Real-world data collected from a wide range of sources, such as wearable devices and public databases, can be used by pharmaceutical companies to boost their marketing authorization and health technology assessment applications, a regulatory policy expert from Sanofi says.
The European Commission has indicated a “strong intent” to take real-world evidence and “broader health care data” into greater consideration during regulatory and HTA decision-making in the future, according to Rebecca Lumsden, Sanofi’s head of regulatory science & policy, EU/AMEE regions.
During a presentation at the RAPS Euro Convergence meeting on 7 May, Lumsden outlined the potential for companies to use “heterogenous health data” in their dossiers,
Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.
The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.
The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.
The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.
Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.
Brazil’s drug pricing authorities are planning to introduce, among other things, a new drug category for biosimilars to ensure the pricing procedures for such medicines are reflected in the official pricing framework.
The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.
