Benralizumab
28 October 2024 | EU | New Indication Alert: AstraZeneca’s Fasenra® (Benralizumab) EU-Approved for EGPA
On 28 October 2024, AstraZeneca announced that the European Commission has approved its Fasenra® (benralizumab) as an add-on treatment for adult patients with relapsing… Read more here.
Denosumab
31 October 2024 | NZ | NZ’s Pharmac Proposes Increased Reimbursement Regime for Amgen’s Denosumab
On 31 October 2024, New Zealand’s drug funding body, Pharmac, announced that it is seeking feedback on a proposal to broaden the reimbursement for Amgen’s denosumab… Read more here.
30 October 2024 | US | FDA Accepts Organon/Shanghai Henlius’ BLA for Biosimilar Denosumab
Organon and Shanghai Henlius Biotech announced on 30 October 2024 that the FDA accepted their BLA for HLX14, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab)… Read more here.
Elranatamab
29 October 2024 | UK | NICE recommends Pfizer’s Elrexfio® (Elranatamab) for NHS Cancer Drugs Fund
On 29 October 2024, UK’s National Institute for Health and Care Excellence (NICE) recommended Pfizer’s Elrexfio® (elranatamab) for use in the NHS’ Cancer Drugs Fund… Read more here.
Guselkumab
28 October 2024 | Positive Ph 3 Results for J&J’s Tremfya® (Guselkumab) in Crohn’s Disease and Plaque Psoriasis
On 28 October 2024, Johnson & Johnson (J&J) announced that its Phase 3 GRAVITI study of Tremfya® (guselkumab) in moderately to severely active Crohn’s disease showed “robust”… Read more here.
Infliximab
30 October 2024 | Celltrion’s Positive Results in Study Comparing Infliximab SC Monotherapy and Immunosuppressant Combination Therapy
On 30 October 2024, Celltrion announced results of a global phase 3, 2-year follow-up study comparing infliximab SC (CT-P13, Zymfentra™) as monotherapy and in… Read more here.
Lebrikizumab
25 October 2024 | Positive Results for Eli Lilly’s Ebglyss™ (Lebrikizumab-lbkz)
On 25 October 2024, Eli Lilly announced results from the Phase 3b ADapt study demonstrating that Ebglyss™ (lebrikizumab-lbkz) improved skin (including hand and face) and itch… Read more here.
Lecanemab
31 October 2024 | US | Eisai Completes Fast-Tracked BLA for Leqembi® (Lecanemab-irmb) Maintenance Dose Autoinjector
Following the FDA granting Fast Track designation, Eisai reports that it has completed its rolling submission of a Biologics License Application (BLA) to the FDA for Leqembi®… Read more here.
Liraglutide, Semaglutide, Nivolumab & More – TGA Update
4 November 2024 | AU | Blockbuster Copies and Expansions Ahead in AU – Saxenda®, Opdivo®, Ozempic® & More
Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for the months of August, September and October… Read more here.
Pembrolizumab
31 October 2024 | MSD’s Keytruda® Sales for Q3/24 Reach US $7.4B
On 31 October 2024, Merck, known as MSD outside the US and Canada, published its Q3 2024 financial results, including 17% growth (21% excluding foreign exchange impact)… Read more here.
Semaglutide
1 November 2024 | Novo Nordisk Set to Expand Use of Semaglutide to Liver Health
On 1 November 2024, Novo Nordisk announced positive results from part 1 of a pivotal phase 3 study evaluating the effects of once-weekly semaglutide 2.4 mg in adults with… Read more here.
30 October 2024 | US | Novo Nordisk’s Wegovy® and Ozempic® US Supply Crisis Over
On 30 October 2024, the US Food and Drug Administration (FDA) provided an update on its drug shortage database, reporting that all doses of Novo Nordisk’s popular weight loss… Read more here.
Company Announcements
30 October 2024 | Sandoz’s Q3/9M Results: Strong Biosimilars Growth of 37%/32%
On 30 October 2024, Sandoz announced its Q3 and 9-month 2024 financial results, reporting third quarter net sales of USD 2.6 billion, up 12% in constant currencies, year-on-year… 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.