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MSD announced positive results in two studies evaluating Keytruda®, its anti-PD-1 therapy.   
MSD reported that its Phase 3 KEYNOTE-671 trial evaluating Keytruda® plus chemotherapy before surgery and continued as a single agent after surgery showed reduced risk of dis...

Innovent announced that it has entered into a clinical trial collaboration and supply agreement with Merck KgGA for a combination therapy of IBI351 (GFH925) with cetuximab (ERBITUX®).  Innovent says the therapy is a potential treatment for non-small cell lung cancer (NSCLC)...

Novartis announced that the European Commission (EC) has approved its Cosentyx® (secukinumab) for a new indication to treat active moderate to severe hidradenitis suppurativa (HS) in adult patients who have had an inadequate response to conventional systemic HS therapy.  Th...

Coherus announced it is launching YUSIMRY® (adalimumab-aqvh) biosimilar to AbbVie’s Humira®, in July 2023 with a list price of $995 per carton.  This is the lowest price announced of any adalimumab product in the US, and represents an 85% discount on the originator product....

Celltrion has received marketing authorization from the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) for Remsima® SC, biosimilar to Janssen’s Remicade® (infliximab). It has been approved for the full range of indications previously approved for Remic...

Sanofi-Aventis filed one of the earliest UPC revocation cases against Amgen’s Repatha® (evolocumab) patent EP3666797 in Munich on 1 June 2023, the day of the UPC’s commencement. Evolocumab is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin t...

The FDA announced that it has approved AstraZeneca’s Lynparza® (olaparib) with abiraterone and prednisone (or prednisolone) for patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an FDA-approved ...

Celltrion has released its clinical phase I data for its tocilizumab product CT-P47, biosimilar to Roche’s Actemra® which it announced at the 2023 European Congress of Rheumatology (2023 EULAR).  Celltrion has successfully demonstrated pharmacodynamic equivalence and safety...