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.
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...
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...
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...
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...
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...
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.
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...
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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