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The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?

Camargo

When a submission is sent through the FDA’s Electronic Submissions Gateway (ESG), it goes through an automated check of many validation rules, as specified in the Electronic Common Technical Document (eCTD) submission standards guidance. The correct STF file-tags are used for datasets and corresponding data definition files.

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Grand Rounds February 24, 2023: S2302 Pragmatica-Lung: New Directions for Decreasing Burden and Increasing Inclusion in NCTN Clinical Trials (Konstantin Dragnev, MD; Karen Reckamp, MD, MS)

Rethinking Clinical Trials

The study does not include tissue specimen collection, image submission, or patient-reported outcome instruments. S1800A was a Phase II randomized study of ramucirumab plus pembrolizumab versus standard of care for NSCLC patients previously treated with immunotherapy performed within the Lung-MAP platform.

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3 ways pharma marketers can draw inspiration from digitally-native brands

pharmaphorum

Pharma’s go-to-market strategies have tended to be more traditional than those seen in non-regulated sectors, but there are some signs this is changing, with an acceleration in the pace of change forced by the COVID-19 pandemic that is allowing the industry to close its gap with faster, more nimble consumer brands. Jeremy Richter, Tag.

Branding 114
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Clover biopharmaceuticals raises $230 M; BrainStorm after ALS; BARDA grants $5.65 M LightDeck for SARS-CoV-2 antigen test; Libtayo for first-line advanced NSCLC subset

Delveinsight

The company plans to use the capital to expand its pipeline of protein-based vaccines and biologic cancer therapies utilizing its innovative and proprietary Trimer-Tag technology platform. BrainStorm Receives Feedback on BLA Submission for ALS. Libtayo for First-line Advanced Non-small Cell Lung Cancer Subset.

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PentagonFit Fitness Tracker

The Pharma Data

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PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

The favorable impact in first-quarter 2021 from selling days was partially offset by the non-recurrence of favorable impacts related to COVID-19 on first-quarter 2020, including increased demand for certain products of approximately $150 million and additional wholesaler inventories of approximately $100 million. in December 2019; and.