The Pharma Data

SEPTEMBER 9, 2020

“We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted.”. “As About the Phase 2/3 Study. billion doses by the end of 2021.

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The Pharma Data

NOVEMBER 20, 2020

18 years of age and unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of two months following the second dose of the vaccine candidate. In some cases, governments may have regulatory pathways similar to an EUA. Manufacturing and Delivery Capabilities. About the Study.

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The Pharma Data

JULY 21, 2021

The companies are firmly committed to working towards equitable and affordable access for COVID-19 vaccines for all people around the world, actively working with global governments as well as global health partners with the aim to provide 2 billion doses to low and middle income countries in 2021 and 2022 – 1 billion each year.

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The Pharma Data

MAY 6, 2021

Under the MoU framework, NOCs and their local governments are expected to coordinate the administration of vaccinations to eligible Games participants. Doses provided under this MoU would be in addition to doses provided under supply agreements with governments worldwide.

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The Pharma Data

MAY 7, 2021

Government,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S.

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The Pharma Data

DECEMBER 11, 2020

Government to supply doses in 2020 & 2021. All trial participants will continue to be monitored to assess long-term protection and safety for an additional two years after their second dose. government’s Operation Warp Speed program goal to deliver doses of a vaccine for COVID-19. immediately.

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The Pharma Data

APRIL 27, 2021

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. For more than 170 years, we have worked to make a difference for all who rely on us.

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The Pharma Data

AUGUST 29, 2020

3,4 LNP023 is currently in clinical development for PNH and a number of renal conditions with complement system involvement where significant unmet needs exist, including IgA nephropathy, complement 3 glomerulopathy (C3G), atypical hemolytic uremic syndrome and membranous nephropathy. Blood 2019;134(Suppl 1):3517.

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Treatment Disease Small Molecule Production 52

The Pharma Data

NOVEMBER 5, 2020

Taveras will lead all research and non-clinical development functions supporting the company’s pipeline of investigational therapies. Prior to that, Taveras was vice president of Small Molecule Drug Discovery and CMC Development at Biogen Idec, and Alantos Pharmaceuticals, which was acquired by Amgen in 2007.

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Analytical Chemistry Pharmaceuticals Small Molecule Therapies 40

The Pharma Data

AUGUST 20, 2020

Phase 1 trial for the BNT162b2 vaccine candidate, which at 30 ?g The companies are continuing to analyze data from the Phase 1 trials in the U.S. 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. and Germany.

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The Pharma Data

DECEMBER 1, 2020

This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. will mark the first time citizens outside of the trials will have the opportunity to be immunized against COVID-19,” said Ugur Sahin, M.D., The Emergency Use Authorization in the U.K.

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The Pharma Data

NOVEMBER 9, 2020

Analysis evaluated 94 confirmed cases of COVID-19 in trial participants. Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints. Pfizer Inc.

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Conversations in Drug Development Trends

MAY 30, 2024

Authors: Rich Worldwide Clinical Trials Exec. This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. Director, Therapeutic Area Medical Lead.

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Treatment Small Molecule Clinical Trials Therapies 81

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

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The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. About AstraZeneca. AstraZeneca.

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LifeSciVC

APRIL 27, 2023

Fourteen years on, this corporate experiment has gone far beyond the initial idea, and has established an R&D engine more effective than most big pharma R&D groups at producing best-in-class small molecules against targets that matter in human disease biology. Chapter 1 – An Unreasonable Idea The year was 2009.

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The Pharma Data

OCTOBER 14, 2020

This work may also guide the selection of appropriate participants for clinical trials of COVID-19 vaccines, including future human trials using Tonix’s TNX-1800, a live replicating, attenuated COVID-19 vaccine candidate designed to confer durable T cell immunity.”. President and Chief Executive Officer of Tonix Pharmaceuticals.

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Vaccine Pharmaceuticals Small Molecule Virus 40

The Pharma Data

SEPTEMBER 9, 2020

The study is an event-driven trial. Pfizer and BioNTech are committed to decreasing health disparities in underrepresented populations through the clinical trial process. The companies are also working together with investigator sites and advocacy partners to raise awareness about the importance of participation in this trial.

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Vaccine RNA Clinical Trials Immune Response 52

The Pharma Data

SEPTEMBER 15, 2020

Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1. In the blinded data presented, 50% of trial participants received placebo and 50% received BNT162b2. A Phase 3 trial is ongoing. Protease Inhibitor Program. Rare Disease.

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The Pharma Data

OCTOBER 28, 2020

“Takeda continues to focus on developing potential therapies to treat COVID-19 with, for example, the enrollment of the first patients in the CoVIg-19 Plasma Alliance Phase 3 clinical trial — an outstanding achievement in such a short time. “We Press release ). Press release ). Press release ).

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