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Value-Added Medicines

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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

Coherus Pulls A Rabbit Out Of The Hat With Inventive Pegfilgrastim Form

Coherus’ year-end financial results included a surprise – a newly approved formulation of pegfilgrastim.

Approvals Biosimilars

Rovi’s Value-Added US Risperidone Gets New Goal Date, Teva Ruled Out As Partner

Spain’s Laboratorios Farmacéuticos Rovi has a firm date to remedy issues observed in its application for a hybrid version of risperidone, developed using Rovi’s proprietary ISM drug-release technology platform.

Value-Added Medicines Complete Response Letters

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

Prepare for all the biggest industry actions and events in March 2023 with Generics Bulletin’s monthly column.

Biosimilars Generic Drugs

GGB Awards Returns To Barcelona In Its 10th Year

Celebrating its tenth anniversary year, the Global Generics & Biosimilars Awards 2023 will take place on Wednesday 25 October in Barcelona, Spain.

Generic Drugs Biosimilars

Hyloris Partner Signs To Market Maxigesic IV In Central And Eastern Europe

Hyloris’ partner AFT has signed an exclusive licensing and distribution agreement with Salus Pharmaceuticals covering nine central and eastern European countries. Meanwhile, Hyloris has also struck an in-licensing deal for a new blood phosphorus deficiency treatment. 

Europe Strategy

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

February brings a potentially sizeable launch in the US, multiple court cases in both the US and Europe and a gala generics and biosimilars event stretching across four days in Florida.

Biosimilars Generic Drugs

Teva-MedinCell Alliance Heats Up With Second Phase III Trial Underway

Teva’s partnership with MedinCell for long-acting injectable products, first penned a decade ago, is beginning to gather steam, as another candidate entered the clinic ahead of a potential first approval in the coming months.

Value-Added Medicines Clinical Trials
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