Interviews
Retiring CDER Deputy Director Douglas Throckmorton spoke to the Pink Sheet ahead of his early 2025 retirement about regulatory flexibility, AI and other topics.
The Equitable Breakthroughs in Medicine Development initiative, funded with a PhRMA grant, provides sites in historically under-represented communities with support to conduct clinical research. In an interview, EQBMED’s Tesheia Johnson Harris talks about the local sites selected, therapeutic areas for research, and learnings to date.
EU legislators must be “mindful” that any changes made to the EU orphan medicines framework and its incentive structure will impact drugmakers and patients for the next two decades, says Soraya Bekkali, head of Europe, Canada, and international at Alexion.
The potential for manufacturer liability may become a concern if problems providing rebates to pharmacies on negotiated drugs emerge because the system goes awry, a former CMS official suggested in an interview with the Pink Sheet.
The European Commission’s proposed pharma legislation overhaul could expand the definition of a gene therapy medicinal product, posing challenges both from a regulatory and public perception perspective.
The European Parliament proposed introducing joint procurement for orphan medicinal products in the EU pharma legislation overhaul – a move that the new CEO of EURORDIS says could lead to “faster and more equitable” access to drugs for rare diseases.
The head of the Korea Regulatory Science Center talks exclusively to the Pink Sheet about why regulatory science is crucial, the country's efforts to improve in the area and the center's strategic bridging role.
Greater transparency around EU health technology assessment processes “can only be a good thing” for innovative rare disease therapies, Virginie Bros-Facer, the new CEO of the EU network of rare disease patient organizations, EURORDIS, tells the Pink Sheet.
When the agency decided biosimilarity standards would be high, it likely ensured the interchangeability designation eventually would become unnecessary.
CRO executive Horst Ruppach discusses the critical factors that drug manufacturers must consider to ensure compliance with the revised ICH Q5A(R2) guideline on biologics viral safety. Thorough documentation and proactive engagement with regulatory bodies are key to navigating the complexities of viral safety evaluation in biotechnology products, he says.
The rate of non-submissions for combination therapies in England has been on a downward trend in the last two years.
As Sandoz publishes a report on US drug shortages, including a call for policy and other improvements, the firm’s North America head and AAM Chair Keren Haruvi discussed potential solutions to ongoing supply-chain failures.
The ISRCTN clinical trials registry has launched an improved dashboard to provide metrics that reveal how many studies are complying with key transparency requirements. Badges are in place for individual studies meeting the transparency criteria.
High unmet needs is among the terms and definitions in the EU’s regulatory reform package that are “very subjective” and require more clarity to improve predictability for the pharmaceutical industry, EUCOPE’s secretary general, Alexander Natz, tells the Pink Sheet.
John Murphy, who will take over the Association for Accessible Medicines in October, said in an interview that the number and types of voices advocating for the generics industry must increase.
The EU HTA Regulation will see clinical comparisons of medical products conducted at an EU level. However, the needs of some smaller nations may not be represented, experts from Cencora explain in this second of two articles on the new EU joint clinical assessments.
Manufacturers should undertake scenario planning exercises and simulations to prepare for questions that will be asked under the upcoming EU HTA Regulation, but unpredictable questions are likely to arise, experts from Cencora caution in this first of two articles on the new EU joint clinical assessments.
Improvements in the UK’s manufacturing and clinical trial ecosystems are on the “Christmas list” of Ioana Parsons, Ipsen’s general manager for the UK & Ireland.
Regulators in Europe and the US have demonstrated a commitment to providing guidance that will make decentralized and point-of-care manufacturing a reality, the CSO of GermFree, a company that provides mobile and modular cleanrooms for manufacturing advanced therapies, tells the Pink Sheet.
AI modeling can predict which animal tests are useful and necessary, saving money for companies and meeting objectives set by regulators in the US and EU, VeriSIM Life’s CEO and founder Jo Varshney tells the Pink Sheet.