President Trump has had big pharma in his sights for some time. As his presidency continues, more has emerged about the administrations plans to tackle an industry that Trump has suggested has gotten away with murder . The latest proposals an International Pricing Index amount to inte Powered by WPeMatico Continue reading International Reference Pricing, US Style
Paul Glimcher In a sign of the increasing role real-world evidence (RWE) will have in healthcare research, FDA recently announced a $100 million proposal to build a modern system to gather RWE from about 10 million individuals. The good news is that this could transform clinical trials Powered by WPeMatico Continue reading FDA’s $100 Million Real-World Evidence Project: Making It All It Can Be
In publishing its proposed rule on disclosing drug prices just three weeks before the November mid-term Congressional elections, it s not a big stretch to regard the move by the Trump administration as designed primarily for short-term political purposes and not to better inform the American p Powered by WPeMatico Continue reading Politics Drives DTC Price Disclosure Rule
President Trump has suggested that the FDA process for drug approval is slow and burdensome. Yet use of the FDAs options for speedier regulatory approval applied to more than half of novel drug approvals in recent years, but just what drugs and from which companies are being approved faste Powered by WPeMatico Continue reading Big Companies Driving FDA Fast Lanes
There s been a lot of talk about speeding up drug approval at FDA, especially from President Trump. So just how fast can approval be? In another in a series to explore the expedited FDA approvals, Leela Barham takes a look at the speed of approval for each of FDA’s expedited development a Powered by WPeMatico Continue reading How Fast are the FDA Fast Lanes?
The critical need for new medicines to combat infectious diseases that fail to respond to current medical treatment is prompting FDA to join with other federal health agencies and the biomedical research community to advance the science, regulatory policies and reimbursement strategies to suppor Powered by WPeMatico Continue reading FDA Launches Major Push for New Antimicrobials
With the rise in industry programs for developing biosimilars, tensions are high as innovator firms back strategies that appear designed to delay competition. Key regulatory issues under review: testing requirements to document interchangeability; product naming to distinguish biosimilars from r Powered by WPeMatico Continue reading Biosimilars Battles Heat Up
Given the crucial role that health technology assessment (HTA) has acquired in the increasingly tense debate on drug prices and the related issues of the value of medicines and access to care, it comes as something of a surprise to learn that there is still no agreement on just what HTA is. But Powered by WPeMatico Continue reading Who Knows What HTA Really Is?
Just as biopharma companies are mastering the complexities of the five-year-old federal Open Payments program, state governments are enacting a host of additional marketing and disclosure rules and restrictions on industry interactions with health care professionals (HCPs). This stepped-up actio Powered by WPeMatico Continue reading States Expand Transparency & Disclosure Requirements
AI adoption by pharmaceutical companies demands a new, agile governance layer, write Tim Wright and Antony Bott. Tim Wright The convergence of big data, cloud computing, artificial intelligence (AI) and its subsets, machine learning and deep learning, offers pharmaceut Powered by WPeMatico Continue reading Pharma AI Requires a New Approach to Governance