Aflibercept
15 November 2024 | EU | Sandoz Aflibercept Biosimilars EU Approved & Formycon/Klinge Biosims Recommended
On 15 November 2024, Sandoz announced that its Afqlir®, biosimilar to Bayer/Regeneron’s Eylea® (aflibercept), has been approved in Europe for the treatment of nAMD, macular… Read more here.
Daratumumab
8 November 2024 | US | EU | J&J Seeks US and EU Approvals for New Daratumumab Indications
On 8 November 2024, Johnson & Johnson (J&J) announced that it has submitted applications to the US FDA and European Medicines Agency (EMA) for approval of a new indication… Read more here.
Denosumab
14 November 2024 | EU | Positive CHMP Opinions for Samsung Bioepis’ Denosumab Biosimilars
On 14 November 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Samsung Bioepis’ Obodence™… Read more here.
Dupilumab
15 November 2024 | US | FDA Accepts Regeneron/Sanofi’s Dupixent® (Dupilumab) sBLA Resubmission for Chronic Spontaneous Urticaria
On 15 November 2024, Regeneron and Sanofi announced that the US FDA has accepted for review their resubmitted supplemental Biologics Licence Application (sBLA) for Dupixent®… Read more here.
Isatuximab
14 November 2024 | EU | UK | Sanofi’s Sarclisa® (Isatuximab) Recommended for EU Approval; Wins Appeal Against Rejection by UK’s NICE
On 14 November 2024, Sanofi announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion … Read more here.
Lecanemab
14 November 2024 | EU | EU’s CHMP Reverses Position on Eisai’s Lecanemab; Good News for Patients with Early Alzheimer’s Disease
On 14 November 2024, Eisai reported that it has received a positive opinion from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use… Read more here.
Nipocalimab
11 November 2024 | US | FDA Grants Breakthrough Therapy Designation for J&J’s Nipocalimab
On 11 November 2024, Johnson & Johnson (J&J) announced that the US FDA has granted nipocalimab Breakthrough Therapy designation (BTD) for the treatment of adults… Read more here.
Pembrolizumab, Nivolumab, Ipilimumab & More
15 November 2024 | EU | CHMP Green Light for InflaRx’s Gohibic® (Vilobelimab) & Expanded Indications for MSD, BMS, Janssen, Sanofi & Regeneron
At the November 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation… Read more here.
Semaglutide, Liraglutide
13 November 2024 | New Studies Show the Potential of Semaglutide for Treating Alcohol Use Disorder and Knee Pain
GLP-1 agonists (also known as GLP-1 receptor agonists) represent a class of medications used to treat type 2 diabetes mellitus. Well-known examples of drugs in this class include those… Read more here.
Trastuzumab deruxtecan
7 November 2024 | US | Daiichi Sankyo and AstraZeneca Awarded Prix Galien Best Biotechnology Product Award for Enhertu®
On 7 November 2024, the Galien Foundation awarded Daiichi Sankyo and AstraZeneca the Prix Galien USA Award for Best Biotechnology Product in relation to Enhertu®… Read more here.
Company Announcements
13 November 2024 | Alvotech’s Biosimilars Sales Drive 4-Fold Revenue Increase
On 13 November 2024, Alvotech announced its financial results for the first 9 months of 2024, reporting an increase in total revenues of US $300 million and an over four… Read more here.
BioPharma Deals 2024
14 November 2024 | MSD Enters US$3.3B Deal to Develop and Commercialise LaNova’s PD-1/VEGF Bispecific Antibody
On 14 November 2024, Merck (known as MSD outside the US and Canada) announced that it has entered an exclusive global licence agreement with Shanghai-based LaNova… Read more here.
13 November 2024 | BioNTech to Acquire Biotheus and Investigational Bispecific Antibody Targeting PD-L1 and VEGF-A
On 13 November 2024, BioNTech announced that it has entered a definitive agreement to acquire Biotheus together with global rights to Biotheus’ late-stage clinical asset, BNT327… 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.