04 Feb 2021 | Roche reported a huge erosion of its year on year CER growth in key areas, attributing this decline to COVID-19 impacts and biosimilars. Roche reported the YoY CER...
Pearce IP BioBlast®: w/e 12 February 2021
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Exclusive licensees: are you stuck in a “No Standing” zone?
Under Australian law, patent infringement proceedings may be started in the Australian Federal Court only by a patentee or an exclusive licensee.[1] When it comes to determining...
TGA seeks consultation on issues relating to the registration of off-label use of medicines: Part 1
TGA has invited submissions on its consultation paper released last Thursday designed to facilitate indication "repurposing", a phrase coined by TGA to describe the Australian...
Pearce IP BioBlast®: w/e 05 February 2021
29 Jan 21 | EU | The CHMP recommended 13 medicines for approval. Among the recommendations were two bevacizumab biosimilars, Mabxience's Alymsys® and STADA's Oyavas®. 01 Feb 21 |...
Pearce IP BioBlast®: w/e 29 January 2021
25 Jan 21 | Samsung Bioepis announced the opening of its new headquarters in Incheon. The building was complete in December 2020, and will house approximately 1000 new employees,...
Pearce IP BioBlast®: w/e 22 January 2021
18 Jan 21 | Prestige Biopharma announced it is set for an IPO in early February 2021. The IPO is expected to be worth US $348 million, with the majority of the funds to be...
Pearce IP BioBlast™: w/e 15 January 2021
07 Jan 21 | ADQ announced it will acquire Pharmax Pharmaceuticals, as well as investing in a minority stake in Biocon Biologics. 13 Jan 21 | Kamada announced it has entered into...
Clinical trial information can invalidate an Australian patent
On 5 November 2020, the High Court of Australia refused a special leave application by Mylan Health Pty Ltd to appeal the decision of the Full Federal Court (FFC) in which three...
Pearce IP BioBlast™: w/e 08 January 2021
05 Jan 21 | EU | The Centre for Biosimilars reported a study presented at the 2020 San Antonio Breast Cancer Symposium found strong uptake of Amgen's Kanjinti (biosimilar...
Pearce IP BioBlast™: w/e 01 January 2021
27 Dec 20 | CN | Innovent announced China's NMPA has approved Byvasda® (biosimilar bevacizumab) for the additional indication of adult recurrent glioblastoma. 30 Dec 20 |...
Pearce IP BioBlast™: w/e 25 December 2020
21 Dec 20 | Celltrion announced Ph III trials of its proposed ustekinumab biosimilar CT-P43 will be completed by the second half of 2022. Celltrion also announced plans to launch...
Supply of essential oil for topical use infringes method of treatment patent claims
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...
Pearce IP BioBlast™: w/e 18 December 2020
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...
Pearce IP BioBlast™: w/e 11 December 2020
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...
Biologics dominate list of costliest drugs
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...
Jane Halton appointed as GBMA Chair
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...
Pearce IP BioBlast™: w/e 04 December 2020
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...
Pearce IP BioBlast™: w/e 27 November 2020
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...
Preliminary discovery not justified by fear of a future product launch
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...
Pearce IP BioBlast™: w/e 20 November 2020
Significant biosimilar activities this week include 15 Nov 20 | US | Genentech filed a complaint against Centus Biotherapeutics, Fujifilm Kyowa Kirin Biologics, Fujifilm Corp and...
Pearce IP BioBlast™: w/e 13 November 2020
Significant biosimilar activities this week include 05 Nov 20 | Formycon announced its BLA resubmission strategy for FYB201 (proposed ranibizumab biosimilar) has been adjusted....
Pearce IP BioBlast™: w/e 06 November 2020
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...
Pearce IP BioBlast™: w/e 30 October 2020
Significant biosimilar activities this week include 22 Oct 20 | Ph III clinical trials of FYB202 (proposed ustekinumab biosimilar developed by Formycon and Bioeq) commenced...
Pearce IP BioBlast™: w/e 23 October 2020
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...
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