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 specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries. Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.
In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.
Maliha Hoque
Paralegal
Maliha is a Paralegal and contributing author to Pearce IP’s flagship circulars BioBlast® and BioGxPulse®. She is currently completing her Juris Doctor at the University of Sydney. With a background in medical science, finance and risk consulting, and an inquisitive mind, Maliha loves leaving ‘no stone unturned’ when investigating IP/legal ‘challenges’. Maliha is interested in the intersection of law and science, and digital transformation. She gets excited about using her science, business management, and legal skills and experience to support Pearce IP’s lawyers, attorneys and clients.
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.