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CytoDyn scores $12M in legal battle win: A huge breakthrough for its antibody drug trials

BioPharma Reporter

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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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.

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Scepticism in press over Kintor’s COVID-19 US drug trial

pharmaphorum

China’s Kintor Pharmaceutical has begun late-stage US clinical development of its potential COVID drug proxalutamide – but there is scepticism over the company’s claims about its research. Kintor is in talks with the Brazilian health regulator Anvisa about a further trials.

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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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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.

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How does HTA for orphan drugs differ across Europe?

pharmaphorum

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.

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LQTT secures $19M; Nanox acquires Zebra Medical Vision; Takeda leads IBD drugVisus raises $20M

Delveinsight

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.

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