12 Dec 20 | Biopharma supplier Alexion announced it will be acquired by AstraZeneca. The acquisition is expected to close in Q3 2021 for total consideration to Alexion shareholders of $39bn. Under the deal,...
24 Nov 20 | Novartis released its annual report 'Meet Novartis Management 2020'. In the report, Novartis announced that GP2411 (biosimilar denosumab candidate) has commenced Ph III trials. Novartis also indicated it...
On 01 December NPS Medicine Wise published its annual list of the top 10 PBS drugs by cost to the Australian government. Biologics dominated the list, taking 7 of the top 10 places, including the top 5 positions. The...
The Generic and Biosimilar Medicines Association announced it has appointed Ms Jane Halton AO PSM as its inaugural Independent Chair. Halton will bring a wealth of experience to the role, as former head of the...
24 Nov 20 | Novartis released its annual report 'Meet Novartis Management 2020'. In the report, Novartis announced that GP2411 (biosimilar denosumab candidate) has commenced Ph III trials. Novartis also indicated it...
22 Nov 20 | Innovent released results of Ph III trials of Tyvyt® (sintilimab) with Byvasda® (biosimilar bevacizumab) as first-line treatment in patients with Advanced Hepatocellular Carcinoma (HCC). 24 Nov 20 | EU |...
In Pfizer Ireland Pharmaceuticals v Sandoz Pty Ltd [2020] FCA 1648, the Federal Court of Australia declined to order preliminary discovery against Sandoz, the holder of an ARTG registration for biosimilar etanercept,...
Significant biosimilar activities this week include 15 Nov 20 | US | Genentech filed a complaint against Centus Biotherapeutics, Fujifilm Kyowa Kirin Biologics, Fujifilm Corp and Kyowa Kirin relating to its proposed...
Significant biosimilar activities this week include 05 Nov 20 | Formycon announced its BLA resubmission strategy for FYB201 (proposed ranibizumab biosimilar) has been adjusted. The approval will now be requested...
Significant biosimilar activities this week include 05 Nov 20 | Teva released its Q3 2020 financial results, reporting a 2% increase in generic and biosimilar revenues in North America compared to Q3 2019. Teva...
Significant biosimilar activities this week include 22 Oct 20 | Ph III clinical trials of FYB202 (proposed ustekinumab biosimilar developed by Formycon and Bioeq) commenced recruiting in Poland. 26 Oct 20 | Samsung...
Significant biosimilar activities this week include 15 Oct 20 | Henlius and Essex announced they have entered into a co-development and exclusive license agreement for HLX04 (proposed bevacizumab biosimilar). Under the...
Significant biosimilar activities this week include 09 Oct 20 | CN | Innovent and Eli Lilly jointly announced China's NMPA has granted marketing approval for Halpryza® (biosimilar rituximab). Halpryza® is indicated for...
Next year, the UK will conclude its transition from the EU, with the regulation of all medicines and devices to be transferred from EMEA to the UK's Medicines and Healthcare products Regulatory Agency (MHRA). This...
Significant biosimilar activities this week include 05 Oct 20 | Medicure announced it has entered a License, Manufacture and Supply Agreement with Reliance Life Sciences for a cardiovascular biosimilar product for EU,...
Significant biosimilar activities this week include 28 Sep 20 | Innovent announced its Ph III trial of Byvasda® (proposed bevacizumab biosimilar) in combination with Tyvyt® (sintilimab) met its primary endpoints of...
The TGA has approved GW Pharma's Epidyolex® (cannabidiol) as an adjunctive therapy for seizures associated with Lennox-Gastaut syndrome or Dravet syndrome for patients over 2 years of age. Epidyolex® was developed by...
Significant biosimilar activities this week include 21 Sep 20 | EU | Alexion announced it has received a positive opinion from the EU's CHMP for a new 100mg/mL formulation of Ultomiris® (ravulizumab). The new...
Boutique specialist firm Pearce IP is delighted to announce that Senior Associate Alex May has commenced with Pearce IP. Alex is an intellectual property disputes lawyer with twelve years’ experience and a track record...
Significant biosimilar activities this week include 14 Sep 20 | Novartis announced the results of Ph III trials of Beovu® (brolucizumab) in diabetic macular edema. Novartis announced the trial met its primary and key...
The Australian Patent Office, in Ono Pharmaceutical Co., Ltd. et al [2020] APO 43, has emphatically confirmed that a patent term extension (PTE) request must be based on the first regulatory approval of a product...
Significant biosimilar activities this week include 08 Sep 20 | The Centre for Biosimilars reports a new study published in Diabetes Spectrum suggests FDA biosimilar naming requirements and switching restrictions cause...
Significant biosimilar activities this week include 31 Aug 20 | US | Mylan and Biocon announced the launch of Semglee® (insulin glargine) in vial and pre-filled pen presentations in the US. Semglee® is indicated for...
Significant biosimilar activities this week include 24 Aug 20 | JP | Merck announced Keytruda® (pembrolizumab) has received two additional approvals from the Japanese Pharmaceuticals and Medical Devices Agency: new...
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