European Pharmaceutical Review
JANUARY 25, 2024
Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. 3 Moreover, digital platforms can be tailored to the needs of patients and healthcare professionals, offering accessible, trustworthy and up-to-date information on medicines precisely when required.
European Pharmaceutical Review
DECEMBER 14, 2023
Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve. Meta-analyses contributed least frequently (31.4
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European Pharmaceutical Review
DECEMBER 12, 2023
IPH5201 is being investigated in a Phase II trial, MATISSE, in combination with durvalumab (anti-PD-L1) and chemotherapy, in patients with resectable early-stage NSCLC. A favorable safety profile was also observed. Innate Pharma also developing IPH5201 in collaboration with AstraZeneca. An ORR of 46.4 percent in the blood.
European Pharmaceutical Review
DECEMBER 19, 2022
3 Under this pathway, comparability studies are required to substantiate the similar nature, in terms of safety and efficacy, of the biosimilar and the reference product. For this reason, a unique ‘abridged’ procedure was introduced to provide a specific regulatory pathway for biosimilars in the EU.
Legacy MEDSearch
OCTOBER 9, 2023
Data pooled from both the US and European/UK trials were used to assess the clinical safety and efficacy of histotripsy in destroying targeted primary and secondary liver tumors. with each event being common to focal liver therapies and not specific to histotripsy.
Pharmaceutical Technology
FEBRUARY 24, 2023
The overhaul will address drug marketing exclusivity length, pricing, patient access, innovation incentives, antimicrobial resistance, clinical trials, supply chain security and shortages, and environmental impact. The EU is planning a sweeping revision of its pharma legislation in March, the largest change in 20 years.
European Pharmaceutical Review
NOVEMBER 11, 2022
AHF is a major contributor to morbidity and mortality for heart failure patients. Patients admitted for acute heart failure are at high risk of readmission and death, especially in the first months after discharge. The trial evaluated the safety, tolerability and efficacy of NTLA-2001 in 12 participants.
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