The Pharma Data

JANUARY 20, 2021

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. There’s absolutely no risk to you.

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Drug Trials Drugs Trials Compliance 52

Outsourcing Pharma

NOVEMBER 1, 2021

A former employee of Tellus Clinical Research in Miami has admitted to charges related to a conspiracy to falsify data on a list of clinical drug trials.

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Trials Drug Trials Clinical Research Drugs 98

pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine. About the author.

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Clinical Trials Clinical Trials Trials Clinical Research 109

Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Production 52

pharmaphorum

AUGUST 4, 2020

New research looks at the factors that speed up and slow down HTA appraisals for rare disease medicines across Europe. Rare diseases drugs have always faced challenges when it comes to HTA approvals, even as governments bring in more regulatory policies that make their path through assessment easier. Source: CRA Analysis.

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Drugs Manufacturing Marketing Regulation 108

Delveinsight

AUGUST 12, 2021

LQTT has a portfolio of in-licensed compounds from Sanofi that prohibit serum/glucocorticoid-regulated kinase 1, or SGK1. That kinase plays a role in inappropriate sodium regulation, a hallmark of arrhythmias like Long QT Syndrome. Upon starting the phase 2 trial in March, Visus targeted the delivery of top-line data in mid-2021.

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Trials Clinical Trials Clinical Trials Regulation 97

The Pharma Data

MAY 17, 2021

Regeneron resumes enrollment in lymphoma drug trials ( Reuters ). Incyte’s vitiligo treatment meets main goal in late-stage trial ( Reuters ). $DNA is once again on NYSE; FDA clears Soliris challenger for the market; Flagship’s thinking big again with eRNA; and more ( Endpoints ).

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Trials Vaccination Vaccine Scientist 52