Following a trend of cases being filed by employers against ex-employees in the Federal Court for breach of confidence and copyright infringement, Justice Jackson in Austin Engineer...
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By Naomi Pearce, Eliza Jane Saunders, Sian Hope | Jun 02, 2023
Following a trend of cases being filed by employers against ex-employees in the Federal Court for breach of confidence and copyright infringement, Justice Jackson in Austin Engineer...
By Pearce IP | Jun 01, 2023
Pearce IP, an award-winning Australian boutique Intellectual Property firm, specialising in the pharma, biopharma and life sciences industries, has joined Australia’s peak body for ...
By Naomi Pearce, Sian Hope | 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 app...
By Bioblast Editor | 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, pharmaco...
By Bioblast Editor | 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 six-day ...
By Bioblast Editor | 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+) neuromyelitis o...
By Bioblast Editor | May 26, 2023
Bristol Myers Squibb announced that the EMA CHMP recommended the approval of Opdivo® (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) with a high risk of recurrence in adult patients w...
By Bioblast Editor | May 26, 2023
AstraZeneca announced that its Ultomiris® (ravulizumab) has a new indication approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) as the first and only long-acting C5 complement inhibitor for the prevention of relapses in patients with anti-aquaporin-4 (AQ...
By Naomi Pearce, Eliza Jane Saunders, Chris Vindurampulle | 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 summ...
By Bioblast Editor | May 25, 2023
Takeda and HUTCHMED announced that the FDA granted priority review for the NDA of fruquintinib, a selective inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3, for the treatment of previously treated metastatic colorectal cancer. The Prescript...
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