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Value-Added Medicines

Set Alert for Value-Added Medicines

What’s Next? Five Things To Look Out For In June

Generics Bulletin previews the most notable and anticipated events for June 2023.

Biosimilars Generic Drugs

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.

Sales & Earnings Strategy

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.

Approvals Value-Added Medicines

What’s Next? Five Things To Look Out For In May

Generics Bulletin previews the most notable and anticipated events for May 2023.

Generic Drugs Biosimilars

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.

Regulation Europe

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.

Value-Added Medicines Complete Response Letters

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.

Strategy Generic Drugs

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.

Value-Added Medicines Clinical Trials

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.

Approvals United States
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