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BioBlast®

Celltrion files MAA with EMA for biosimilar to Janssen’s Stelara® (ustekinumab)

May 26, 2023

Korea Biomed has reported that Celltrion filed a marketing authorisatn application with the EMA for CT-P43, its biosimilar to Janssen’s Stelara® (ustekinemab). Based on its phase III clinical trial in plaque psoriasis patients, which demonstrated similar efficacy,...

FDA approves STADA-controlled Norbitec biologics facility to manufacture and store Pfizer’s Retacrit® (epoetin alfa-epbx) biosimilar to Amgen’s Epogen®/Procrit®

May 26, 2023

The Pharma Letter has reported that the STADA-controlled Norbitec biologics facility in Uetersen, Germany, has been approved by the FDA to manufacture and store Pfizer’s Retacrit® (epoetin alfa-epbx), biosimilar to Amgen’s Epogen®/Procrit®. The approval followed a...

New indication alert: AZ’s Ultomiris® (ravulizumab) approved for NMOSD

May 26, 2023

Astrazeneca announced that it has received approval in Japan for Ultomiris® (ravulizumab). Ultomiris is the first and only long-acting C5 complement inhibitor approved for preventing relapses in patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+)...

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Blog

BioBlast w/e 26 May 23

May 29, 2023

26 MAY 2023 | EU | Celltrion files MAA with EMA for biosimilar to Janssen’s Stelara® (ustekinumab) Korea Biomed has reported that Celltrion filed a marketing authorisation application with the EMA for CT-P43, its biosimilar to Janssen’s Stelara® (ustekinemab). Based...

Beware the shifting sands of patent term extensions (PTE) in Australia

May 25, 2023

Recent Australian decisions have resulted in both new opportunities to challenge patent term extensions in Australia and new patent prosecution practices to shield against them. We summarise here what is known about PTE, and the areas that are ripe for further...

BioBlast w/e 22 May 23

May 23, 2023

22 MAY 2023 | US | Janssen and Amgen settle Stelara® (ustekinemab) biosimilar patent dispute The US District Court of Delaware has dismissed with prejudice. The parties agreed to dismiss the action with prejudice and each party will bear its own costs, expenses and...

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Awards

Pearce IP leaders recognised as 2023 MIP Patent Stars

May 23, 2023

Pearce IP congratulates two of its leaders, Founder and CEO Naomi Pearce, and Special Counsel Jacinta Flattery-O’Brien PhD, who were honoured this week as MIP Patent stars for 2023. This is the third and fourth consecutive year (respectively) that they have been named...

Pearce IP’s Jacinta Flattery-O’Brien recognised in IAM Global Leaders 2023

Mar 3, 2023

Pearce IP congratulates Jacinta Flattery-O’Brien PhD on being ranked in the 2023 IAM Global Leaders. To qualify for inclusion in IAM Global Leaders, attorneys must be ranked in the gold tier of the IAM Patent 1000, the market-leading annual directory that identifies...

Naomi Pearce Shortlisted as a Finalist in Managing IP’s Practitioner of the Year for Australia.

Feb 24, 2023

We are excited to announce that Pearce IP’s Founder Naomi Pearce is one of 7 shortlisted last week by Managing IP for the Award of “Practitioner of the Year” for Australia for 2023, with the winner to be announced in Singapore in May. Naomi founded Pearce IP in 2017,...

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