FDA approves Merck/MSD’s antibiotic drug for bacterial pneumonia

Merck/MSD has won an approval from the FDA for its Gram-negative antibiotic Recarbrio, as a treatment for hospital-acquired and ventilator-associated bacterial pneumonia. Recarbrio is a combination treatment comprised of imipenem, a carbapenem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor. Imipenem works to kill the bacteria associated with the infection while the other

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EC approves Jazz Pharmaceutical’s narcolepsy and sleep apnoea treatment

Jazz Pharmaceuticals has received a European Marketing Authorisation for solriamfetoli as a treatment for excessive daytime sleepiness in adults with narcolepsy and obstructive sleep apnoea. The company announced that The European Commission (EC) has accepted the drug to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy as well as obstructive sleep apnoea (OSA),

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Minds are like parachutes; they work best when open – Read our latest Regulatory Affairs Report

The latest CPIA report features analysis and data from the Regulatory Affairs sector within the pharmaceutical industry for UK, Ireland, Germany, Switzerland, Belgium, Netherlands, and Luxembourg. Clinical Professionals Group CEO, Yvette Cleland comments: To view the full report and previous editions, please visit the CPIA report on the Clinical Professionals website here.  If you would

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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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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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