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Could GSK myelofibrosis treatment gain EU-first approval?

European Pharmaceutical Review

The pharmaceutical company also highlighted that the decision was additionally supported by data from a subpopulation of adult patients with moderate to severe anaemia from the SIMPLIFY-1 Phase III trial. GSK shared that a decision on marketing authorisation for momelotinib in the EU is expected by early 2024.

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EU expands accessibility of product information for medicines with electronic format

Hospital Pharmacy Europe

It also allows pharmaceutical companies to monitor product information and keep it constantly updated, as well as offering healthcare professionals and patients greater accessibility. Pharmaceutical companies participating in the pilot create and submit the ePI via the PLM Portal as part of their regulatory application.

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Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

This can be achieved by reducing the burden of adverse reactions or by optimising benefits through patient selection (eg, contraindications, recommendations of use, warnings, concomitant medicine[s], or certain test parameters) and treatment management (eg, specific dosing regimen, relevant testing, patient follow-up).

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Boehringer sells drug safety software to ArisGlobal

pharmaphorum

The software can be used to conduct an initial analysis of adverse reactions to medications that have already been approved to identify potential side effects and undesirable events, and provides a decision-making tool for those working in pharmacovigilance, helping them process each case more quickly.

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When is the best time to inject Ozempic?

The Checkup by Singlecare

Ozempic is made by the pharmaceutical company Novo Nordisk. People with symptoms of an allergic reaction should get emergency medical help. Currently, Ozempic is FDA-approved for adults with Type 2 diabetes. Many people lose weight while taking Ozempic, and the medication is often prescribed off-label as a weight loss drug.

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FDA Approvals: September 2022 Recap

Digital Pharmacist

When it comes to innovation in the development of new drugs and therapeutic biological products in the pharmaceutical industry, the United States Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) is a key supporter of the pharmaceutical industry. . Date of Approval: 9/21/2022.

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Innovation in immuno-oncology: Leading companies in oncolytic viral proteins

Pharmaceutical Technology

A major strategy for OV development is genetic manipulation to weaken virus pathogenicity, enhance target selectivity, reduce adverse reactions, and/or insert exogenous therapeutic genes into the virus genome. OVs can be attenuated natural viruses or recombinant viruses.