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From 4-8 October 2024, Novo Nordisk and each of Mylan Pharmaceuticals (a subsidiary of Viatris), Dr Reddy’s, Apotex and Sun Pharma filed joint motions notifying the US Patent Trial and Appeal Board (PTAB) that they had settled their dispute regarding the validity of Novo No...

On 4 October 2024, Amgen filed a BPCIA complaint against Fresenius Kabi in the US District Court for the Northern District of Illinois (Eastern Division) asserting infringement of 33 US patents relating to denosumab and methods of its manufacture.

The litigation foll...

On 4 October 2024, Daiichi Sankyo announced that it has submitted a supplemental new drug application for Enhertu® (trastuzumab deruxtecan) to Japan’s Ministry of Health, Labour and Welfare.  The application proposes use of Enhertu® in adult patients with HER2 low (IHC 1+ o...

On 3 October 2024, BMS announced that the FDA has approved Opdivo® (nivolumab) for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrange...

On 3 October 2024, the US Patent Trial and Appeal Board (PTAB) instituted inter partes review (IPR) of Johns Hopkins University’s US patent no. 11,643,462 in IPR2024-00648.  MSD filed a petition on 13 March 2024, challenging the validity of the patent, which is directed to ...

On 3 October 2024, Teva Pharmaceuticals and mAbxience (majority owned by Fresenius Kabi) each announced that they have entered into a new global licensing agreement for the development of an unnamed anti PD-1 oncology biosimilar candidate.  Under the agreement, mAbxience wi...

The UK National Health Service (NHS) launched a consultation on a phased rollout of Eli Lilly’s obesity drug Mounjaro® (tirzepatide), prioritising patients who are most likely to benefit from weight loss.  In a proposal made to National Institute for Health and Care Excelle...

On 2 October 2024, Eisai reported that it has submitted an application for approval of Leqembi® (lecanemab) in Saudi Arabia for Alzheimer’s disease .

The news follows approval of Leqembi® in the UK for the treatment of mild cognitive impairment (MCI) and mild dementi...