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Takeda and HUTCHMED announced that the FDA granted priority review for the NDA of fruquintinib, a selective inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3, for the treatment of previously treated metastatic colorectal cancer.  The Prescript...

Sandoz announced that the European Medicines Agency (EMA) has accepted marketing authorisation applications (MAA) for its proposed biosimilar denosumab, for regulatory review. The two applications include the approved indications for the originator drugs Prolia® and Xgeva®,...

Daiichi Sankyo announced that VANFLYTA® (quizartinib) has been approved in Japan for a new indication: the treatment of FLT3-ITD mutation positive acute myeloid leukemia (AML).  VANFLYTA® is now approved to treat these patients in combination with standard cytarabine and an...

As previously reported, on 22 May 2023 the US District Court of Delaware dismissed Janssen’s patent infringement case against Amgen pertaining to its Stelara® (ustekinumab) biosimilar with prejudice on the basis that each party bears its own costs. The proposed orders made ...

Celltrion announced that its Yuflyma® (adalimumab) product, a high-concentration formulation and biosimilar to AbbVie’s Humira®, has obtained FDA approval.  According to Celltrion, Yuflyma® will be available in the US from July for the key indications of Humira®, including ...

Mitsubishi Gas Chemical Company, Inc. and GlycoNex announced approval to commence a phase I clinical trial of SPD8 denosumab, biosimilar to Amgen’s Prolia®, from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).  The companies announced that the first patient ...

The National Institute for Health and Care Excellence (NICE) has issued a final appraisal document recommending MSD’s Keytruda® (pembrolizumab) combined with Eisai’s Lenvima® (lenvatinib) as an option for treating advanced or recurrent endometrial cancer in adults whose can...

Amgen filed a motion to intervene in the proceedings on foot between Regeneron and Mylan in West Virginia relating to aflibercept, and has sought to unseal certain documents. Amgen argued that the sealing of the documents blocked the public’s right of access to Court docume...