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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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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NICE presents long anticipated review of methodologies

NICE has unveiled a long-awaited review of its health technology evaluation methodologies, although a re-think on its core ‘QALY threshold’ approach won’t be included. England’s cost effectiveness watchdog recently celebrated its 20th anniversary and has often had a fractious relationship with the pharma industry over those years, especially when drugs have been rejected because of

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NICE Patisiran approval puts Alnylam back in hATTR running

NICE recommends use of Alnylam’s Patisiran, after issuing a preliminary ‘no’ back in December 2018. The treatment is for a progressive, life-threatening disease called hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis), which until recently, was an area of significant unmet need in England. The drug will now provide eligible patients suffering from the disease with a treatment

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Akcea obtains NICE approval for stage 1 or 2 polyneuropathy in adult patients with hATTR

Akcea Therapeutics’ Inotersen has received recommendation from NICE, meaning the therapy will now be made available to NHS patients in England and Wales for the treatment of Stage 1 or Stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).  hATTR is a serious condition caused by “the abnormal formation of the TTR protein

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FDA gives green light to ADHD medical device

NeuroSigma’s prescription-only Monarch external Trigeminal Nerve Stimulation (eTNS) System is the first non-drug treatment for ADHD to be approved by the FDA and is indicated for patients aged 7 to 12 who are not taking a prescription ADHD medication. The device, which is approximately the size of a mobile phone, generates a low-level electrical pulse

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FDA approves Pfizer’s breast cancer biosimilar

US Patients will now be able to access another biosimilar version of Trastuzumab with the FDA approval of Pfizer’s Trazimera in the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Data supplied with the application supported the similarity of Trazimera to its reference

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