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.

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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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PharmaTech

JANUARY 17, 2024

The agency is reviewing data on secondary malignancies related to T-cells for approved CAR T-cell medicines.

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PharmaTech

MAY 17, 2023

The agency’s safety committee is reviewing hydroxyprogesterone medicines and issuing a reminder on safety issues regarding fluoroquinolone antibiotics.

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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.

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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.

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European Pharmaceutical Review

NOVEMBER 14, 2022

Four medicines recommended for approval in the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP)’s latest meeting included a biosimilar for osteoporosis and a novel COVID-19 vaccine. Indication extension recommendations for 11 medicines. CHMP’s safety update.

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PharmaTech

JANUARY 15, 2024

The European Medicines Agency safety committee says there is a potential risk of neurodevelopment disorders in children born to men treated with valproate.

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European Pharmaceutical Review

JULY 20, 2022

Withdrawing drugs over safety concerns requires careful analysis of the health benefits and risks by regulators. Monitoring and studying the side effects of licensed medicines is an essential part of drug development to ensure public safety. Six products were withdrawn or revoked for safety reasons during the study period.

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Medicine Safety Side effects Electronics 97

Fierce Pharma

JANUARY 25, 2024

But questions remained unanswered.

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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.

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pharmaphorum

JULY 6, 2022

And how can regulators balance timely access with robust safety? The FDA’s Breakthrough Designation and the EMA’s Priority Medicines and PRIME initiatives, for example, allow approvals to made on the basis of less comprehensive clinical data on the proviso that confirmatory data are submitted when they become available.

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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

European Pharmaceutical Review

DECEMBER 15, 2022

The European Commission (EC) has expanded the marketing authorisation for Dupixent ® (dupilumab) in the European Union (EU), to treat adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy, making it the first and only targeted medicine for the condition in Europe and the US.

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Medicine Safety Side effects Patients 98

Pharmacy Times

SEPTEMBER 4, 2024

OBX-115 could offer further treatment options for individuals with advanced or metastatic melanoma by enhancing persistence, antitumor activity, and clinical safety of TIL cell therapy.

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Pharmaceutical Technology

OCTOBER 25, 2023

A blockchain system intended to ensure the safety and authenticity of medicines across the supply chain could change the way that medical professionals work, as discussed at the 11th Annual Clinical Trial Supply Nordics conference.

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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

European Pharmaceutical Review

SEPTEMBER 21, 2022

Biosimilar medicine Ximluci (ranibizumab) for the treatment of neovascular age-related macular degeneration, a progressive retinal macular disease, causing gradual vision impairment, mainly in the elderly population. 11 medicines for indication extension. Safety update.

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Medicine Marketing Patients Safety 98

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

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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European Pharmaceutical Review

AUGUST 23, 2022

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. Some, 250,000 child deaths per year can be attributed to counterfeit malaria and pneumonia medicines.

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Pharmaceutical Technology

NOVEMBER 1, 2022

Intrinsic Medicine has signed a definitive business combination agreement with special purpose acquisition (SPAC) firm Phoenix Biotech Acquisition to create a public company. To be named Intrinsic Medicine following closing, the combined company will be led by current Intrinsic CEO Alexander Martinez and president and COO Jason Ferrone.

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Pharmaceutical Technology

APRIL 11, 2023

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies.

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Safety Food and Drug Administration FDA Side effects 59

European Pharmaceutical Review

JUNE 29, 2022

How does that impact the safety of the biologics? Safety is key to the development of any medicine, but the safety considerations linked to bioproduction are more complex because biologics are more sophisticated medicines than small molecules. London: European Medicines Agency; 2016 [cited May 2022].

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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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PharmaTech

DECEMBER 22, 2022

Additionally, 89 human medicines have been recommended for approval by the EMA, and the organization also analyzed a new vaccine against dengue and two diabetes treatments that address important public health issues outside the EU.

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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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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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Pharmaceutical Technology

JULY 7, 2022

But scientists have struggled to find effective treatments for many of these diseases since the dawn of modern medicine. It is certainly a pivotal moment for the cell and gene industry, with the next decade of R&D and clinical trials expected to transform the future of medicine.

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Pharma Marketing Network

MAY 3, 2023

In this article, we will explore the regulatory environment of pharmaceutical marketing and how companies are navigating it to balance patient safety and industry innovation. In conclusion, navigating the regulatory environment of pharmaceutical marketing requires a delicate balance between patient safety and industry innovation.

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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).

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PharmExec

APRIL 25, 2024

Companies reported that the new formulation of Coartem met required pharmacokinetic profiles and displayed promising efficacy and safety treating malaria in infants.

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Pharmacy Times

NOVEMBER 6, 2023

The need for additional data on safety and efficacy of medicines both new and old that assess all potential risk factors is ever present, with health system pharmacists at the front lines.

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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).

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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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European Pharmaceutical Review

AUGUST 23, 2024

EU GMP Annex 1 is the European Union’s guidelines for good manufacturing practice (GMP) of sterile medicinal products for human and veterinary use.1 EU GMP Annex 1 is the European Union’s guidelines for good manufacturing practice (GMP) of sterile medicinal products for human and veterinary use.1

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Pharmaceutical Commerce

MARCH 29, 2023

Why automation-enabling tech—such as NLP and ML—can help improve medicine effectiveness.

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