23 Jun 21 | US | Genentechannouncedthatthe FDA has accepted the BLA for its Port Supply System with ranibizumab underneath Precedence Overview. Genentech is looking for approval for its PDSfor the therapy of moist, or neovascular, age-related macular degeneration (AMD).
23 Jun 21 | Innovent Biologics announced its Ph III trials of sintilimab together with chemotherapy met the general survival main endpoint.
24 Jun 21 | US | Medical health insurance supplier Cigna announced it should supply a one-time US$500 fee to sufferers who change to a biosimilar or one other most well-liked medicine. This fee shall be offered in a debit card and will be spent on well being care companies and merchandise.
24 Jun 21 | EU | The Committee for Medicinal Merchandise for Human Use (CHMP) recommended increasing the indications for Opdivo® (nivolumab) and Rinvoq® (upadacitinib). If accepted, Opdivo® may also be indicated for oesophageal or oesophageal junction most cancers. If accepted, Rinvoq® may also be indicated for atopic dermatitis.
24 Jun 21 | EU | The CHMP recommended granting conditional advertising and marketing authorisation for Minjuvi® (tafasitamab) for the therapy of relapsed or refractory diffuse massive B-cell lymphoma, and Abecma® (idecabtagene vicleucel) for the therapy of relapsed and refractory a number of myeloma.
25 Jun 21 | EU | Samsung Bioepis and Biogen announced that the CHMP has really helpful BYOOVIZ™/SB11 (proposed ranibizumab biosimilar) for the therapy of neovascular (moist) age-related macular degeneration, visible impairment on account of diabetic macular oedema, proliferative diabetic retinopathy, visible impairment on account of macular oedema secondary to retinal vein occlusion (department RVO or central RVO) and visible impairment on account of choroidal neovascularization.
25 Jun 21 | EU | UCB announced that the CHMP has really helpful BIMZELX® (bimekizumab) for the therapy of plaque psoriasis.