Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd (No 4) [2024] FCA 678 (fedcourt.gov.au)
Date of decision:
18 June 2024
Body:
...
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By Naomi Pearce, Helen Macpherson | Sep 27, 2024
Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd (No 4) [2024] FCA 678 (fedcourt.gov.au)
Date of decision:
18 June 2024
Body:
...
By Bioblast Editor | Sep 26, 2024
In a short decision published on 26 September 2024, Justice Meade of the High Court of Justice of England and Wales has refused Janssen leave to appeal from a decision that the UK counterpart of Janssen’s European Patent No. EP 3883606, relating to the use of ustekinumab fo...
By Bioblast Editor | Sep 25, 2024
On 25 September 2024, Eli Lilly published three-year data for its atopic dermatitis treatment, Ebglyss™ (lebrikizumab-lbkz). The results, presented at the European Academy of Dermatology and Venereology (EADV), reportedly show that more than 80% of adults and adolescents w...
By Bioblast Editor | Sep 25, 2024
On 25 September 2024, MSD announced that Japan’s Ministry of Health, Labour and Welfare approved its Keytruda® (pembrolizumab) in combination with chemotherapy as a neoadjuvant treatment, then continued as monotherapy, for patients with non-small cell lung carcinoma (NSCLC)...
By Bioblast Editor | Sep 25, 2024
On 25 September 2024, Biocon Biologics Ltd announced new data on its adalimumab and ustekinumab biosimilars, presented at the 2024 European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam.
The first set of data is results from a Phase 3 study comp...
By Bioblast Editor | Sep 25, 2024
On 25 September 2024, Alvotech announced commencement of a Phase 3 clinical trial for AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab), in moderate to severe ulcerative colitis.
In August 2024, Intas Pharmaceutical received approval from India’s Central Drug Stan...
By Naomi Pearce, Helen Macpherson | Sep 25, 2024
Australian Mud Company Pty Ltd v Globaltech Corporation Pty Ltd (No 7) [2024] FCA 445 and Vald Pty Ltd v KangaTech Pty Ltd (Costs) [2024] FCA 693 (fedcourt.gov.au)
Austr...
By Pearce IP | Sep 24, 2024
We are thrilled to share that Pearce IP’s Founder and CEO, Naomi Pearce, a Finalist in the Lawyers Weekly Women in Law Awards 2024 “Executive of Year”.
Now in its 13th year,...
By Bioblast Editor | Sep 24, 2024
On 24 September 2024, Alvotech submitted a Citizen Petition to the FDA requesting that the FDA refuse to designate any ustekinumab biosimilar as “interchangeable” with Janssen’s Stelara® that is manufactured using a CHO cell-line system, until the FDA has evaluated th...
By Naomi Pearce, Chantal Savage, Nathan Kan | Sep 23, 2024
Aflibercept
19 September 2024 | EU | Sandoz & Samsung Bioepis/Biogen Aflibercept Biosimilars Recommended in Europe
At its September meeting, the European Medicines A...
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