Regional Comparisons

In this third article of a series on new drug reimbursement recommendations by the HTA body NICE, the Pink Sheet finds that fewer innovative medicines are reimbursed in England than in eight other European nations.

Relyvrio/Albrioza, Amylyx’s ill-fated treatment for amyotrophic lateral sclerosis, was approved for marketing by the US Food and Drug Administration but rejected by the European Medicines Agency. The Pink Sheet explores how the two agencies applied the available regulatory flexibilities and the impact of other factors, such as regulatory precedence and patient influence, on decision-making.

Pink Sheet reporter and editors discuss the impact of a US and EU drug approvals analysis that found the US FDA still clears many novel products first, including most new cell and gene therapies and cancer treatments.

Comprehensive table comparing all the novel agents approved by either the US FDA or the European Commission over 2023 through April 2024.

Pink Sheet infographic shows how a large majority of novel drugs make it past the US FDA before receiving approval in the European Union. Lag times ranged from almost five years to less than two weeks.

Ninety-five percent of novel cancer treatments approved in both the US and Europe received the FDA’s OK first, but Europe usually followed within a year, a Pink Sheet analysis shows.

Only three of the 10 new therapies approved by the US FDA also have been approved in the European Union, while both of the EU gene therapy approvals followed FDA clearance, a Pink Sheet analysis shows.

A Pink Sheet analysis finds US approval preceded European Union clearance for 80% of products approved in both areas, but when EU approval came first, it beat the FDA by a median of 13 months. US-first approvals came close to six months before the EU.

Regulators from the US, Canada, European Union, Switzerland and Japan talk about the benefits of global collaboration, and reasons why they might reach different decisions on the same drug, at the American Society of Clinical Oncology annual meeting.

A study of diabetes rates across the US over four years reveals significant increases in the disease in many states. Tobias Oerum, diabetes advocate and cofounder of the company that conducted the study, discussed the data and some of the factors contributing to this troubling trend with Medtech Insight.

EMA charges participants to receive scientific advice through the fledgling program, unlike the US FDA, which may not fit the budgets of some complex generic sponsors. At the same time, sponsors also may simply not be aware the program exists yet.

Regulatory reliance was the theme on Day one of the 25th Management Committee of the International Medical Device Regulators Forum in DC, with regulators from across the globe touching on the need for clarity, consistency, and trust among the world’s various regulatory bodies. The attendance for this year’s meeting was largest in the history, with some 1,200 guests representing more than 60 countries and 550 public and private sector organizations.

Acknowledging that it may be a barrier to some extent, EMA’s senior scientific specialist of clinical pharmacology Kevin Blake notes that EU reference medicinal products are a legal requirement for bioequivalence studies and cannot be circumvented.

While EU preparations are underway to introduce strict legal requirements for all AI systems, the UK has doubled down on its flexible, non-regulatory framework. In this second of a two-part article, a lawyer explains the pros and cons of each for pharma and medtech firms.

Flexible thinking and rigorous standards will both be needed to develop psychedelics as drug therapies in order to surmount the many complicating factors, from unique ‘set and setting’ aspects to functional unblinding, speakers at Reagan-Udall Foundation meeting agree.

While approaching the third year of its launch, the parallel advice program has seen a handful of applicants, but regulators on both sides of the Atlantic remain optimistic.

International interest in fast-track regulatory reliance and collaboration pathways such as Project Orbis and the ACCESS Consortium has grown in recent years, a trend that looks set to continue in 2024. But some policy experts have warned that faster approvals are not always better, with one academic claiming the bar for marketing authorizations has dropped “far too low.”

Sixteen cancer therapies have been granted marketing authorizations or label variations in the US this year via the Project Orbis scheme. However, the majority of these are still under review by Orbis partners, which have also been outpaced by the non-Orbis EU.

In this episode, HBW Insight speaks to Simon-Kucher & Partners about the latest trends in preventative consumer health. Partner Christian Rebholz and senior director Lorenzo Eandi explain the findings from the company’s recently published Better Health Report, which reached out to almost 3,000 consumers across the world. We take a deeper dive into Brazil, where consumers are spending more on than average on preventative health, and Germany, where consumers are spending less but are turning to digital tools thanks to government support. We also find out what consumer health companies can do to respond to a growing awareness of mental health, especially among women and the younger generation.

European Union reform proposals could reduce ‘clock stop’ time in drug reviews, which a new study identified as the primary driver of longer review times at the EMA compared with the US FDA.