Supply of essential oil for topical use infringes method of treatment patent claims Justice Nicholas’ 96-page judgment in John Hood v Bush Pharmacy Pty Ltd [2020] FCA 1686 raises...
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...
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...
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...
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...
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...
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...
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...
Significant biosimilar activities this week include 15 Nov 20 | US | Genentech filed a complaint against Centus Biotherapeutics, Fujifilm Kyowa Kirin Biologics, Fujifilm Corp and...
Significant biosimilar activities this week include 05 Nov 20 | Formycon announced its BLA resubmission strategy for FYB201 (proposed ranibizumab biosimilar) has been adjusted....
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...
Significant biosimilar activities this week include 22 Oct 20 | Ph III clinical trials of FYB202 (proposed ustekinumab biosimilar developed by Formycon and Bioeq) commenced...
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...
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®...
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...
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...
Significant biosimilar activities this week include 28 Sep 20 | Innovent announced its Ph III trial of Byvasda® (proposed bevacizumab biosimilar) in combination with Tyvyt®...
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...
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...
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...
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...
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...
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...
Significant biosimilar activities this week include 24 Aug 20 | JP | Merck announced Keytruda® (pembrolizumab) has received two additional approvals from the Japanese...
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