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Teva asks SCOTUS to overturn “skinny label” verdict on GSK drug

pharmaphorum

The case hinges around the concept of “ skinny labelling ” which was introduced to stop drugmakers extending the exclusivity period for their branded medicines – through a stream of new indications or patient populations – that can be protected with so-called “use” patents. The substance patent expired in 2007.

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FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis

pharmaphorum

The approval comes a few weeks after the biosimilar was cleared for marketing in the EU with a broader label, as it also includes diabetic macular oedema (DMO), another of Lucentis’ approved indications. Sales reached a peak in 2019, when Roche booked $1.8 billion in sales from the drug while Novartis made $2.1 billion and $1.9

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Drugs and Lactation

RX Note

Website: [link] Summary In a 2007 study comparing safety in lactation information provided by 10 different references for 14 commonly used medications, significant variation was found between resources, even for medications well established as safe for breastfeeding.

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Pressure rises on Lucentis, as Coherus biosimilar gets FDA nod

pharmaphorum

Byooviz launched on 1 July at a 40% discount to Lucentis, with a label that covers use of the biosimilar for wet age-related macular degeneration (AMD), macular oedema following retinal vein occlusion (RVO), and myopic choroidal neovascularisation. Roche has US marketing rights to the drug, and booked $1.3

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UK approves prescription-only melatonin drug for childhood ADHD

Pharmaceutical Technology

In July 2019, the MHRA held up Colonis for sending a letter to physicians advertising the off-label use of the drug in children and those with renal impairment. On 22 September, the MHRA expanded the label to include the use for sleep-onset insomnia in children with ADHD. Melatonin is used globally as a supplement to improve sleep.

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EU pharmaceutical legislation revisions: what are the implications for biopharma?

European Pharmaceutical Review

Figure 1: Changes in the European Commission’s proposal for pharmaceutical legislation fall under seven key themes, based on L.E.K. analysis (Source: L.E.K) In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents.

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Drug Storage

RX Note

Introduction Once, I received a query from a ward nurse: If a product label mentioned that "Do not store over 25°C", is it fine for us to keep the medication in fridge? What does a cool place on the product label mean? Read the label to know the recommended storage temperature range.