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Daiichi Sankyo and AstraZeneca announced that the FDA has offered accelerated approval to Enhertu® (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumours have activating HER2 mutations.  Continue...

Roche announced that the FDA has approved the use of its Ventana® MMR RxDx Panel as the first immunohistochemistry companion diagnostic test to aid in identifying patients who may be eligible for treatment with Keytruda®.  The panel is used to identify patients whose solid ...

ALX Oncology announced the initiation of Ph II trials of evorpacept (CD47 blocker) in combination with Erbitux® (cetuximab) and Keytruda® (pembrolizumab) for the treatment of refractory microsatellite stable metastatic colorectal cancer following at least two lines of syste...

The IPRs (inter-partes reviews) commenced by Mylan against Regeneron’s Eylea® patents 9,669,069 and 9,254,338 (instituted in December 2021) were heard by the PTAB together on 10 August 2022.  The patents relate to Regeneron’s blockbuster product Eylea® (aflibercept) and ana...

Significant biosimilar activities this week include:

27 Jul 22 | AU | Viatris (Mylan) seeks PBS listing for etanercept biosimilar

Alphapharm (Viatris’ Australian subsidiary) has its etanercept biosimilar, Nepexto®, on the agenda for the November PBAC meeting. ...

Pearce IP’s Naomi Pearce speaks about the hot topic in Australian patent law: Patent Term Extension (PTE) in Australia

Amgen announced that it has agreed to acquire ChemoCentryx, a biopharmaceutical company focused on auto-immune diseases, inflammatory disorders and cancer, for around $3.7 billion.  ChemoCentryx markets Tavneos® (avacopan), a first-in-class treatment for multi-system autoim...

In its earnings call on 4 August 2022, Coherus announced that it is developing a high concentration adalimumab formulation, which it intends to market following launch of its 50mg/ml citrate-free Yusimry™ formulation in July 2023.  Coherus also shared its plans to capture “...

Regeneron has filed a complaint against Mylan in West Virginia under the BPCIA alleging infringement of twenty-four patents relating to Eylea® (aflibercept).  This follows the FDA’s acceptance for review of Mylan’s aBLA for its aflibercept biosimilar.  Regeneron recently li...