AstraZeneca Acquires Acerta

Posted on 26. Jan, 2016 by .

AstraZeneca recently announced that it has entered into an agreement to invest in a majority equity stake in Acerta Pharma, a privately-owned biopharmaceutical company based in the Netherlands and US founded in 2012. The transaction provides AstraZeneca with a potential best-in-class irreversible oral Bruton’s tyrosine kinase (BTK) inhibitor, acalabrutinib (ACP-196), currently in Phase III development [...]

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What Does All This Data Really Mean?

Posted on 19. Jan, 2016 by .

The time has finally arrived or is very close. It is now possible to obtain real-time health data from sensors embedded into everything from our iWatches to Fitbits and even sewn into clothes. Doctors, medical clinics and life science companies can now obtain real-time data on patients who are “in-the-field.” We don’t have to rely [...]

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Mega-Merger Looked Upon Unfavorably by Many But Not All

Posted on 11. Jan, 2016 by .

The recently announced mega-merger between Pharmaceutical companies Pfizer and Allergan has caused quite a stir.  The deal is for a record-breaking sum of over $150 billion dollars. It is being called a “reverse” merger or, as it is commonly called, an inversion.  An inversion is the process by which a U.S company looks to lower [...]

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Clinical Trials of Video Games? Yes.

Posted on 04. Jan, 2016 by .

The technology company Akili, located in Boston, is attempting to validate its scientific claims about the efficacy of game-based interventions through the FDA clinical trial process. Akili functions on the premise that advances in neuroscience research and consumer-facing technology are enabling a new way to sensitively measure neural function, and intervene in any measured deficits, [...]

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FDA Proposes to “Step Up” Oversight of Laboratory Developed Tests

Posted on 28. Dec, 2015 by .

In a recent report released by the FDA titled, “The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies,” a strong case is made by the FDA for them to increase oversight of Laboratory Developed Tests (LDTs). A laboratory developed test (LDT) is a type of in vitro diagnostic test that [...]

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As Flu Season Kicks In, FDA Takes Action

Posted on 21. Dec, 2015 by .

According to the Centers for Disease Control and Prevention (CDC), in recent years, it is estimated that 80 to 90 percent of seasonal influenza-related deaths and 50 to 70 percent of seasonal influenza-related hospitalizations have occurred among people 65 years of age and older. This is part of the reason why the FDA has recently [...]

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How to “Globalize” GMP Training

Posted on 17. Dec, 2015 by .

As reported back in November by In-Pharma Technologist, Sandoz was cited by FDA for providing English-language materials to workers in Mumbai who did not read English. We have had many conversations with our Life Science clients about their global training challenges, and language issues continue to be one of them. This issue will only become [...]

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Industry Involvement in Research a Problem

Posted on 14. Dec, 2015 by .

A study published in the Journal of Clinical Epidemiology revealed heavy-handed involvement of pharmaceutical firms in research studies. The abstract from the study called, Meta-analyses with industry involvement are massively published and report no caveats for antidepressants, is below. We identified 185 eligible meta-analyses. Fifty-four meta-analyses (29%) had authors who were employees of the assessed [...]

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