Read our latest updates & insights

On 21 February 2024, Regeneron announced that the FDA has accepted for priority review its BLA for Linvoseltamab for relapsed / refractory multiple myeloma.  The target action date is set for 22 August 2024.  Priority review was granted following data from a combined Ph 1 |...

On 21 February 2024, the US Patent Trial and Appeal Board (PTAB) entered an adverse judgment against Regeneron in inter partes review proceeding IPR2023-00462.  The IPR was commenced by Celltrion and Samsung Bioepis in relation to Regeneron’s aflibercept formulation patent ...

On 20 February 2024, BMS announced that FDA has accepted, for priority review, its supplemental new drug application (sNDA) for KRAZATI® (adagrasib) in combination with cetuximab for treating patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer.  ...

On 20 February 2024, FDA approved J&J ‘s supplemental biologics license application to use TECVAYLI® (teclistamab) with a reduced dosing frequency for cancer patients.  This approval increases dosing flexibility in patients on a weight-based dosing regimen.  TECVAYLI® w...

Health Canada announced that Celltrion’s Remsima™ SC (SC infliximab) has been approved for maintenance therapy in adults with moderate to severe active ulcerative colitis and Crohn’s disease.  Remsima™ SC was previously approved by Health Canada for RA on 28 January 2021.  ...

On 19 February 2024, AstraZeneca and Daiichi Sankyo announced that FDA has accepted its biologics license application (BLA) for the use of datopotamab deruxtecan in treating adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) w...

According to the Pharmaceutical Benefits Assessment Committee (PBAC) agenda for March 2024, published on 5 January 2024, the meeting will be jammed with biopharma applications for reimbursement.  The applications for PBS listing additions or amendments that the PBAC will co...

On 19 February 2024, the Korea Biomedical Review published that Celltrion secured a series of tenders to supply biosimilars in Peru including relating to Herzuma® (trastuzumab biosimilar),  Truxima® (rituximab biosimilar) and Yulfyma® (adalimumab).  These contracts effectiv...