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On 10 August 2023, Regeneron announced the results of two-year (96 week) data from its PULSAR trials investigating aflibercept 8mg in wet age-related macular degeneration.  Regeneron reported that aflibercept 8mg demonstrated durable vision gains at extended dosing interval...

The UPC has appointed 21 new technically qualified judges (TQJs) across various areas, including chemistry and pharmaceutics, biotechnology, mechanical engineering, electricity and physics.  Following a selection process, the UPC Administrative Committee adopted the final l...

The USPTO Patent Trial and Appeal Board has terminated Samsung Bioepis’s Inter Partes Review (IPR) challenging Janssen’s US patent 10,961,307 relating to Stelara® (ustekinumab).  The Board’s decision follows Samsung and Janssen’s joint motion, dated 3 August 2023, stating t...

News is my Business reported that the Puerto Rico Economic Development Bank (BDE) has approved US$3.85M in funding for Biosimilar Sciences PR LL and Ocyon Bio PR Inc. to facilitate the purchase of specialised biotechnology equipment. This funding comes from the US Treasury&...

Regeneron filed an unopposed motion to terminate IPR2023-00620 after disclaiming all claims of the US process patent no 10,406,226. Celltrion filed the IPR in February 2023, and it had not yet been instituted by the PTAB.  All claims of the ‘226 patent relate to a method of...

Fresenius Kabi and Formycon AG announced they reached a settlement in the US with Johnson & Johnson relating to their ustekinumab (FYB202), biosimilar to Stelara®.  As part of the agreement, Fresenius and Formycon can launch in the US “no later than 15 April 2025”.  The...

On 7 August 2023 Gingko Bioworks and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the US and Canada) announced a collaboration to improve biologic manufacturing.  Gingko will “apply its expertise and capabilities in cell engineering, ultra high-throughput mu...