Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
BioBlast®
Biopharma News
Biosimilar Deals 2025
Biosimilar Deals 2026
Biosimilars Deals 2023
Biosimilars Deals 2024
Chantal Savage
Diversity
Helen Macpherson
Intranet
Kimberley Evans
Masterclasses
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Patents
Paul Johns
PipCast®
PTE
Trade Marks
Webinars

Home / News / Pearce IP Blog

PEARCE IP BLOG

Read our latest updates & insights

Stay informed about important legal and industry news with our blogs and weekly BioBlast® updates.

No Results Found

The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.

Recent BioBlast® Updates

MSD’s Sac-TMT Granted ‘Breakthrough Therapy’ Designation in US

Dec 4, 2024

On 3 December 2024, MSD, announced that sacituzumab tirumotecan (sac-TMT) has been granted Breakthrough Therapy designation by the FDA for advanced or metastatic NSCLC with epidermal growth factor receptor mutations whose disease progressed on or after tyrosine kinase...

Shanghai Henlius’ NDA for Pertuzumab Biosimilar Accepted in China

Dec 4, 2024

On 4 December 2024, Shanghai Henlius Biotech announced that an NDA for HLX11, biosimilar to Roche’s Perjeta® (pertuzumab), has been accepted by China's Center for Drug Evaluation of the National Medical Products Administration. The indications include: use in...

FDA Accepts sBLA for Genentech/Roche’s Columvi® Combination Therapy

Dec 4, 2024

On 4 October 2024, Genentech and Roche announced that the US FDA has accepted Roche’s supplemental biologics licence application (sBLA) for Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or...

FDA Grants Fast Track Designation to Corbus Pharmaceuticals’ CRB-701

Dec 3, 2024

On 3 December 2024, Corbus Pharmaceuticals announced that the US FDA has granted Fast Track designation to CRB-701 (SYS6002) for the treatment of relapsed or refractory metastatic cervical cancer.  CRB-701 (SYS6002) is an antibody drug conjugate targeting Nectin-4...

J&J Submits sBLAs for Tremfya® for PsO and jPsA

Dec 2, 2024

On 2 December 2024, Johnson & Johnson announced its submission of two supplemental Biologics License Applications (sBLAs) to FDA for approval of Tremfya® (guselkumab) for the treatment of children 6 years of age and older with moderate-to-severe plaque psoriasis...

Update on Challenges to Regeneron’s US Aflibercept Formulation Patent

Dec 2, 2024

On 2 December 2024, Formycon filed a petition for inter partes review of Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept, such as Eylea®. The petition closely followed a petition filed by Samsung Bioepis in relation to the same patent on 20 November 2024. Both petitions challenge the 865 patent for obviousness. Formycon has requested joinder of its petition with that of Samsung Bioepis.

China Adds Enhertu® to Health Insurance Plan

Nov 29, 2024

On 29 November 2024, Reuters reported that AstraZeneca and Daiichi Sankyo’s Enhertu® (trastazumab deruxtecan), will be added to China’s state-run health insurance scheme.  The addition of the drug, projected to be incorporated from early 2025, will aid in reducing the...

See Our BioBlast®

Get our Pearce IP Blogs & BioBlast® sent directly to your inbox

Subscribe to our Pearce IP Blogs and BioBlast® to receive our updates via email.

Subscribe here