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Pearce IP BioBlast®: w/e 25 June 2021

by | Jun 28, 2021

23 Jun 21 | US |Genentech announced that the FDA has accepted the BLA for its Port Delivery System with ranibizumab under Priority Review. Genentech is seeking approval for its PDS for the treatment of wet, or neovascular, age-related macular degeneration (AMD).

23 Jun 21 | Innovent Biologics announced its Ph III trials of sintilimab in combination with chemotherapy met the overall survival primary endpoint. 

24 Jun 21 | US | Health insurance provider Cigna announced it will offer a one-time US$500 payment to patients who switch to a biosimilar or another preferred medication. This payment will be provided in a debit card and can be spent on health care services and products.  

24 Jun 21 | EU | The Committee for Medicinal Products for Human Use (CHMP) recommended expanding the indications for Opdivo® (nivolumab) and Rinvoq® (upadacitinib). If approved, Opdivo® will also be indicated for oesophageal or oesophageal junction cancer. If approved, Rinvoq® will also be indicated for atopic dermatitis.  

24 Jun 21 | EU | The CHMP recommended granting conditional marketing authorisation for Minjuvi® (tafasitamab) for the treatment of relapsed or refractory diffuse large B-cell lymphoma, and Abecma® (idecabtagene vicleucel) for the treatment of relapsed and refractory multiple myeloma. 

25 Jun 21 | EU | Samsung Bioepis and Biogen announced that the CHMP has recommended BYOOVIZ™/SB11 (proposed ranibizumab biosimilar) for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularization. 

25 Jun 21 | EU | UCB announced that the CHMP has recommended BIMZELX® (bimekizumab) for the treatment of plaque psoriasis. 

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