Cortellis Regulatory Intelligence

Orphan drug access varies across multiple markets

European countries differ in their value assessment of new orphan drugs, but steps can be taken to create a more harmonized, comparable and rational evidence-based decision-making system in Europe, two experts from the London School of Economics Health reported at the Ninth Orphan Drug Congress 2018. The presentation by Aris Angelis and Panos Kanavos covered […]

Device industry looks to cut time to market

German medical device companies are growing concerned that the approval process in Europe for bringing innovative products to market is taking too long, especially when compared with the U.S., according to a survey conducted by the German medical technology association. In Australia, meanwhile, the Therapeutic Goods Administration (TGA) reported shorter approval timelines for new devices […]

Big data: The future in healthcare is sooner than we think

Data is, of course, driving the future of healthcare. Stakeholders across the industry have been widely preparing for the Big Data transformation and how to put the data to best use. At the recent Financial Times Global Pharmaceutical and Biotechnology Conference titled “Embracing Disruption for a New Era in Health,” several experts examined how to […]

New medical device regulations: The view from Europe

The increased globalization of the medical device landscape was a recurring theme as the industry gathered in Philadelphia for the MedTech Conference this fall. Sessions looked at recent regulatory and business developments in several key markets including Brazil, China, India and the U.S. Here is a look at one important panel discussion that took place […]

U.S. enhances malaria-fighting toolkit

In an unusual action, the U.S. Food and Drug Administration (FDA) asked an advisory committee to meet twice in two weeks this past summer to discuss nearly identical products with similar indications from two different pharmaceutical companies. During their vote, committee members noted the global need for additional agents for the prevention of malaria.   […]

Nanotech medical device makers seek guidance in uncertain regulatory environment

There is little in the way of regulatory harmonization regarding nanotechnology regulation at this point, which leaves makers of devices and diagnostics with a complicated path to market. Some jurisdictions are farther along than others, but to date, none of them have covered as much ground as the U.S. Food and Drug Administration (FDA).   […]

Is Europe’s PRIME program meeting its objectives?

Since the PRiority MEdicines (PRIME) program scheme was introduced two years ago, more than 40 products have been granted PRIME designation.1  In August 2018, the first two therapies with PRIME designation were granted marketing approval by the European Commission (EC) – Novartis’s Kymriah (tisagenlecleucel) and Kite Pharma/Gilead’s Yescarta (axicabtagene ciloleucel). Yescarta and Kymriah are both […]

Global issues stir debate at the 2018 MedTech Conference

News from the global stage resonated throughout the MedTech Conference as the industry gathered in Philadelphia for AdvaMed’s annual meeting.  Among the liveliest sessions were those focused on the future of the clinical trials landscape in the U.K. as a result of Brexit, the impact of trade wars on the industry, and Jeff Shuren, the […]

Med-techs extend borders seeking new opportunities

Medical device companies, eager to drive growth, are now increasingly seeking new opportunities – and approvals from regulators – throughout the world. Three recent examples of companies extending their reach across borders include: U.S.-based Abiomed garnering approval in India for three heart pumps; I. Ceram, a French company, achieving CE mark certification in Europe for […]

FDA actions to improve prescription drug labeling for pregnancy

When healthcare providers look to prescribe a medication, ideally their decision is clear cut because ample clinical data exist in the relevant study populations. In reality, however, it is not uncommon that certain patient populations are not yet well captured, if at all, in prescription drug labeling. This is the case for pregnant women, who […]