How Important is Data Integrity to Regulatory Bodies?
21 March 2016
D3Damon/Getty ImagesData integrity is a major regulatory topic in GMP-regulated laboratories. The problem is widespread, as cases of non-compliance have also been observed in laboratories regulated by good laboratory practice (GLP) and good clinical practice (GCP), not just GMP. Non-compliances from the European Medicines Agency (EMA) or warning letters from FDA show examples from companies in the United States, Canada, the United Kingdom, and Italy, as well as China and India. So, it is not just a problem for Asia—it is a global issue.
Tearing down barriers to cooperation with strengthened intellectual property protections
18 March 2016
Robert Frost once wrote, “Good fences make good neighbors.” To make good neighbors, Frost suggested that we need to respect the boundaries that exist between us. But what if it’s actually the walls that alienate us from one another? And what if, to truly make good neighbors, we must tear down the barriers in order to promote better cooperation?
No One Likes the Medicare Part B Pilot
18 March 2016
This time, doctors and oncologists agree with pharma companies in opposing the latest proposal from the Centers of Medicare and Medicaid Services (CMS) to revise how it pays for drugs administered in doctors’ offices. Similarly, many patient advocates fear that ceilings on drug prices will curb access to newer therapies, and leading Republicans have rebuked the plan.
Four trends that will transform healthcare in Europe in 2016
18 March 2016
With 2015 giving some hints of what is to come, the Kaiser Associates European Healthcare team are predicting another year of big disruptions, transformations and innovations as the healthcare industry continues to overhaul outmoded business models.
Achieving Cost-Effective Bioprocesses
17 March 2016
BullStorm/Getty Images; Dan WardAlthough many of the newest methods to optimize process economics focus squarely on the implementation of single-use systems and the realization of continuous processing, there are other methods of cost cutting that could help a bioprocess become more sustainable. Operators should look to methods to optimize the use of solvents, get the most from their resins, explore hybrid approaches and miniature bioreactors for improved process understanding, and investigate alternatives to mammalian vectors to improve cost calculations.
Generic-Drug Production and Oversight Challenge FDA and Manufacturers
17 March 2016
It’s well known that generic drugs account for 88% of prescription drug sales in the United States and have saved billions for patients and healthcare systems since Congress enacted the Hatch-Waxman Act more than 30 years ago. That growth, though, has created difficulties for FDA in processing the hundreds of resulting abbreviated new drug applications (ANDAs) and in inspecting an expanding number of generic-drug manufacturers and ingredient producers all over the world.
Advertising drives traffic, especially Millennials, to pharma websites: Survey
17 March 2016
Patients today are armed with more information than ever, and they're looking for active roles in their treatment. How can pharma companies make sure they're part of the mix?
Study: The FDA's 'breakthrough' program is speeding up cancer approvals
17 March 2016
Since the FDA unveiled its breakthrough therapy designation in 2012, cancer drugs brought into the program won approval roughly three months faster than other oncology therapies, according to a new study.
BioPhorum Operations Group Invites Industry Stakeholders to Participate in Technology Roadmap
16 March 2016
The BioPhorum Operations Group is inviting industry stakeholders including academics, supply partner R&D heads, regulators, and regional hubs to participate in the group’s Technology Roadmap for the future of biopharmaceuticals.
The most influential people in biopharma today
16 March 2016
Biopharma is in for a transformational year in 2016. Lawmakers are clamoring for drug price reform. Patients are protesting for faster FDA approvals. Patents are under fire from value-seeking hedge funders. And the industry's least-welcome spokesman is live-streaming the whole thing.
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