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.

Healthcare 98

Healthcare Healthcare Safety Electronics 98

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.

Safety 118

Safety Patients Medical Transportation 118

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

Medicine 116

Medicine Safety Competition Networking 116

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.

Pharma 124

Pharma Engineering Safety Patients 124

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.

Medicine 52

Medicine Biopharma Safety Food 52

European Pharmaceutical Review

JULY 20, 2023

Background on BCT legislation in the EU Every year EU patients are treated with 25 million blood transfusions, a million cycles of medically assisted reproduction, over 35,000 transplants of stem cells and hundreds of thousands of replacement tissues.

Safety 75

Safety Distribution Food Medical 75

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.

FDA 52

FDA Food and Drug Administration Physicians Safety 52