Read our latest updates & insights

Regeneron filed a Complaint in the US District Court for the Northern District of West Virginia against Celltrion asserting infringement of 38 US aflibercept patents.  The allegations relate to Celltrion’s abbreviated Biologics Drug Application (aBLA) filed with the US Food...

The FDA approved Eli Lilly’s Zepbound™ (Tirzepatide) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with a specified initial body mass index (BMI).  Tirzepatide is a glucose-dependent insulinotropic polypeptid...

Takeda announced that the US Food and Drug Administration (FDA) has approved Fruzaqla™ (fruquintinib) for the oral treatment of adults with Metastatic Colorectal Cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemot...

Samsung Bioepis and Organon announced that the US FDA has accepted for review their Supplemental Biologics License Application (sBLA) seeking interchangeability designation for Hadlima™ (adalimumab-bwwd) injection 40 mg/0.4 mL, biosimilar to Humira® (adalimumab).  The sBLA ...

The Korea Economic Daily reported that Celltrion announced record quarterly earnings, with an operating profit of ₩276.6 billion, an increase of 25.2% the same period in 2022, and estimated profit and revenue respectively of ₩220 billion and ₩620 billion.  Celltrion’s key m...

The US Food and Drug Administration (FDA) has revised the existing indication for Keytruda® (pembrolizumab) for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in c...

A pooled analysis study published in Pharmacology Research and Perspectives has concluded that the results support mAbxience’s MB02 bioequivalence to Genentech’s Avastin® (bevacizumab) (EU and US).  No clinically meaningful differences in safety or immunogenicity were obser...