A new study published in Cancer Communications concluded that Luye Pharmaceuticals’ LY01008 (proposed bevacizumab biosimilar) demonstrated similarity to reference Avastin® in terms of efficacy and safety in patients with advanced or recurrent non-squamous non-small cell lun...
Bioeq announced that it has submitted the MAA for FYB201 (proposed ranibizumab biosimilar) to the EMA. Under the agreement announced on 28 June 2021, FYB201 will be marketed in the EU by Teva.
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...
Teva and Bioeq announced they have entered into a strategic partnership for the exclusive commercialisation of Bioeq’s FYB201 (proposed ranibizumab biosimilar). Under the agreement, Bioeq will be responsible for the development, registration and supply of the product, while...
Innovent Biologics announced China’s National Medical Products Administration has approved its supplemental New Drug Application for Tyvyt® (sintilimab) in combination with Byvasda® (biosimilar bevacizumab) as a first-line treatment for people with advanced or unresectable ...
Following our recent announcement that Principal Naomi Pearce (Patent Star 2021) was honoured with a Managing IP (MIP) Patent Star 2021 awards, Pearce IP’s Special Counsel Patent At...
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, ...
Diagnostic tests that rely on a naturally occurring phenomenon patent eligible in Australia
On 18 June 2021, the Full Court of the Federal Court confirmed in Ariosa Diagnostic...
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.
Pearce IP publishes free e-books addressing various aspects of patent law and practice in Australia, with a focus on issues affecting pharmaceutical, biopharmaceutical and other life sciences companies.
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