European Pharmaceutical Review

JANUARY 15, 2024

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Agamree ® (vamorolone), as a safer alternative to corticosteroids, for Duchenne muscular dystrophy (DMD). “In The medicine is indicated in patients who are four years of age and over, independent of the underlying mutation and ambulatory status.

Medicine 105

Medicine Safety Patients Pharmaceutical 105

European Pharmaceutical Review

FEBRUARY 21, 2023

The UK medicinal cannabis sector has witnessed important regulatory advances in recent years. In this Q&A, EPR caught up with CEO James Short and Managing Director Arthur Wakeley from Celadon, to learn more about the company’s experience moving through, and progressing, the strict regulatory process for medicinal cannabis.

Medicine 132

Medicine Manufacturing Specialization Pharmaceutical 132

European Pharmaceutical Review

MAY 17, 2024

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European Union. The post EMA recommends suspension of hydroxyprogesterone caproate medicines appeared first on European Pharmaceutical Review.

Medicine 97

Medicine Safety Marketing Medical 97

European Pharmaceutical Review

JULY 12, 2023

Integrated safety analysis from five prospective clinical trials for the first and only single-dose, US Food and Drug Administration (FDA)-approved microbiome -based treatment to prevent recurrent Clostridioides difficile ( C. The analysis is the largest safety evaluation to date of any microbiota-based live biotherapeutic.

Safety 98

Safety Food and Drug Administration Prospecting Food 98

European Pharmaceutical Review

AUGUST 30, 2023

The Windsor Framework, announced on 9 June 2023 by the Medicines and Healthcare products Regulatory Agency (MHRA), provides a long-term solution for the supply of medicines into Northern Ireland. The agreement stipulates that certain conditions must be met in the labelling and packaging of these medicinal products.

Medicine 105

Medicine Marketing Government Safety 105

European Pharmaceutical Review

OCTOBER 22, 2024

The UK is set to be the first country to introduce a new regulatory framework for innovative products manufactured at or close to the point of patient care, says the Medicines and Healthcare products Regulatory Agency (MHRA). The agency anticipated that the regulation could become law in Summer 2025.

Medicine 89

Medicine Manufacturing Safety Consulting 89

European Pharmaceutical Review

JANUARY 25, 2023

The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for exagamglogene autotemcel (exa-cel), the first regulatory submission for a CRISPR-based medicine. The MAA from Vertex Pharmaceuticals and CRISPR Therapeutics is supported by two global Phase III studies.

Medicine 111

Medicine Food and Drug Administration FDA Pharmaceutical 111

European Pharmaceutical Review

JANUARY 26, 2024

First medicine approved in EU for eosinophilic esophagitis What did the data from the Phase III Dupixent study show? The post Eosinophilic esophagitis medicine approval expanded appeared first on European Pharmaceutical Review.

Medicine 98

Medicine Food and Drug Administration FDA Pharmaceutical 98

European Pharmaceutical Review

JULY 27, 2023

This decision by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP). The medicine works by inhibiting the C5 protein in the terminal complement cascade within the body. Soliris is administered intravenously every two weeks.

Medicine 98

Medicine Safety Patients Pharmaceutical 98

European Pharmaceutical Review

MARCH 27, 2024

The authors highlighted the variations in methods advised in guidelines from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) were a contributing factor. However, due to the importance of pyrogen testing for the safety of pharmaceutical products , the report stated that this will help to drive market growth.

Safety 94

Safety Marketing Food and Drug Administration Pharmaceutical 94

European Pharmaceutical Review

DECEMBER 22, 2022

Advances in mRNA technologies and cellular delivery systems coupled with their cost effectiveness, manufacturing simplicity and ability to target previously-undruggable pathways has limitless potential that could revolutionise medicine. 2022) The Progress and Promise of RNA Medicine – An Arsenal of Targeted Treatments. References.

Medicine 116

Medicine Food and Drug Administration Transportation Distribution 116

European Pharmaceutical Review

JULY 3, 2023

It has a good safety profile and was well- tolerated, and could provide an important new therapeutic option for long-term treatment of patients with this debilitating condition,” stated Howard Mayer, Executive Vice President and Head of Research and Development for Ipsen. The post Could small molecule medicine treat rare liver disease?

Medicine 98

Medicine Food and Drug Administration Food Patients 98

PM360

JUNE 26, 2023

Access to medicines have persisting and systemic differences across the globe and within countries. It is estimated that nearly two billion people globally do not have access to essential medicines. Traditionally, pharmaceutical companies have not prioritized emerging markets as part of their access strategy.

Medicine 98

Medicine Marketing Pharma Manufacturing 98

Pharmaceutical Technology

OCTOBER 7, 2024

The safety review was requested by the French medicines agency, citing new safety reports that alter the risk profile of finasteride.

Safety 105

Safety Medicine 105

European Pharmaceutical Review

NOVEMBER 17, 2023

UBRELVY was well-tolerated with no new safety signals observed when administered during the prodrome, data from the clinical trial found. ” The post Trial for novel CGRP migraine medicine gleans positive results appeared first on European Pharmaceutical Review. .

Medicine 96

Medicine Safety Patients Pharmaceutical 96

Pharmaceutical Technology

JUNE 20, 2023

It was developed in collaboration with the Institute for Protein Design (IPD) at the University of Washington School of Medicine, with funding support from the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI).

Safety 145

Safety Medicine Healthcare Healthcare 145

European Pharmaceutical Review

FEBRUARY 27, 2024

The Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), Dame June Raine, will step down in the Autumn following five years in the role. While she is stepping down from her current role, Dame June shared that she still hopes to contribute “to patient safety and public health in other ways.”

Safety 111

Safety Pharmacology Medicine Management 111

World of DTC Marketing

JUNE 3, 2022

. “The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. It is essential that the ground rules for these AI tools include firm parameters that seek to prioritize patient safety.

Doctors 291

Doctors Insurance Medical Patients 291

PharmExec

DECEMBER 6, 2023

National Library of Medicine study emphasizes inadequacies in ensuring the safety and efficacy of over-the-counter dietary supplements.

Safety 105

Safety Medicine 105

World of DTC Marketing

JULY 13, 2021

A study published in JAMA Internal Medicine found that among cancer drugs that received accelerated approval from the FDA using surrogate endpoints or other measures, only one-fifth ended up improving overall survival rates in later confirmatory trials. Can we make sense of this? Maybe they should. That says enough.

FDA 187

FDA Medicine Healthcare Healthcare 187

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. They are vital to ensuring the safe and effective use of medicines, making them an integral part of healthcare in Europe. percent as EU average with some Member States as high as 25 percent).

Healthcare 98

Healthcare Healthcare Safety Electronics 98

European Pharmaceutical Review

JULY 5, 2024

I welcome the new Labour government and urge them to start conversations with EU representatives to ensure that we collaborate with our colleagues in the EU in developing drug safety guidelines and regulations and making pharmacovigilance decisions that protect the public.

Pharma 98

Pharma Government Safety Medicine 98

European Pharmaceutical Review

JUNE 13, 2024

Shortly thereafter, the European Medicines Agency (EMA) reviewed the study design, endpoints, and planned statistical analysis, and deemed the US-based trial acceptable for a Marketing Authorisation Application (MAA). In December 2023, the FDA granted OCU400 Regenerative Medicine Advanced Therapy (RMAT) designation.

Manufacturing 145

Manufacturing Food and Drug Administration Engineering Safety 145

World of DTC Marketing

MARCH 23, 2022

Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. The program was codified into law under the Food and Drug Safety and Innovation Act (FDASIA) in 2012. Do patients care?

Patients 200

Patients FDA Doctors Physicians 200

European Pharmaceutical Review

JUNE 28, 2024

HUADONG MEDICINE, via its subsidiary Hangzhou Zhongmei HuaDong Pharmaceutical CO. According to the trial data, the dose range of 10mg to 600mg for HDM1002 offered good safety and tolerability. Twenty-eight days of continuous dosing within the dose range of 50-400mg revealed that HDM1002 had “good” safety and tolerability.

Safety 105

Safety Medicine Pharmaceutical Patients 105

European Pharmaceutical Review

MAY 2, 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a policy paper on its strategic approach to artificial intelligence (AI). It summarises the MHRA’s view on the UK government’s white paper on AI regulation published in 2023.

Safety 115

Safety Medicine Government Medical 115

European Pharmaceutical Review

JULY 4, 2024

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. 6 Thus, it is critical to ensure the consistency of therapeutic effect across batches (see box).

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103

European Pharmaceutical Review

JANUARY 30, 2024

The European Medicine Agency’s human medicines committee (CHMP) recommended marketing authorisations for the regulatory approval of three medicines at its January 2024 meeting last week. Additionally, a positive opinion for Niapelf (paliperidone), a generic medicine for schizophrenia was adopted in the meeting.

Medicine 98

Medicine Marketing Safety Pharmaceutical 98

European Pharmaceutical Review

JANUARY 18, 2023

Celadon Pharmaceuticals’ Midlands site is now registered by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for GMP manufacturing. The firm’s medicinal cannabis product will be supplied in oil form as an API. Navigating the cannabis API market. A new GMP registration is positive news for the sector.

Manufacturing 119

Manufacturing Medical Medicine Pharmaceutical 119

Pharmaceutical Technology

MAY 30, 2023

SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. The vaccine was also found to have a standard safety and reactogenicity profile when administered as a primary two-dose vaccination.

Medicine 119

Medicine Distribution Marketing Safety 119

European Pharmaceutical Review

SEPTEMBER 22, 2022

EBT-101, a CRISPR-Cas9 gene editing system delivered by adenovirus-associated virus vector serotype 9 (AAV9) has been administered to the first individual in a Phase I/II trial designed to establish its safety and efficacy. Biodistribution, pharmacodynamic, and efficacy assessments will also be conducted.

Patients 145

Patients Safety Medicine Physicians 145

European Pharmaceutical Review

NOVEMBER 13, 2023

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for GSK’s momelotinib, recommending marketing approval. It would be sold under the proposed trade name Omjjara.

Medicine 109

Medicine Safety Pharmaceutical Patients 109

Pharmaceutical Technology

MAY 4, 2023

It is based on data from a cohort in a Phase III, 24-week, open-label trial assessing the safety, pharmacokinetics and pharmacodynamics of ivacaftor in CF patients with an ivacaftor-responsive CFTR mutation who are under 24 months old. This cohort showed a safety profile identical to that found in older children and adults.

Food and Drug Administration 98

Food and Drug Administration FDA Safety Medicine 98

European Pharmaceutical Review

NOVEMBER 16, 2023

It has been conditionally authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) as a gene-editing therapy for certain patients 12 years old and over with sickle-cell disease and transfusion-dependent β-thalassemia. No significant safety concerns were identified during the trials.

Safety 114

Safety Side effects Patients Medicine 114

European Pharmaceutical Review

JANUARY 27, 2023

The UK will be the first country to introduce a tailored framework for the regulation of innovative medicines manufactured at the point where a patient receives care, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.

Manufacturing 105

Manufacturing Medicine Consulting Engineering 105

European Pharmaceutical Review

MARCH 6, 2024

The US Food and Drug Administration (FDA) has approved the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. The FDA noted that its decision for the biosimilars is based on clinical study data, which showed no clinically meaningful differences from the reference medicines.

Food and Drug Administration 98

Food and Drug Administration Medicine FDA Food 98

Contrarian Sales Techniques

NOVEMBER 18, 2024

Have you noticed how government clinics can charge so little for medicines, or even give them away for free at times? Government clinics get their medicines directly from suppliers, often in bulk, at negotiated prices. Government clinics in Malaysia can offer medicines at minimal or no cost due to substantial government subsidies.

Government 52

Government Medicine Insurance Healthcare 52