Aflibercept
18 October 2024 | Regeneron Announces 3-Year Results for High Dose Eylea® (Aflibercept)
On 18 October 2024, Regeneron announced positive three year results for Eylea HD® (aflibercept, 8 mg injection) from an extension study of the Phase 3 PHOTON trial in patients… Read more here.
Bimekizumab
14 October 2024 | US | FDA Approves UCB’s 320mg Single-Injection Device Presentations of Bimzelx® (Bimekizumab)
On 14 October 2024, UCB announced that the US FDA has approved a 2 mL pre-filled syringe and pre-filled autoinjector, each containing 320 mg of Bimzelx® (bimekizumab-bkzx)… Read more here.
Catumaxomab, Concizumab
17 October 2024 | EU | CHMP Delivers Good News for Novo Nordisk, Lindis, Sanofi and BeiGene
At its October 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for… Read more here.
Daratumumab
15 October 2024 | J&J Reports Q3 2024 Results as Sales of Darzalex® Reach USD $3B
On 15 August 2024, Johnson & Johnson (J&J) reported its results for Q3 2024, which saw sales growth of 5.2% to $22.5B. J&J’s significant regulatory announcements this… Read more here.
Lecanemab
16 October 2024 | AU | ‘Blow’ to Australia’s Alzheimer’s Patients – TGA Rejects Eisai’s Leqembi® (Lecanemab) Due To Safety & Efficacy Concerns
On 16 October 2024, Australia’s Therapeutic Goods Administration (TGA) reported its decision not to register Leqembi® (lecanemab) for the treatment of patients with… Read more here.
Marstacimab
11 October 2024 | US | Approval Alert: US Approval of Pfizer’s Hympavzi™ (Marstacimab) for Haemophilia
On 11 October 2024, Pfizer announced that the US FDA has approved its Hympavzi™ (marstacimab-hncq) for the treatment of adults and adolescents with haemophilia A or B… Read more here.
Nivolumab
9 October 2024 | TW | Ono’s Opdivo® Combination Therapy Approved in Taiwan for Urothelial Carcinoma
On 9 October 2024, Ono Pharma Taiwan received additional approval of Opdivo® (nivolumab) intravenous infusion in combination with cisplatin and gemcitabine, from the… Read more here.
Nivolumab, Pembrolizumab
18 October 2024 | AU | PBAC Guidance Means Broad, Multi-Cancer Funding Agreements for PD-(L)1 Inhibitors Unlikely in AU
On 18 October 2024, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC), published the outcomes of its September 2024 intracycle meeting. This included… Read more here.
Pembrolizumab
16 October 2024 | Formycon’s Pembrolizumab Biosimilar Demonstrates Keytruda® Similarity
On 16 October 2024, Formycon announced that results of a comparative analytical evaluation of its FYB206, published in Drugs in R&D, showed FYB206 to be structurally… Read more here.
8 October 2024 | UK | Keytruda®/Padcev® Combination Therapy for Bladder Cancer Approved in UK
On 8 October 2024, MSD’s Keytruda® (pembrolizumab) and Astellas/Pfizer’s Padcev® (enfortumab vedotin) were approved by the Medicines and Healthcare products Regulatory… Read more here.
Pertuzumab
16 October 2024 | IN | Delhi High Court Reinstates Injunction Against Zydus’ Pertuzumab Biosimilar
On 16 October 2024, the Economic Times reported that the Delhi High Court has reinstated an injunction preventing Zydus from manufacturing, selling or marketing… Read more here.
Semaglutide, Insulin degludec, Insulin aspart
16 October 2024 | Gan & Lee Pharmaceuticals Enters the GLP-1 Agonist Weight Loss Market with Ozempic® Competitor GZR18
On 16 October 2024, Chinese insulin maker Gan & Lee Pharmaceuticals reported its development of an injectable GLP-1 agonist, GZR18, which it claims has outperformed… Read more here.
Tocilizumab
17 October 2024 | CA | Fresenius Kabi Launches First Tocilizumab Biosimilar in Canada
On 17 October 2024, Fresenius Kabi announced its Canadian launch of Tyenne®, biosimilar to Roche’s Actemra® (tocilizumab), in both IV and subcutaneous formulations… Read more here.
Trastuzumab deruxtecan
14 October 2024 | CN | AstraZeneca/Daiichi’s Enhertu® Receives Conditional Approval in China
On 14 October 2024, AstraZeneca, in partnership with Daiichi Sankyo, announced that Enhertu® (trastuzumab deruxtecan) has received conditional approval in China… Read more here.
Ustekinumab
17 October 2024 | EU | CHMP Adopts Positive Opinions for Accord Ustekinumab Biosimilars
At its October meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Accord… Read more here.
Zolbetuximab
18 October 2024 | US | Approval Alert: FDA Approves Astellas Pharma’s Zolbetuximab
On 18 October 2024, Astellas Pharma announced that the FDA has approved VyloyTM (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing… Read more here.
About Pearce IP
Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech). Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022. Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.
Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.
Naomi Pearce
CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)
Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.
Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.
Chantal Savage
Special Counsel, Lawyer
Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.
With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.
Nathan Kan
Graduate (Law)
Nathan is a Graduate (Law) focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.
Nathan is passionate about the intersection of law and science. Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.