Italy

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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

OTC sales edged up at Italy's Recordati in the first half of 2024 as higher demand for GI products and supplements offset a weaker cold & flu season.

OTC sales edged up at Italy's Recordati in the first half of 2024 as higher demand for GI products and supplements offset a weaker cold & flu season.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Casgevy, the world’s first CRISPR gene editing therapy, is the second drug to be accepted onto a managed access scheme via England’s Innovative Medicines Fund, offering a new treatment for patients with transfusion-dependent beta thalassemia.

Scotland’s health technology assessment body has agreed to reimburse Chiesi’s Elfabrio for Fabry disease, mirroring the decision from several other European countries – however, France turned down the rare disease drug, while Germany questioned its benefit.

Cooper Consumer Health has closed its acquisition of Viatris' OTC business as it commits to divesting the rights to infant laxative medicine Bebegel and earwax removal product Otowaxol in certain markets.

Did Samsung Bioepis and Biogen choose early US access for their Lucentis biosimilar in exchange for postponing launch in other markets? That’s what Italy’s competition authority believes, as it investigates the biosimilar sponsors and originator companies Genentech and Novartis.

J&J says it has “exhausted all current viable avenues” to get its antidepressant nasal spray Spravato reimbursed on England’s National Health Service, after NICE decided against re-appraising the drug following numerous funding rejections.

Did Samsung Bioepis and Biogen choose early US access for its Lucentis biosimilar in exchange for postponing launch in other global markets? That’s what Italy’s competition authority believes, as it kicked off an investigation into both the biosimilar sponsors and originators Genentech and Novartis.

Recent consumer health appointments in Europe and Asia: Italian and Spanish OTC associations elect presidents and vice-presidents; P&G India names Hygiene & Heath Care CFO.

Headwinds for the Russian ruble and Turkish lira held back growth at Recordati's OTC business in the first quarter of 2024.

Adult immunization programs can save “billions” for society, but their value is underestimated because of challenges around measuring broader value evidence and a lack of incentives for companies to collect this data, says the Office of Health Economics.

EU announces the third designation under the MDR in a month.  

Italy's Recordati saw its OTC sales grow by 10% in 2023 driven by the recovery of the cough & cold market and a growing demand for probiotics.

EuroAPI is on the backfoot once again after being forced to suspend production at its manufacturing site in Brindisi, Italy, weeks after unveiling a four-year strategic roadmap that sought to tighten and focus its operations amid a challenging two years.

Sweden's Karo has struck its second deal in six months bringing in the Proctosedyl hemorrhoid brand from Bayer.

As a number of major brands face generic and biosimilar competition, the loss-of-exclusivity impact across the leading 10 developed markets will approach $200bn over the next five years, according to a fresh medicines spending report running to 2028.

21 Invest has taken a majority stake it Italian food supplements player Omega Pharma Srl.