Drugmakers received the first slice of FDA social media guidance in January, and now the FDA's mailbag is filling up with letters on First Amendment protections, "jurisdictional creep" and other topics from the likes of Pfizer and PhRMA.
Europe is embarking on the second, decadelong part of its public-private partnership to improve drug development, with Parliament agreeing this week to contribute to the €3 billion ($4.1 billion) program. And the "yes" vote will mean more cash for IT.
John Chen has begun refocusing BlackBerry on healthcare and other industries with specialized requirements. And evidence of just how deep BlackBerry plans to get into healthcare emerged this week when the company outlined plans for a smartphone tailored to the industry.
British government funding groups are looking for startups that will sustain the resurgence in the country's economy. And that means more money for bioinformatics businesses, with the Technology Strategy Board accepting applications for new funding from next month.
Every clinical trial has its outliers. Some patients respond far better to the treatment than the rest, but the focus on efficacy across the study population means these results--and their implications--are lost in the shuffle. The National Cancer Institute is trying to change this by improving the tracking of data on these "exceptional responders."
While it is years now since clinical trial participants started talking about their experiences online, the industry is still searching for the best way to approach the phenomenon. And with pharma needing to improve the clinical trial process, the onus is on the industry to find systems that not only manage the negative implications of social media, but tap into its power, too.
The parents of a teenage boy who died of glioblastoma multiforme are trying to build a database of 50,000 human genomes.
The Open Source Drug Discovery program India set up in 2008 promised to disrupt the current model and deliver new treatments for neglected diseases. Six years later, OSDD is still working towards these goals, but has run up against shortages in two age-old areas: Money and skills.
A lot has changed in clinical trial transparency since Project Data Sphere outlined plans to share cancer results in 2012, with the European law voted in last week then still a distant threat. Even so, Pfizer, Sanofi and the other groups behind the initiative think it still offers something different now that it has belatedly launched.
Genentech has a long history of incorporating real-world data into its business, with the myocardial infarction registry it helped set up in the 1990s showing how to achieve better patient outcomes using its drug Activase. And the big biotech has now teamed with PatientsLikeMe to access patient-focused data and research tools.
The European campaign for greater clinical trial data transparency faced a big test this week when the region's politicians voted on legislation. More than 95% voted in favor of the regulations, paving the way for the creation of a publicly-accessible database of clinical trial results.
The IPO was priced at $20 a share--above the midpoint of the range--and rose when trading began on Friday.
Having invested in data analytics platforms in recent years, pharma R&D labs are working to develop the drugs that will justify their spending. But the experience of Merck suggests the costs can be spread across the business, with manufacturing teams finding the data analytics tools as useful as their peers in R&D do.
The features of Berg Pharma's discovery platform read like a bingo card of hyped approaches, with Big Data sitting alongside genomics and artificial intelligence. Berg has tried to push expectations higher still by claiming it can halve drug development time and costs, but to date the claims--like some of the technologies on which they are based--remain unproven.
It is almost four years since Facebook passed 500 million users. And while the role of it and other social media in clinical trials has generated lots of media coverage and conference chatter, the industry is yet to fully embrace the tools. Survey data published this week show just how there is to go.
Last month Pfizer and the Broad Institute published details of their work to find diabetes drug targets in genome data. Now Pfizer has teamed with Merck KGaA to give the institute another pot of cash to investigate lupus.
Over the past 18 months the National Institutes of Health has taken multiple steps to get a grip on spiraling Big Data challenges, but the initiatives are still taking shape. And the agency is seeking the input of the genomics, bioinformatics and broader medical communities to help finalize its plans.
Duke is setting up an applied genomics and precision medicine center as part of the reshuffle.
The expansion of whole-genome sequencing into clinical care has intensified discussions about the limitations of the technology. Illumina CEO Jay Flatley this week acknowledged sequencing still has some weaknesses and identified what he sees as the solution--improved bioinformatics.
The combination of genomics and bioinformatics expertise now needed for target validation has led drugmakers to look outside their walls for skills, with Pfizer teaming with the Broad Institute on such a project. Now GlaxoSmithKline has set up its own initiative and called for its Big Pharma peers to get involved.