FDA approves SK Biopharma’s seizure drug

FDA has given Arvelle Therapeutics’ Xcopri the go-ahead for partial-onset seizures in adults. The emerging company, which is part of a subsidiary of SK Biopharmaceuticals, announced that it has also licensed exclusive rights to develop and commercialise the drug in Europe, with intent to file a Marketing Authorisation Application (MAA) in the first half of

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Regulatory Professionals attends TOPRA 2019 Symposium

Regulatory Professionals were delighted to exhibit again at the TOPRA symposium, the biggest event in the organisation’s history for a few years, drawing over 650 delegates and exhibitors.  With representation across industry from pharmaceutical, veterinary medicines and medical device sectors, plus patient groups, charities, healthcare professions, and more.  The presentations and sessions were hugely insightful

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FDA rejection AZ’s COPD treatment puts pressure on their competitive edge

FDA has issued a complete response letter for the New Drug Application (NDA) for PT010 (budesonide/glycopyrronium/formoterol fumarate); Paul Jeng, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers his perspective: “In an attempt to close the gap with chief chronic obstructive pulmonary disease (COPD) rival GlaxoSmithKline (GSK), AstraZeneca pushed to file an

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NICE recommends Takeda’s HAE treatment, Takhzyro for use on NHS

A final appraisal document has been published indicating the subcutaneous injection as an option for preventing recurrent attacks of hereditary angioedema (HAE) in patients aged 12 and older, meaning that those eligible can now receive the innovative treatment. Although patients will only receive the drug if they are eligible for preventive C1-esterase inhibitor (C1-INH) treatment

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