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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European Commission expands approval of Alexion’s eculizumab

Alexion Pharmaceuticals’ eculizumab has been approved by the European Commission for the treatment of neuromyelitis optica spectrum disorder (NMOSD), extending its current marketing authorisation. NMOSD is a rare, devastating, complement-mediated disorder of the central nervous system characterised by relapses, also referred to as attacks. Previously known as Devic’s Disease, NMOSD is often confused with other

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Fast-track status completed for AbbVie and BI’s psoriasis treatment Risankizumab

NICE published a final recommendation for AbbVie and Boehringer Ingelheim’s Risankizumab today, completing fast-track process that sees the psoriasis treatment gain market access in record time. The drug is one of the first treatments to go through NICE’s fast-track appraisal system, which accelerates the review process, whilst also cutting the standard 90-day implementation period down

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NICE emphasises requirement for more cannabis related research

NICE has published its new draft recommendations on the use of cannabis-based medicinal products, following a comprehensive evaluation of their clinical and cost-effectiveness. The organisation says that the recommendation of fast-tracked guidance follows the re-classification of these products last year to allow specialist doctors to ‘prescribe them where the clinical needs of patients cannot be

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EMA gives positive opinion for Keytruda combination

EMA has decided on a positive opinion for a new combo of MSD’s cancer blockbuster, Keytruda (pembrolizumab) and Inlyta (axitinib). The organisation’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of the anti-PD-1 therapy and Inlyta combo, a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced

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