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What’s Next? Five Things To Look Out For In June
Generics Bulletin previews the most notable and anticipated events for June 2023.
Coherus Looks To Galvanize Pegfilgrastim Biosimilar With New Formats
Coherus BioSciences spoke at length about its two marketed biosimilars, referencing Neulasta and Lucentis, during the company’s first-quarter earnings call.
Teva Prepares To Launch LAI Risperidone After US Approval
Teva has indicated an imminent launch after gaining a long-awaited FDA approval for the Uzedy long-acting injectable risperidone 505(b)(2) hybrid product on which the firm has partnered with MedinCell. Pricing information has also been revealed.
What’s Next? Five Things To Look Out For In May
Generics Bulletin previews the most notable and anticipated events for May 2023.
EU Reforms Offer Mixed Blessings For Generics And Biosimilars
A long-awaited package of European pharmaceutical legislation reforms unveiled by the European Commission contains a number of measures relating to generics and biosimilars – including changes to regulatory data protection periods, simplified marketing authorization procedures and moves towards greater digitalization.
Hyloris Submits Additional Data For Maxigesic IV Filing To US FDA
Hyloris has submitted additional data to the US Food and Drug Administration about its value-added analgesic Maxigesic IV, following enquiries about potential extractable and leachable compounds expected to be present in the product due to the packaging.
Accord Sees Benefits From Unique Portfolio
With Accord boasting a broad portfolio that encompasses generics, biosimilars, hybrid medicines and specialty products, Paul Tredwell – the firm’s executive vice-president for the Europe, Middle East and North Africa region – explains how this gives the company a unique position in the market.
Hyloris Lines Up Hectic Year Of Clinical Trials And Major US Launch
Hyloris has an eventful year ahead as it plans to conduct numerous trials for products in its ever-expanding pipeline and launch Maxigesic IV in the US.
Fresh Competition Coming For Narcan In US
Further US hybrid and generic rivals to Narcan are in the works, with Amphastar having just received an FDA nod for its naloxone nasal spray in a proprietary device as Amneal files an ANDA for a further generic version.
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