27 Jun 21 | CN | Innovent Biologics announced China’s National Medical Products Administration has approved its supplemental New Drug Application for Tyvyt® (sintilimab) in combinat...
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By Naomi Pearce | Jul 05, 2021
27 Jun 21 | CN | Innovent Biologics announced China’s National Medical Products Administration has approved its supplemental New Drug Application for Tyvyt® (sintilimab) in combinat...
By Bioblast Editor | Jul 05, 2021
Chong Kun Dang announced it has signed a commercialisation agreement with Menagen for Nesbell® (biosimilar darbepoetin alfa). Under the agreement, Chong Kun Dang will receive a down payment and milestone payments in exchange for exclusive commercialisation rights in Oman, S...
By Bioblast Editor | Jul 02, 2021
Gan & Lee Pharmaceuticals announced positive Ph I results for its three proposed insulin analog biosimilars (insulin aspart, insulin lispro and insulin glargine). Gan & Lee announced that all three Ph I studies met their primary PK and primary PD analyses.
By Pearce IP | Jul 02, 2021
Pearce IP recently reported on the Full Court of the Federal Court decision in Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101, which confirmed that a method of detecting c...
By Pearce IP | Jul 01, 2021
Pearce IP is proud to announce that our team has once again been ranked among the best patent practitioners in Australia by IAM Patent 1000. Both our litigation and prosecution team...
By Naomi Pearce | Jun 30, 2021
A new report demonstrates that female-dominated inventor teams in biomedical sciences are more likely to invent female-focused inventions, but a lack of majority female inventor tea...
By Naomi Pearce | Jun 30, 2021
Date: 30 June 2021Court: Full Court of the Federal Court of AustraliaJudges: Yates, Moshinsky and Burley JJ
Background
The case concerns Australian Patents 2003200627 (6...
By Pearce IP | Jun 29, 2021
Pearce IP is proud to announce that our team of patent and trademark lawyers and attorneys has been selected as a finalist for the Intellectual Property Team of the Year 2021 in the...
By Bioblast Editor | Jun 29, 2021
STADA and XBrane BioPharma announced that Xlucane™ (proposed ranibizumab biosimilar) met its primary endpoint in a pivotal comparability trial. STADA disclosed that it plans to submit the MAA and BLA for Xlucane™ to the EMA and FDA respectively in the second half of 2021.
By Bioblast Editor | Jun 29, 2021
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...
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