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The Canadian Federal Court has refused AbbVie’s application for a permanent injunction against JAMP for exploitation of Simlandi® until the expiration of AbbVie’s Humira® patent no. 2,904,458.  Despite JAMP conceding it infringed the ‘458 patent, it successfully argued that...

Roche and Carmot Therapeutics announced a US$2.7B agreement for Roche to acquire Carmot Therapeutics, including its R&D portfolio of clinical stage incretins.  The deal also provides for potential additional milestone payments of up to US$400M.

As part of the acq...

New Zealand’s Pharmac has listed Celltrion’s Herzuma®, biosimilar to Genentech’s Herceptin®, on the Pharmaceutical Schedule for the treatment of breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology). Patients taking Herceptin® will need ...

The Korea Biomedical Review reported that Celltrion has submitted an application for marketing authorisation to the FDA for CT-P41, its biosimilar to Amgen’s Prolia® (denosumab) for the treatment of osteoporosis and related diseases.  The KBR reported that Celltrion has con...

Syngene announced that it has completed the acquisition of a biologics manufacturing facility from Stelis Biopharma (a subsidiary of Strides Pharma Science, located in Bangalore).  Sygene announced the acquisition in July 2023.

Samsung announced that it has signed a settlement and licence agreement with Johnson & Johnson settling all pending US patent litigation between the companies, with a licence to Samsung to commercialise its Stelara (ustekinumab) biosimilar SB17 in the US from 22 Februar...

Merck announced that the FDA has accepted for priority review its new supplemental Biologics License Application (sBLA) seeking approval for Keytruda® in combination with Seagen/Astellas’ Padcev® (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of ad...

Regeneron filed a Complaint in the US District Court for the Northern District of West Virginia against Formycon asserting infringement of 39 US aflibercept patents.  The heavily redacted Complaint states that on 29 August 2023 Formycon announced its aBLA for FYB203 was acc...

Alvotech announced that its pharmacokinetic study of AVT05, its Simponi®/Simponi Aria® (golimumab) biosimilar, met its primary endpoint.  The study assessed the pharmacokinetics, safety and tolerability of AVT05 compared to Simponi® in healthy adult subjects.

Alvotec...