Interviews
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.
Before J&J’s former chief data scientist Najat Khan moved to Recursion, she talked to the Pink Sheet about how AI is transforming trials and driving collaboration between industry and regulators.
The payor’s multiyear plan to ditch the traditional PBM model and use multiple vendors has drawn a lot of skepticism from other actors in the health care system, but Blue Shield is hoping that it can help give policymakers some momentum, VP Lum tells the Pink Sheet.
As Hatch-Waxman celebrates its 40th anniversary, the chair of the US generic trade association talks about striking the right balance on supply and pricing, preventing shortages, and improving Medicare price negotiations.
In an interview, Sarah Emond talks about why she is ‘worried’ about cell and gene therapy, when ICER might revise its assessment of obesity drugs, and how CMS could build a reliable and transparent Medicare price negotiation program.
Artificial intelligence, real world evidence and point of care manufacturing are top priorities for the International Coalition of Medicines Regulatory Authorities, says the coalition’s chair, Emer Cooke.
Deputy director of the Bureau of Competition notes in an interview that the FTC focused on older products it felt should have more generic competition in its letters to companies citing improper patent listings. He says it is clear which drug-device combo patents should not be listed.
In a Pink Sheet interview Chief Scientist Bumpus discusses need to move diversity conversation up further in the pipeline. Better ‘organs on a chip’ should help.
The former US FDA commissioner turned venture CEO believes the biopharmaceutical industry can cure many of society’s ills, but firms need to talk to the agency more.