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Pfizer’s pill cuts COVID deaths and hospitalisations by 90%

pharmaphorum

The phase 3 trial found that Paxlovid – which combines new protease inhibitor PF-07321332 with already-approved HIV drug ritonavir – reduced the risk of hospitalisation or death by 89% when given to newly-diagnosed adults who were at risk of developing severe COVID-19 in the EPIC-HR trial.

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Saliva testing may allow early detection of human papillomavirus–driven head and neck cancers

Scienmag

Philadelphia, September 21, 2021 – Cancer causing high-risk human papillomaviruses (HR-HPV) are responsible for the rising incidence of HR-HPV–driven head and neck cancers (HNC), particularly oropharyngeal cancers (OPC, or throat cancers).

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BlueCloud and VirTrial Collaborate to Launch the First Global Training and Certification Program for Telemedicine Best Practices

VirTrial

Verifiable and accessible in real-time, Investigator sites will also benefit by having employer’s VirTrial certifications as part of their dynamic research ready auditable (HR) GDPRDirectory® commonly used for business and compliance tracking, all from one place.”.

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Update on FDA Advisory Committee Vote on LYNPARZA® (olaparib) Plus Abiraterone and Prednisone or Prednisolone in First-Line Metastatic Castration-Resistant Prostate Cancer

The Pharma Data

Results from the PROpel trial showed a statistically significant and clinically meaningful 34% reduction in the risk of radiographic disease progression or death with LYNPARZA plus abi/pred (HR=0.66 [95% CI, 0.54-0.81]; 0.43]) and OS (HR=0.29 [95% CI, 0.14-0.56]) 0.81]; p<0.001) versus placebo plus abi/pred in patients with mCRPC.

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PFIZER SEEKS EMERGENCY USE AUTHORIZATION FOR NOVEL COVID-19 ORAL ANTIVIRAL CANDIDATE

The Pharma Data

Food and Drug Administration (FDA) includes clinical data from the Phase2/3 EPIC-HR ( Evaluation of Protease Inhibition for COVID-19 in High- Threat Cases) interim analysis. In preclinical studies, PF-07321332 didn’t demonstrate substantiation of mutagenic DNA relations. This submission to theU.S. FDA in October 2021.

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LYNPARZA® (olaparib) Reduced Risk of Death by 32% in Patients With Germline BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer in Phase 3 OlympiA Trial

The Pharma Data

In the key secondary endpoint of OS, LYNPARZA reduced the risk of death by 32% (HR=0.68 [98.5% LYNPARZA is a first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells. 0.97]; p=0.009) versus placebo.

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Why intelligent automation is the future for regulation

pharmaphorum

And make sure your HR, training and communications teams are looped in, informed and armed with the right information and tools to encourage and support adoption. You should drive home the notion of ‘one company’ and keep an eagle-eye out for cowboys building their own rogue programmes.