Info & Opinion
April 25, 2019
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
Icon reported sharply lower quarterly earnings. Net service revenue for the period rose 4.5 percent, to $243 million. Profits fell 81 percent, to $4.1 million. CEO Ciaran Murray put the results in a positive light: "I am encouraged with our performance in the quarter. Net new business awards were $308 million." Here are the numbers.
The FDA published a draft guidance on standardizing electronic data. The agency appears to have no plans for any new mandates for industry. The document does mention the Clinical Data Interchange Standards Consortium (CDISC), but makes it clear that several types of standards—for analysis, terminology, data and computer files—are elements of what U.S. officials will need internally. "It is impossible or impractical to define a priori all the relevant validation rules for any given submission," the document states. Vendors and sponsors will be free to continue to create unique, nonstandard datasets for each FDA submission. That will give industry important flexibility but also make it all but impossible for industry's research systems to be readily connected to federally subsidized physician and hospital computers.
Altheos has begun recruiting patients for a two-stage adaptive Phase II trial in a glaucoma drug licensed from Japan. "A ROCK inhibitor, which works through a mechanism of action unlike any drug currently available, is an exciting option,” said Barbara Wirostko, an ophthalmologist and Altheos's chief medical officer. “ATS907 was selected for development based on data demonstrating properties that were optimal for ocular administration." Here's a release.
With average annual salary increases of 12 percent, pharma paychecks in India are expected to rise faster than those in other industries. That's the news from a survey by human resources firm Aon Hewitt. Salaries in Indian financial services and telecommunications companies are looking less than rosy.
Quintiles is expanding and partnering in the Middle East. It signed a deal with Dayam Pharma, which is based in the United Arab Emirates and has no easily located website. The contract research organization (CRO) says the utilization rate for pharmaceutical products is projected to double in the region. Said James Featherstone, senior VP of commercial services at Quintiles: “There is significant growth in the Middle East and North Africa market, with Saudi Arabia, UAE, Algeria and Egypt standing out as the largest markets in terms of projected growth potential. There is strong demand for services in the region from our biopharma customers seeking to expand their geographic footprint while minimizing risk." Here'a a release.
DePuy, a top JNJ medical device division, is quietly sparing with the news media and lawyers in thousands of lawsuits for a metal-on-metal artificial hip pulled from the market two years ago. The story has parallels to the Vioxx saga: most of the details are emerging from channels other than the medical literature or official FDA communications. The company continued selling a product in a period when internal documents and private FDA communications showed serious safety issues. And no matter what happens in court, the company will see an impact to its reputation. The NYT has published a JNJ email that appears to contradict other statements by the company. JNJ notes it was within the law to continue to sell the hip while the clinical data were evaluated. It's not clear how many U.S. patients received the hip while the company reviewed its options, but the news organization estimates the number at 30,000.