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...
14 Apr 22 | CA | BIOJAMP announced the launch of SIMLANDI™/AVT02 (high-concentration, low volume, citrate-free biosimilar adalimumab) in Canada. JAMP Pharma has exclusive commercia...
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Biogen announced that it has withdrawn the MAA for aducanumab for the treatment of the early stages of Alzheimer’s disease, following feedback from the CHMP suggesting the data provided would not be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 ...
We recently reported on the decision in Pharmacia LLC v Juno Pharmaceuticals Pty Ltd [2022] FCA 92 in which the Federal Court found certain batches of Juno’s generic parecoxib produ...
Biogen reported that it has completed the sale of its stake in the Samsung Bioepis joint venture to Samsung Biologics. In January 2022 Biogen announced that it would sell its stake in Samsung Bioepis for an aggregate consideration of up to USD $2.3 billion.
11 Apr 22 | CA | Celltrion announced the launch of Yuflyma® (high-concentration, low-volume, citrate-free and latex-free biosimilar adalimumab) in Canada. Yuflyma® is approved in C...
An enlarged bench of the Full Court of the Federal Court has overturned a first instance decision, reported here, by confirming that artificial intelligence (AI) cannot be named as ...
Pearce IP publishes free e-books addressing various aspects of patent law and practice in Australia, with a focus on issues affecting pharmaceutical, biopharmaceutical and other life sciences companies.
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