Info & Opinion
September 3, 2015
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
PPD reported quarterly financial results. Service revenue rose 7 percent, to $339.4 million. Profits edged fractionally higher, by less than a single percentage point, to $38 million. "Contract cancellations and adjustments for the quarter were $220.9 million, including two large project cancellations that together totaled $92.8 million," the company said in a news release.
PercepEnz Technologies has changed its name to Forte Research Systems. The Madison, Wisconsin based firm offers systems for clinical trial management and biospecimens; some of its technology is aligned with the National Cancer Institute's caBIG agenda.
Could the hype about apps be a bit overdone? Of the mobile phone users with small applications on their handsets, just two thirds actually use the cute programs. Just as most people use computers for email, word-processing and web browsing, people seem to use mobile phones to (surprise!) make calls. Here's an article in the Online Media Daily.
McKinsey & Co., the fabled consulting firm, has been retained by the FDA to assess whether the agency can reduce a towering pile of 2,000 generic drug applications awaiting review in Washington. Our heart goes out to anyone wading into that situation. Here's a short item in FDA News.
The Regulatory Affairs Professionals Society (RAPS) released an e-book with relevant industry rules. Fundamentals of US Regulatory Affairs may not be as riveting as something by John Grisham, but RAPS says it will work on the Apple iPad and readers from Amazon and Barnes & Noble. Best of all, there are links taking the reader to relevant documents online. The price ranges from $235 to $400 depending on whether you are a RAPS member and need a companion hard copy.
Life science investors should brace themselves for consistently lower numbers of FDA approvals. That's been on the grapevine for a while. Now consultants at Parexel have tried to quantify the trend, citing "a 25 percent decline in first-cycle approval rates for priority-rated new drugs and a 17 percent decrease in priority designations for new drug applications (NDAs)," the company said in a release. "Our analysis of the latest FDA metrics leads us to ask whether there is a 'new normal' emerging, which has significant implications for the drug-review process," said Mark Mathieu, director of strategic research in the firm's consulting arm. The white paper is available at no charge on the company's website. We're hoping to learn whether fewer approvals are resulting from lower industry research productivity, more lengthy FDA reviews, or both dynamics in tandem.