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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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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Pfizer

FEBRUARY 16, 2023

The clinical trial remains ongoing with other sites not operated by the third party, and Pfizer continues to enroll new participants at those sites. 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.

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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. It may also allow for priority or rolling review of a company’s Biologics License Application (BLA).

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The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. 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

JANUARY 27, 2021

. A total of 15 patients have been recruited to date in the Phase I dose escalation part of the study, all of whom were late stage and have failed conventional treatments, including several lines of rituximab-containing therapies. ET ) to discuss the results and next steps in clinical development of BI-1206.

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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

JANUARY 19, 2021

technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinical development pipeline or for additional licensing and partnering. The Company’s validated, proprietary F.I.R.S.T

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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

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) approval. PharmaDrug Inc.

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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

DECEMBER 14, 2020

The Company anticipates using net proceeds from the offering to fund the continued development of ublituximab and umbralisib, the potential in-license, acquisition, development and commercialization of other pharmaceutical products, and for general corporate purposes. Morgan Securities LLC, Goldman Sachs & Co.

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The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. 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 May 6, 2021.

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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

JANUARY 18, 2021

Proceeds from the financing will support the advancement of Vera’s lead clinical candidate, atacicept, a novel inhibitor of B cells and plasma cells, in patients with IgA nephropathy (IgAN). Vera is on track to start a Phase 2b study in IgAN patients in mid-2021 and is investing in commercial-scale manufacturing capabilities.

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The Pharma Data

OCTOBER 26, 2020

Fast Track designation allows for early and frequent communication with the FDA throughout the entire drug development and review process. It may also allow for priority or rolling review of a company’s Biologics License Application (BLA).

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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

OCTOBER 19, 2020

“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. About Pneumococcal Disease.

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The Pharma Data

NOVEMBER 22, 2020

In parallel, Cytokinetics plans to conduct commercial readiness assessments and to evaluate potential partnering opportunities, including co-promotion options in North America as well as licensing in other territories. Cytokinetics will have no trailing royalty payment obligations to Amgen for either omecamtiv mecarbil or AMG 594.

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The Pharma Data

JANUARY 25, 2021

The Company will manufacture and supply Hexvix, and receive a transfer price from Asieris representing a markup on product provided under the Agreement. but with a healthcare system that is still developing. million for the achievement of certain regulatory milestones including market approvals in Mainland China and Taiwan.

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The Pharma Data

AUGUST 20, 2020

The totality of the clinical and preclinical data informed Pfizer and BioNTech’s decision to select BNT162b2 as the lead candidate to advance into pivotal trials. 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

JANUARY 13, 2021

Complete approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials. . Our 5,000+ employees in China, the United States, Australia, Europe, and elsewhere are committed to expediting the development of a diverse pipeline of novel therapeutics. About BeiGene.

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The Pharma Data

NOVEMBER 9, 2020

Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced. The information contained in this release is as of November 9, 2020.

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The Pharma Data

JANUARY 18, 2021

This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc. ZTlido ® was approved by the FDA on February 28, 2018. For more information visit www.sorrentotherapeutics.com. Forward-Looking Statements.

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The Pharma Data

OCTOBER 30, 2020

REGN-COV2’s development and manufacturing has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. and Roche will develop, manufacture and distribute it outside the U.S.

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The Pharma Data

DECEMBER 10, 2020

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 December 10, 2020. Pfizer Disclosure Notice.

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The Pharma Data

JANUARY 13, 2021

.” MindMed Chief Development Officer Rob Barrow said, “Psychedelic therapies offer a once in a lifetime opportunity to revolutionize the delivery of mental healthcare.

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Drug Discovery World

MARCH 29, 2023

Peter O’Donnell, Applied Clinical Trials’ Brussels Correspondent, summarises this as the EMA being tasked with creating a European network of patient representatives, academics, drug developers, investigators, and centres with expertise in the performance of studies in the paediatric population.

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FDA Law Blog

SEPTEMBER 20, 2021

Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments. The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries.

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The Pharma Data

OCTOBER 27, 2020

Orphan Drug designation affords Passage Bio the potential for certain benefits, including up to seven years of market exclusivity, assistance in the drug development process, tax credits for clinical development, and exemptions from certain FDA fees. More information is available at www.passagebio.com.

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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 This press release contains forward-looking statements. Kenilworth, N.J.,

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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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Pfizer

JULY 26, 2022

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in individuals 6 months of age and older. The information contained in this release is as of July 27, 2022. Emergency Use Authorization .

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The Pharma Data

OCTOBER 28, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron. REGN-COV2’s development and manufacturing has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S.

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The Pharma Data

DECEMBER 29, 2020

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. Evaluation of its safety and efficacy is ongoing in multiple clinical trials. Under an agreement with the U.S. In the U.S.

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The Pharma Data

NOVEMBER 5, 2020

Key Pipeline Progress Regeneron has more than 20 product candidates in clinical development, including five marketed products for which it is investigating additional indications. Updates from the clinical pipeline include: Dupixent ® (dupilumab). Corporate and Business Development Update. Business Highlights.

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