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Merck Drops Late-Stage Cancer Drug Trial Due to Disappointing Efficacy | 2021-01-20

The Pharma Data

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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Florida woman jailed for lying to FDA about children's drugs trial

Outsourcing Pharma

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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This week in drug discovery (30 Oct-3 Nov)  

Drug Discovery World

News round-up for 30 October – 3 November by DDW Editor Reece Armstrong My news highlights this week feature a variety of exciting clinical trial results and launches that are examining therapies for much-needed disease areas, new drug approvals and even a space mission with a pharma twist.

Drugs 52
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Study coordinator pleads guilty to trial data falsification

Outsourcing Pharma

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.

Trials 98
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Top Three Reasons Why Your Medical Device Needs a Clinical Trial

Advarra

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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Steps to building a more patient-centric industry

pharmaphorum

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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How does HTA for orphan drugs differ across Europe?

pharmaphorum

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.

Drugs 116