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Digital tools driving innovative clinical trials

pharmaphorum

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use. Source: Izmailova et al, 2017.

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Incannex engages QPS for CannQuit and ReneCann

Pharmaceutical Technology

The company will provide regulatory advice to Incannex, and manage clinical trials to develop CannQuit and ReneCann products to treat addiction and immune-disordered skin diseases. QPS was established in 1995 to provide bioanalytical LC-MS/MS contract services.

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(Lopinavir + ritonavir) by Douglas Pharmaceuticals for Genital Warts (Condylomata Acuminata): Likelihood of Approval

Pharmaceutical Technology

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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(Lopinavir + ritonavir) by Douglas Pharmaceuticals for Cervical Intraepithelial Neoplasia (CIN): Likelihood of Approval

Pharmaceutical Technology

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Nektar and PureTech merger talks called off

pharmaphorum

In a statement , PureTech said it had been required to go public with the talks once they started to be reported in the media to comply with UK financial regulations, but said this morning that they “were early in nature and the required announcement created the impression that discussions were more advanced than they were.”

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

pharmaphorum

Kintor posted a press release at the end of April to announce that phase 3 clinical development had begun and since then it has seen its share price rise considerably on the Hong Kong stock exchange. But Reuters reported that the doctor identified as its principal clinical trial investigator has said he is not in charge of the trial.

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FDA turns down Amryt’s epidermolysis bullosa drug

pharmaphorum

Amryt Pharma has been handed a major blow by the FDA, after the US regulator rejected its marketing application for Oleogel-S10, its drug for rare and debilitating skin disease epidermolysis bullosa (EB). pic.twitter.com/NzhGx1q1o8. — debra of America (@debraOfAmerica) February 28, 2022.

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