAS G12D inhibitor in preclinical development.

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Pfizer

JULY 19, 2022

The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 1 as compared to the companies’ current COVID-19 vaccine.

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The Pharma Data

DECEMBER 11, 2020

A breakdown of the diversity of clinical trial participants can be found here from more than 150 clinical trial sites in the U.S., 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.

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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)

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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

DECEMBER 20, 2020

“We are encouraged by the data shown in these two studies of GPS in combination with checkpoint inhibitors and look forward to additional data from these studies,” stated Dragan Cicic, MD, Senior Vice President, Clinical Development of SELLAS. “We Kenilworth, N.J., Keytruda ® is a registered trademark of Merck Sharp & Dohme Corp.,

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Pfizer

JULY 8, 2022

Following a third dose in this age group , the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. Some people with weakened immune systems may have reduced immune responses to Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA).

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The Pharma Data

DECEMBER 27, 2020

Our work began modestly, but we hit our stride in 2020 and reached important clinical, manufacturing, and business milestones this year, which created substantial value and advanced us toward our ultimate goal. Our goal of building Lineage into the preeminent cell therapy company is ambitious but attainable.

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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

This includes the most recent analyses from the pivotal Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose. 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

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. Senior Vice President and Head of Global Clinical Development at Regeneron. Yancopoulos , M.D., combined dose groups; 6.5%

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The Pharma Data

DECEMBER 29, 2020

(NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. Senior Vice President and Head of Global Clinical Development at Regeneron. futility analysis). .

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Pfizer

JULY 8, 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. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

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The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” and Roche will develop, manufacture and distribute it outside of the U.S.

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The Pharma Data

DECEMBER 10, 2020

A breakdown of the diversity of clinical trial participants can be found here from approximately 150 clinical trials sites in the U.S., 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.

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XTalks

AUGUST 18, 2021

Of important note is the aberrant immune response that occurs in patients with COVID-19, including the intensive release of cytokines (cytokine storm), which can make a patient infected with SARS-CoV2 more susceptible to contracting a bacterial respiratory infection. So, what can we be doing now to prevent the next pandemic?

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

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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.

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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. About AstraZeneca. AstraZeneca.

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The Pharma Data

JUNE 2, 2022

A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development. We look forward to working with the many talented people at Affinivax to combine our industry-leading development, manufacturing, and commercialisation capabilities to make this exciting new technology available to those in need.”

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