Aflibercept
23 October 2024 | Biocon Switching Study for Aflibercept Confirms Safety & Efficacy
On 23 October 2024, Biocon announced follow-up results from a Phase 3 study of MYL-1701P, biosimilar to Regeneron’s Eylea® (aflibercept). According to Biocon, the study… Read more here.
22 October 2024 | US | Regeneron Fails to Injunct Amgen’s US Aflibercept Biosimilar for Second Time; Amgen to Launch At Risk
On 22 October 2024, the United States Court of Appeals for the Federal Circuit ruled that Regeneron was not entitled to an injunction preventing Amgen from launching its aflibercept… Read more here.
Daratumumab
23 October 2024 | EU | New Indication Alert: J&J’s Darzalex® (Daratumumab) Quadruplet Regimen for Multiple Myeloma Approved in the EU
On 23 October 2024, Johnson & Johnson (J&J) announced that the European Commission has approved an indication extension for Darzalex® (daratumumab) subcutaneous… Read more here.
Donanemab
23 October 2024 | UK | Approval Alert: Eli Lilly’s Kisunla™ (Donanemab-azbt) UK Approved but Not Reimbursed
On 23 October 2024, Eli Lilly announced that its Kisunla™ (donanemab-azbt) received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as… Read more here.
Dupilumab
25 October 2024 | Sanofi’s Q3/24 Global Dupixent® Sales Reach €3.5 billion
On 25 October 2024, Sanofi announced its Q3 2024 results, including strong growth for Dupixent® (dupilumab) across indications and geographies. Sanofi reports that sales… Read more here.
Nivolumab, Certolizumab
21 October 2024 | Update on Xbrane Out-Licensing Nivolumab & Certolizumab Biosimilars
In August 2024, Xbrane commenced its out-licensing process for Xdivane™, biosimilar to BMS’ Opdivo® (nivolumab), and XB003 (previously known as Xcimzane™, BIIB801)… Read more here.
Pembrolizumab
24 October 2024 | EU | Two New Gynaecological Cancer Indications for MSD’s Keytruda® in Europe
On 24 October 2024, MSD announced that Keytruda® (pembrolizumab) has received marketing approvals from the European Commission for two new gynaecological cancer… Read more here.
Semaglutide
22 October 2024 | US | Novo Nordisk Nominates Semaglutide for Inclusion in FDA’s DDC List
On 22 October 2024, the US Food and Drug Administration (FDA) posted notices detailing Novo Nordisk’s request to include semaglutide in the FDA’s Demonstrable… Read more here.
21 October 2024 | Novo Nordisk Positive Results from Semaglutide Cardiovascular Outcomes Trial
On 21 October 2024, Novo Nordisk announced positive results from the SOUL cardiovascular outcomes trial, which evaluated the impact of Rybelsus® (oral semaglutide)… Read more here.
Ustekinumab
22 October 2024 | US | Alvotech/Teva’s Biosimilar Ustekinumab – Second Presentation FDA Approved
On 22 October 2024, Alvotech and Teva announced US FDA approval of an additional presentation of Selarsdi™ (ustekinumab), biosimilar to Janssen’s Stelara®. The additional… Read more here.
21 October 2024 | AU | Approval Alert: Samsung Bioepis Ustekinumab Biosimilar Approved in Australia
On 21 October 2024, the Australian TGA approved three presentations of Samsung Bioepis’ Epyztek®, biosimilar to Janssen’s Stelara® (ustekinumab): 90 mg/1 mL solution for injection… Read more here.
Company Announcements
23 October 2024 | Samsung Biologics’ Q3/24 Results: Accumulated Revenue at Record High
Samsung Biologics has announced its Q3/2024 financial results, reporting that its accumulated revenue has surpassed KRW 3T for the first time and raising its annual revenue… Read more here.
Biopharma Deals 2024
22 October 2024 | Samsung Biologics’ Record-Breaking Contract Manufacturing Deal Worth USD 1.24B
On 22 October 2024, Samsung Biologics announced that it has entered a contract manufacturing deal worth USD 1.24 billion, with an un-named Asia-based pharmaceutical… 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.
Imogen Bain
Paralegal
Imogen is a paralegal supporting Pearce IP’s legal and trade mark teams. Imogen prepares patent litigation updates, conducts legal research, and provides paralegal and administrative assistance.
Imogen comes from a background working in hospitality, where she has learnt how to be an effective communicator and work efficiently. Imogen has an interest in the design space, having completed her Certificate III in Design Fundamentals. Her knowledge of the design industry has improved her understanding of the IP realm and has strengthened her passion for IP law. Imogen is a highly disciplined and organised individual who works to assist her colleagues with dedication and optimism.