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MSD and Daiichi Sankyo announced a global development and commercialisation collaboration involving Daiichi’s three deruxtecan antibody-drug conjugate candidates: patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan. The companies will jointly develop and...

AstraZeneca and Daiichi Sankyo announced that the European Commission (EC) has approved Enhertu® (trastuzumab deruxtecan) to treat a new indication: monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activa...

AstraZeneca announced that the Chinese National Medical Products Administration (NMPA) has approved Soliris® (eculizumab) to treat a new indication: neuromyelitis optica spectrum disorder (NMOSD).  Soliris® is the first and only complement inhibitor approved for the treatme...

The FDA approved Amgen’s Enbrel® (etanercept) on 18 October 2023 for a new indication: active juvenile psoriatic arthritis (JPsA) in paediatric patients 2 years of age and older.

On 21 March 2023, one of the largest studies to date examining etanercept biosimilar/ori...

On 17 October 2023, AbbVie announced that Health Canada has approved its Rinvoq® (upadacitinib) to for new indication: moderate to severely active Crohn’s disease.  This follows the recent Canadian approval (9 May 2023), of Rinvoq® for the treatment of Active Non-Radiograph...

AstraZeneca announced that the FDA accepted for Priority Review its supplemental New Drug Application (sNDA) for Tagrisso® (osimertinib) in combination with chemotherapy has been accepted and granted Priority Review in the US for the treatment of adult patients with locally...

Korea Biomed has reported that US pharmacy provider CarePartners Pharmacy will exclusively supply Celltrion’s biosimilar adalimumab (Yuflyma®) in the US.  It has removed AbbVie’s Humira® from its product line.  The partnership will be relevant to the supply of adalimumab to...

MSD made two announcements regarding new indications approved for Keytruda® (pembrolizumab):

In the US the FDA granted approval for the treatment of patients with resectable non-small cell lung cancer (NSCLC) in combination with platinum-containing chemotherapy as ...

A Zhejiang Hisun Pharmaceuticals sponsored study published in Frontiers in Pharmacology has found that HS016, biosimilar to AbbVie’s Humira® (adalimumab) was safe and effective in Chinese inflammatory bowel disease (IBD) patients.

Hisun completed its stage III clinic...