Interviews

From ACIP to Part D to data transparency, GSK has several policy asks as it prepares to launch its new RSV vaccine for older adults. The Pink Sheet spoke with GSK’s vaccine policy lead about the firm’s new data platform and the worrisome US vaccination trends following the Covid pandemic.

With global regulation of off-patent medicines continuing to evolve, IGBA secretary general Suzette Kox talks about the progress expected from regulatory harmonization for generics and a reduced clinical trial burden for biosimilars.

In a Pink Sheet interview Emil Kakkis contends the agency’s recruitment challenges, high turnover rates and a lack of expertise on the diseases for which reviewers are evaluating drugs have created a disconnect between FDA leadership’s stated willingness to permit accelerated approval for gene therapy and what review divisions are doing on the ground. 

With the first US Humira rival having just hit the market and biosimilars seeing increasing adoption overall, Craig Burton – executive director of the AAM’s Biosimilars Council – says that the US biosimilars market is ‘doing better, but we still have improvements to make.’

With a number of US complex generic opportunities in Teva’s pipeline, the company’s executive vice president for North America commercial, Sven Dethlefs, talks about the challenges of bringing complex products to market against a backdrop of evolving FDA requirements.

Sanofi executives discuss ongoing efforts to make the monoclonal antibody available for the next RSV season and the impact it will have as the first prophylactic treatment for all infants. An FDA advisory committee is expected to discuss the biologics license application at a yet-to-be announced meeting.

The new chair of the US generics association talks to the Pink Sheet about how to make sure that policymakers don’t take the industry for granted.

This second segment of a two-part Pink Sheet article on decentralized clinical trials looks at ensuring that staff at study sites are on onboard to support fast-paced change in this field, how regulatory guidance can help tackle hesitancy, and the need to transparently track such studies.

Novartis CEO Vasant Narasimhan, PhRMA's incoming board chair, says in an interview that the brand drug association has a slate of issues to pursue as it works to shape the implementation of the Medicare price negotiation program in the name of preserving innovation.

Research targeting botanicals generally, as well as cannabis, as potential APIs is increasing, a factor in CDER’s publication of cannabis trials guidance, the FDA’s Norman Birenbaum says in an interview.

The remarkable shift towards decentralized clinical trials in the last three years is a testament to how this patient-centric approach of doing research has the potential to solve multiple issues such as time, cost and low participation rates. In this first segment of a two-part article, the Pink Sheet looks at how innovation in this sector has just begun and we can expect more action ahead. 

Ivan Cheung, Eisai’s US CEO, explains the ‘question-by-question’ the company is taking to convince the Centers for Medicare and Medicaid Services that its Phase III Clarity AD results in Alzheimer’s offer the ‘high level of evidence’ needed for smooth reimbursement of lecanemab.