19 Mar 22 | US | Amgen and Pfizer settled their pegfilgrastim (Neulasta®) dispute Amgen Inc v Hospira Inc (D. Del., No. 20-201) which has been on foot since February 2020. No further details about the settlement agreement have been published to date.
21 Mar 22 | Henlius Biotech published the results of Ph II trials of novel anti-PD-1 monoclonal antibody serplulimab (novel anti-PD-1 mAb) in the treatment of advanced cervical cancer. Henlius reported that the study demonstrated a manageable safety profile and encouraging efficacy. Serplulimab is stated to be the first innovative mAb developed by Henlius.
21 Mar 22 | US | Merck announced that the FDA has approved Keytruda® (pembrolizumab) (anti-PD-1 therapy) as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Keytruda® is also indicated in combination with Lenvima® (lenvatinib) for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR.
22 Mar 22 | CA | The Government of British Columbia announced an expansion of its biosimilars switching program to include blood thinner enoxaparin. This change took effect on 22 March 2022, with all new PharmaCare approvals to be for biosimilar enoxaparin only.
22 Mar 22 | US | The FDA hosted a public meeting entitled ‘Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act’, in line with its previously stated commitment to do so no later than 30 September 2022.
25 Mar 22 | US | The Office of the Assistant Secretary for Preparedness and Response has announced that it will pause the distribution of sotrovimab in certain US states in which the BA.2 variant has become the dominant COVID-19 strain. This announcement follows FDA advice which indicates that sotrovimab is not effective against the BA.2 variant.
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