BioPharma Reporter

JULY 11, 2024

Amid a period of clinical holds and legal tangles, the US antibody specialist CytoDyn has reached a settlement to resolve legal disputes with its former contract research organization (CRO) Amarex Clinical Research.

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BioPharma Reporter

OCTOBER 24, 2024

The negative trial results have tanked the California-based biotechâs market value, with a 70% reduction in share price over the last week.

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Drug Trials Trials Drugs Marketing 59

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 95

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

pharmaphorum

AUGUST 4, 2020

Several factors make it difficult for HTA bodies often to assess orphan drugs, including a lack of robust trial data due to difficulties in finding patients, the absence of randomised controlled trials, the use of surrogate endpoints, and the lack of active drug comparators. Source: CRA Analysis.

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Drugs Manufacturing Marketing Regulation 122

Outsourcing Pharma

JANUARY 16, 2023

A Florida doctor has been sent to prison after submitting a false affidavit claiming she had screened children in a clinical study looking at the effectiveness of drugs given to children with asthma when she had not.

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Drug Trials Doctor Doctors Drugs 59

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?

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Clinical Trials Clinical Trials Trials Production 52