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At its June 2024 meeting, EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Celltrion’s Steqeyma (CT-P43), biosimilar to Janssen’s Stelara® (ustekinumab).  The recommendation is for moderately to severely active Crohn’s disease, plaqu...

On 27 June 2024, Harbour Biomed announced that it has resubmitted its Biologics License Application (BLA) for batoclimab (HBM9161) to the China’s National Medical Products Administration (NMPA) for the treatment of generalized myasthenia gravis. The resubmission voluntarily...

Novo Nordisk announced that Wegovy® has been approved in China for long-term weight management, targeting patients with a BMI of 30kg/m² and at least one weight-related comorbidity.   

The approval comes as the company plans a $4.1 billion expansion of its US manufac...

On 25 June 2024, Simcere Zaiming announced the approval of Enlituo® (cetuximab beta) in the PRC for use in combination with the FOLFIRI regimen as a first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC). The drug was developed in collaboration with...

On 26 June 2024, AbbVie announced that its Epkinly® (epcoritamab) received FDA approval for the treatment of adults with relapsed or refractory follicular lymphoma.  This approval makes Epkinly® the first and only subcutaneous bispecific antibody approved in the US to treat...

On 25 June 2024, Novo Nordisk announced its plan to significantly boost its investment in manufacturing in 2024, allocating USD $6.8 billion towards production.  This is up from USD $3.9 billion the previous year.  

The plan includes a USD $4.1 billion investment to ...

Business Korea reports that Samsung Biologics has entered a contract manufacturing agreement with US based Kiniksa Pharmaceuticals. The deal, valued at approximately USD $156m (211b won) covers the period 21 June 2024 to 31 December 2031. 

This follows the announceme...

On 25 June 2024, Celltrion announced that its Omlyclo (CT-P39), biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab), was approved by the Korean Ministry of Food and Drug Safety for allergic asthma and chronic idiopathic urticaria.  This is the first omalizumab bios...