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MSD announced the US Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA®, MSD’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin chemotherapy for the treatmen...

Eisai and Biogen announced that Eisai filed a marketing authorisation application (MAA) for LEQEMBI® (lecanemab) for treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology in t...

Samsung Biologics announced that it will accelerate the construction and completion of Plant 5, which will now be in operation by April 2025.  The plant will add 180,000L capacity to Samsung Biologics’ capabilities, so it will maintain the world’s largest biomanufacturing c...

The US District Court for the Northern District of West Virginia has granted Regeneron’s motion for judgment dismissing Mylan’s inequitable-conduct counterclaims regarding two Eylea® (aflibercept) patents (US patent nos. 10,888,601 and 11,235,572).  Chief Judge Thomas Kleeh...

Dr Reddy’s Laboratories announced completion of a successful phase I clinical trial of DRL_TC, its biosimilar to Genentech’s Actemra® (tocilizumab) by intravenous route.  The study demonstrated the pharmacokinetic equivalence, safety, and immunogenicity of DRL_TC compared t...

Rani Therapeutics announced that it has expanded its partnership with Celltrion to develop an orally administered adalimumab biosimilar RT-105, following their previous collaboration on an ustekinumab biosimilar.  The partnership allows Rani to use Celltrion’s adalimu...

Samsung Biologics revealed in a regulatory filing with Korea Exchange that it has signed a US$81M CMO contract with a ‘European pharmaceutical company’.  The contract amount is 3.58% of sales and is binding on the two companies.  Samsung said that when the main contract is ...