Market Access

Pharmaceutical cold chain products are growing in number, complexity and reach. While life sciences organizations and their partners have been steadily investing in capabilities to effectively manufacture and distribute them, scaling them at the speed of innovation in an era of increasing regulatory and environmental requirements is more and more challenging.

Agreement of deals that promise better value for money and enhanced patient access to new treatments has become routine in England, but are they delivering?

Health care companies making carbon neutrality claims must tread a careful line while ensuring full accountability. CMS Vienna partner Gabriela Staber points to some of the risks businesses should be aware of when making sustainability claims.

The Clinical Trials Regulation finally entered into application on 31 January 2022, replacing the largely national, and sometimes inconsistent, rules created by the Clinical Trials Directive. In this article, law firm Cooley advises on the changes introduced by the CTR and explores ways in which firms can reduce their contractual risks and potential legal liability.

There are fewer than a handful of approved prescription video game digital therapeutics, but gamification in patient care is proving its worth as a novel way of treating a range of conditions, from vision loss to dyslexia and ADHD. Now, the onus is on lawmakers and insurers to create a clear path towards reimbursement.

Both the US and EU are gradually warming up to medical marijuana, but clunky and inadequate regulation threatens to curtail the growth of a burgeoning industry.

From a scientific perspective, the outlook for patient with rare disease has never been brighter. This year, 13 new cell or gene therapies could be approved in the US, Europe or both by the end of 2023. However, the challenges that stop patients accessing new therapies remain. Could this year be the turning point when our health care systems start to catch up with our science?

Based on a new report by the Wharton School, this article tackles criticisms against the intermediaries that connect buyers and sellers, the GPO and PBM. It also analyzes the existential threats facing these intermediaries such as 'safe harbors', threats of disintermediation, and the consolidation of suppliers.

Can environmental sustainability become a business differentiator? Some companies are already onto it. Boston Consulting Group puts the case in favor of the argument.

The integration of smart connected care, broadening of diagnosis and therapy into new settings and improvement of chronic disease outcomes will continue to shape the market for devices and diagnostics companies for years to come. But there is also a maze of short-term macroeconomic issues for medtechs to work through.

Originally intended to increase medical device safety, the implementation of the EU’s medtech regulation was so hampered in 2022 that it had started to look as if the new regulations were a bigger potential threat to patients than any of the scandals leading to its more stringent requirements. With the European Commission’s latest plans to ease challenges around implementation, will 2023 be a more positive year for the EU medtech sector?

For 12 years, bluebird bio has been developing gene therapies for rare genetic disease and now, with two approvals under its belt, the company is continuing to explore uncharted territory as it brings forward innovative new treatments. Holding the map is CEO Andrew Obenshain.