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Dr. Reddy’s and Coya Therapeutics today announced that they have entered into a development and license agreement for the development and commercialisation of COYA302, an investigational combination therapy for the treatment of Amyotrophic Lateral Sclerosis (ALS).  COYA302 ...

SystImmune and Bristol Myers Squibb announced that they have entered into an exclusive  global license and collaboration agreement for SystImmune’s BL-B01D1, a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate.  Under the agreement the companies will j...

Bristol Myers Squibb (BMS) announced that the FDA has accepted for priority review its supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable o...

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.