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Amneal published its Q1 2022 financial results, reporting a 1% increase YoY in net revenue.  Amneal announced that it plans to expand into high growth areas including biosimilars and injectables.

The Kennedy Institute (Oxford University) published the results of Ph IIb trials of adalimumab in Dupuytren’s disease.  The researchers reported no related serious adverse events, and that the treatment was effective.  Although the half-life of adalimumab is two or three we...

Merck announced that the EC has approved Keytruda® (pembrolizumab) in combination with chemotherapy (with or without bevacizumab) for the treatment of persistent, recurrent or metastatic cervical cancer in adults whose tumours express PD-L1.

Korea Biomedical Review reported that Celltrion has a licence from AbbVie enabling the launch of Yuflyma® (Celltrion’s biosimilar adalimumab) in the US from July 2023.  Celltrion expects to receive approval for Yuflyma® this year.  Celltrion previously announced in February...

Amgen released its Q1 2022 financial results, reporting a 6% increase in YoY revenues. Amgen reported a 12% increase in Prolia® (denosumab) sales, a 7% decrease in Enbrel® (etanercept) sales, a 2% increase in Amgevita™ (biosimilar adalimumab) sales and a 40% decrease in Kan...

MSD announced that it received a positive CHMP opinion for its anti-PD-1 therapy Keytruda® (pembrolizumab) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy in adjuvant treatment after surgery for adults with locally advanced, or e...

Biogen announced that it has withdrawn the MAA for aducanumab for the treatment of the early stages of Alzheimer’s disease, following feedback from the CHMP suggesting the data provided would not be sufficient to support a positive opinion.

Australia’s TGA granted orphan drug designation to Roche’s glofitamab.  The TGA also provided approval for Roche to apply for registration using the provisional approval pathway, an expedited approval process.  Roche has until 21 October 2022 to make an application through ...