Clinical Trials
While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.
Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.
The Clinical Trials Regulation was “supposed to harmonize” requirements in the EU, but instead it is giving some countries the chance to get ahead by offering faster approval timelines, notes Telethon’s head of regulatory affairs.
Companies have until 17 March to respond to an EU consultation on a new strategy that will seek to simplify the regulatory framework and make it easier for innovative small and medium-sized enterprises to “access the capital they need” to scale up in the bloc.
Experts argue that current guidelines on attributing responsibilities in clinical trials point in the right direction but lack the specificity to address the diffusion of responsibilities caused by the use of AI systems in decentralized studies.
Trial sponsors in Germany should start preparing negotiation strategies to tackle difficult discussions with trial sites over standardized clauses.
A new Innovative Health Initiative project will see the German health technology appraisal (HTA) body, IQWiG, work towards ensuring evidence generated in clinical studies meets the needs of HTA bodies and regulators.
ILiAD Biotechnologies explains why it is confident that it will secure approval for the first-ever pivotal Phase III study using a human challenge model for a whooping cough vaccine. Also, it outlines why the UK is the preferred destination for this ground-breaking study.
Sponsors who want to ensure their approved studies are visible to patients on the new EU clinical trials map must update their records in the Clinical Trials Information System on time and in accordance with the Clinical Trials Regulation.
The FDA Commissioner nominee also commented on trial diversity, the role of public comment and expedited biosimilar reviews during his Senate confirmation hearing.
During his Senate confirmation hearing, Bhattacharya also said he does not believe the MMR vaccine causes autism and emphasized transparency with NIH-funded researcher ties to the pharmaceutical industry.
Canada’s new guidance on rare disease registries is based on international guidelines, but in some areas there remains work to ensure that implementation of some recommendations is feasible in the Canadian context.
Two recent disclosures from Xbrane Biopharma and Formycon demonstrate the evolving US Food and Drug Administration thinking about the need for Phase III trials to support biosimilar filings.
A retrospective analysis does not support a claim that multiple myeloma patients are more adherent to Hemady than generic dexamethasone, OPDP said in an "untitled" letter suggesting increased enforcement focus on promotions leveraging the agency’s 2018 CFL guidance.
Companies that fail to provide patient health data for secondary use when requested under the new European Health Data Space could be fined and also prevented from making access requests from other entities, a European Commission representative says.
The European Medicines Agency has launched an interactive map to improve visibility on ongoing clinical trials in the EU, with the aim of stimulating greater patient participation and awareness.
As part of efforts to modernize its clinical trials framework, the Canadian regulator is looking to better facilitate expanded access clinical trials, which allow investigational drugs to reach patients with serious conditions before they are approved.
Pharma industry representative at the ICH expert working group that drew-up the new international good clinical practice standard is advising trial sponsors to focus on proportionality and a risk-based approach throughout their trial design, conduct, analysis and reporting.
In an ongoing effort to accelerate the commercialization of select innovative drugs and medical devices, Korea’s MFDS is launching a new program for certain products that will receive regular regulatory consultations until they reach the approval stage.
Clinical trial draft guidance webpages are back online following a court order, but with new language disclaiming any information promoting gender ideology as "extremely inaccurate."