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FDA finalizes guidance on integrating EHRs into clinical trials
fiercebiotech
July 31, 2018
The FDA recently finalized an eagerly awaited guidance on the incorporation of electronic health records and real-world data into clinical trials and product submissions, including the use of patient medical histories.....
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Outsourcing aids microbiology testing market to grow at 6.4% CAGR by 2023
europeanpharmaceuticalreview
July 16, 2018
The global clinical microbiology market is projected to reach USD 4.95bn by 2023 from USD 3.63bn in 2018, growing at a CAGR of 6.4% from 2018 to 2023.
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Ionis-backed Dynacure bags €47M to start clinical trials
fiercebiotech
July 09, 2018
Dynacure has raised €47 million ($55 million) to take an antisense oligonucleotide therapy into the clinic. The French biotech picked up the centronuclear myopathy (CNM) prospect from its cofounder, Ionis Pharmaceuticals.
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Phase II Clinical Trials of DCVAC Show Significant Benefit for Patients with Ovarian and Lung Cancer
b3cnewswire.
June 04, 2018
SOTIO, a biotechnology company owned by the PPF Group, presented results from its Phase II clinical trials evaluating DCVAC
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ASLAN prices IPO of its American depository shares
biospectrumasia
May 08, 2018
Leerink Partners and Piper Jaffray & Co. are acting as joint book-running managers for this offering.
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Why Choose a Site Network for Your Clinical Trials?
fiercebiotech
May 08, 2018
With an established operational management system, the site network optimizes daily flow in the clinics, especially given that the flow is dedicated solely to research-related activities.
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UCB and Science 37 partner up for virtual, siteless clinical trials
fiercebiotech
May 07, 2018
UCB announced it will work with Science 37 to bring clinical trials out of brick-and-mortar research sites and into participants’ homes. By using telemedicine, real-world data and outcomes reported by patients via a mobile device...
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Not enough women included in some heart disease clinical trials
worldpharmanews
May 03, 2018
Women are underrepresented in clinical trials for heart failure...
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Xultophy® shows significant results for type 2 diabetes patients in real-world setting
pharmaasia
December 19, 2017
Xultophy® by Novo Nordisk has been shown to significantly reduced blood sugar levels in people with type 2 diabetes after six months.
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China to accelerate new drug approvals by incorperating overseas trial data
pharmafile
October 10, 2017
In a bid to speed up access to medicines for patients, China has revealed it intends to incorporate data from clinical trials conducted overseas into its approval process for new drugs.