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Teva subsidiary Ratiopharm has secured EMA backing for the EU-wide switch of allergy drug desloratadine.
From 20 October, a free online platform will allow registrants attending the digital Global Generics & Biosimilars Awards 2020 to participate in two weeks of dedicated networking activities ahead of the ceremony on 3 November.
Mylan is taking aim at a lucrative oral solid formulation in Europe, with the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending approval for the company’s generic version of Revlimid (lenalidomide) capsules.
Glenmark and Sun Pharma introduce nintedanib generics in India at a fraction of the innovator product’s price, vying for a share of the IPF market where pirfenidone currently holds sway.
Australia’s Therapeutic Goods Administration has set out proposals for a change to early-notification requirements for generic and biosimilar sponsors.
The AAM has published a position paper on nitrosamines that urges the FDA to revisit and reassess its safety limits for nitrosamines in pharmaceuticals, while also proposing a “science-driven” risk-based approach to evaluate drugs for the potential presence of nitrosamines.
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