Read our latest updates & insights

The FDA approved Vertex/CRISPR Therapeutics’ Casgevy® and Bluebird Bio’s Lyfgenia®, the first cell-based gene therapies to treat sickle cell disease in patients 12 years and older.  Casgevy® is the first FDA-approved treatment that uses CRISPR/Cas9 to genetically modify a p...

Bio-Thera announced that its Avzivi® (BAT1706), biosimilar to Genentech’s Avastin® (bevacizumab) is FDA approved with a full indication set (excluding hepatocellular carcinoma).  Bio-Thera is the only Chinese company to have received marketing approval for a biosimilar in t...

The National Institute for Health and Care Excellence (NICE) issued final draft guidance recommending AstraZeneca/MSD’s Lynparza® (olaparib) with bevacizumab be routinely used in the NHS in England and Wales for maintenance treatment of high-grade epithelial ovarian, ...

The US Patent Trial and Appeal Board (PTAB) has instituted Samsung Bioepis’ inter partes review (IPR) petition challenging Regeneron’s Eylea® (aflibercept) patent no. 10,464,992 in IPR proceeding IPR2023-01312.  The patent claims formulations of aflibercept suitable for int...

The US Patent Trial and Appeal Board (PTAB) has instituted three of Samsung Bioepis’ inter partes reviews (IPR) petitions challenging Alexion’s Soliris® (eculizumab) patent nos. 9,725,504, 9,718,880 and 9,732,149 in IPR proceedings IPR2023-00999, IPR2023-00998 and IPR2023-0...

Bioeq and Teva jointly announced that Health Canada granted a Notice of Compliance for Ranopto® (ranibizumab), biosimilar to Genentech’s Lucentis® (ranibizumab).  Ranopto® is indicated for the treatment of neovascular (wet) age-related macular degeneration, the treatment of...

Carefirst and another Blue Cross/Blue Shield licensee have brought class action proceedings against Johnson & Johnson (J&J) and Janssen alleging that the companies unlawfully delayed the introduction of biosimilar competition for its Stelara® ustekinumab product ont...

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...