European Pharmaceutical Review

MARCH 7, 2025

A paper published by the Drug Safety Research Unit (DSRU) in the British Journal for Clinical Pharmacology , has asserted the need for ongoing assessment of the safety and effectiveness of the Alzheimers drug lecanemab in the real-world clinical setting.

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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.

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Safety Food and Drug Administration Prospecting Food 98

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.

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Medicine Manufacturing Safety Consulting 89

European Pharmaceutical Review

NOVEMBER 10, 2022

A new wave of medicines has emerged in recent years to supplement the well-established small and large molecule platforms that have historically dominated the market. Complex medicines offer diverse therapeutic modalities, including RNA therapeutics and antibody-drug conjugates (ADCs). What constitutes a complex medicine?

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Medicine Distribution Engineering Electronics 105

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.

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European Pharmaceutical Review

JANUARY 7, 2025

The guidelines address the safety, effectiveness or quality of these medicines. The US Food and Drug Administration (FDA) has for the first time, issued draft guidance on using artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product.

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Food and Drug Administration FDA Medical Food 105

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.

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European Pharmaceutical Review

JANUARY 31, 2023

Dupixent ® is indicated for EoE patients 12 years and older, weighing at least 40kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy. The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications.

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Medicine Safety Patients Pharmaceutical 98

Pharmaceutical Technology

MARCH 26, 2025

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has introduced new monthly safety bulletins aimed at making medical device and medicine safety information clearer and more accessible for healthcare professionals.

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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.

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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?

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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.

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Medicine Marketing Pharma Manufacturing 98

European Pharmaceutical Review

FEBRUARY 5, 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) is seeking feedback on its regulatory guidance for individualised mRNA cancer immunotherapies. This guidance aims to streamline access pathways for patients, without compromising on the safety of these personalised immunotherapies.

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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.

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Safety Medicine 105

European Pharmaceutical Review

FEBRUARY 4, 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for SARCLISA (isatuximab), making it the first and only anti-CD38 quadruplet therapy available for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

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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. .

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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).

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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.

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MedCity News

JANUARY 30, 2024

One example of how AI is already being used to personalize cancer treatment is in the field of precision medicine. Precision medicine involves tailoring treatments to a patient’s unique genetic makeup, disease profile and lifestyle. However, conducting clinical trials can be time-consuming, expensive, and resource-intensive.

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Side effects Ethics Medical Patients 325

PharmExec

DECEMBER 6, 2023

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

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Safety Medicine 105

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.”

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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.

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Pharma Marketing Network

NOVEMBER 23, 2024

From AI-powered insights to the rise of precision medicine, new trends are reshaping the way we connect with patients and healthcare providers. Precision Medicine: Targeting the Right Audience Precision medicine, with its focus on individualized treatment, offers a goldmine of opportunities for marketers.

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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.

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Manufacturing Food and Drug Administration Engineering Safety 145

Contrarian Sales Techniques

NOVEMBER 18, 2024

Have you ever gone to a pharmacy with a prescription, only to find out the medicine isn’t in stock? When a pharmacist recommends an alternative, they’re using their expertise to find a medicine that works the same way as the one you were prescribed. It’s a bit of a letdown, right? Let’s talk about how they do it and why it matters.

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European Pharmaceutical Review

NOVEMBER 28, 2024

This dual-layer certification process can create significant delays, as each framework involves extensive assessments for safety and performance under separate requirements specific to medical device and AI-specific criteria. If successful in other jurisdictions, such product will eventually make their way to Europe for approval.

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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?

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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.

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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.

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Infuse Medical

FEBRUARY 4, 2025

Inadequate training can result in increased procedural errors, slower adoption of new technologies, and compromised patient safety. This hands-on, risk-free environment is particularly beneficial in high-pressure fields like surgery and emergency medicine.

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Training Medical Healthcare Healthcare 130

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.

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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.

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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.

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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.

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Food and Drug Administration FDA Safety Medicine 98

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 Marketing 109

European Pharmaceutical Review

NOVEMBER 7, 2022

The designation is based on six months of follow-up data from a Phase II study ( NCT04649359 ) evaluating the safety and efficacy of a 76mg weekly (QW) dose of elranatamab, which showed overall response rate (ORR) was 61 percent. . The investigation noted elranatamab delivered a manageable safety profile. percent) or Grade 2 (14.2

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Food and Drug Administration Medicine Safety FDA 105

European Pharmaceutical Review

FEBRUARY 21, 2025

Only one eye was treated to mitigate any potential safety issues. The therapy, known as rAAV8.hRKp.AIPL1, hRKp.AIPL1, is designed to enable the retinal cells to work better and to survive longer, by replacing the defective gene with healthy copies, according to the researchers.

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