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A Lesson in History: Assessing Trial Performance Data for Future Trial Design

H1 Blog

Clinical trial success is a key factor for pharma companies when designing and recruiting patients into trials. This data can also provide guidance in terms of diversifying clinical trials to include different types of population demographics such as age, gender, race, ethnicity, or geographic location.

Trials 52
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Accelerated Approval and Confirmatory Trials: Timing is Everything

The Premier Consulting Blog

However, accelerated approval comes with a condition: sponsors must conduct confirmatory trials to verify the drug’s anticipated clinical benefits using robust outcome measures. Concerns have arisen over delays—sometimes spanning over 7–8 years—that may expose patients to risks before confirmatory trials are completed.

Trials 52
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Ultimovacs ASA Initiates FOCUS Phase II Trial for Universal Cancer Vaccine, UV1, in Head and Neck Cancer Patients Receiving Pembrolizumab

The Pharma Data

The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020. “We Mascha Binder, M.D.,

Vaccine 52
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Metabolite Bioanalysis

Metabolite Tales Blog

Metabolite Bioanalysis in Drug Development: Recommendations from the IQ Consortium Metabolite Bioanalysis Working Group A Metabolite Bioanalysis Working Group comprised of experts from 14 different pharma companies have proposed recommendations around best practice in metabolite bioanalysis during drug development.

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Keeping tabs on Covid-19: Starpharma creates slow release remdesivir nanoparticl…

The Pharma Data

In an effort to slow the spread of the disease and prevent a second wave, pharma companies around the world are continuously looking to advance new methods of treatment. This week’s round up dives into developments from companies based in Australia and the US. Saama Technologies, Inc. , Source link.

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What is the largest CRO in the US?

Vial

Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market. By revenue, the largest CRO in the US was Thermo Fisher Scientific Inc.,

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BioSpace Global Roundup, Oct. 15

The Pharma Data

Priothera will use the funds to progress the clinical development of mocravimod, a modulator of sphingosine 1 phosphate (S1P) receptors, to enhance the curative potential of allogeneic hematopoietic stem cell transplantation (HSCT) for treating AML. 1. -- -->. -- [if lte IE 8]--> . adults age 65 and older.