Aflibercept
19 September 2024 | EU | Sandoz & Samsung Bioepis/Biogen Aflibercept Biosimilars Recommended in Europe
At its September meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Sandoz’s and Samsung Bioepis/Biogen’s biosimilars to Regeneron’s Eylea® (aflibercept)… Read more here.
Amivantamab
19 September 2024 | US | New Indication Alert: J&J’s Rybrevant® Combination US-Approved for NSCLC
On 19 September 2024, Johnson & Johnson (J&J) announced that it received FDA approval for Rybrevant® (amivantamab-vmjw) in combination with standard of care chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients… Read more here.
Belantamab mafodotin
17 September 2024 | JP | GSK’s NDA for Blenrep® Combinations Accepted in Japan
On 17 September 2024, GlaxoSmithKline (GSK) announced that Japan’s Ministry of Health has accepted for review a new drug application for Blenrep® (belantamab mafodotin) in combination with BorDex (bortezomib plus dexamethasone)… Read more here.
Benralizumab
18 September 2024 | US | New Indication Alert: AstraZeneca’s Fasenra® FDA-Approved for EGPA
On 18 September 2024, AstraZeneca announced that its Fasenra® (benralizumab) has been approved by the FDA for eosinophilic granulomatosis with polyangiitis (EGPA). The approval was based on positive results from a Phase 3 trial (MANDARA)… Read more here.
Dupilumab
12 September 2024 | UK | New Indication Alert: Sanofi and Regeneron’s Dupixent® Approved in UK for COPD
On 12 September 2024, PM Live reported that Sanofi and Regeneron’s Dupixent® (dupilumab) has been approved by the UK Medicines Healthcare products Regulatory Agency (MHRA) as an add-on maintenance treatment… Read more here.
Lebrikizumab
13 September 2024 | US | Approval Alert: FDA Approves Eli Lilly’s Ebglyss® for Eczema
On 13 September 2024, Eli Lilly announced that its Ebglyss® (lebrikizumab-lbkz) received FDA approval for adults and children 12 years and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled… Read more here.
Marstacimab | Serplulimab
19 September 2024 | EU | CHMP Positive Opinions for 3 New Biologics and Extended Indications for 5 in EU
At its September 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three new biologics, each of which was designated as an orphan medicine during development… Read more here.
Patritumab deruxtecan
17 September 2024 | Daiichi/MSD Ph 3 Trial Shows Patritumab Deruxtecan Improves Progression-Free Survival in NSCLC
On 17 September 2024, Daiichi Sankyo and MSD announced positive results from a Phase 3 trial of their antibody drug conjugate, patritumab deruxtecan (HER3-DXd). In the trial (HERTENA-Lung02), patritumab deruxtecan showed… Read more here.
Pembrolizumab
18 September 2024 | US | New Indication Alert: MSD’s Keytruda® Plus Chemo FDA-Approved for MPM
On 18 September 2024, Merck (known as MSD outside the US and Canada) announced that Keytruda® (pembrolizumab) has been approved by the FDA, in combination with pemetrexed and platinum chemotherapy… Read more here.
Semaglutide
19 September 2024 | EU | EMA’s CHMP Recommends Expanded Wegovy® Label for Obesity-Related HFpEF
On 19 September 2024, Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for a label expansion for Novo Nordisk’s Wegovy® (semaglutide 2.4mg)… Read more here.
10 September 2024 | Iconovo Commences Development of Intranasal Semaglutide
On 10 September 2024, Swedish CDMO, Iconovo, announced that it has commenced developing an intranasally inhaled form of semaglutide for treatment of obesity. The product will reportedly use an improved form… Read more here.
Trastuzumab
18 September 2024 | US | Accord BioPharma Receives FDA Approval for Second Strength of its Biosimilar Trastuzumab
On 18 September 2024, Accord BioPharma announced that the FDA has approved a 420mg strength of its Hercessi™ (trastuzumab-strf), biosimilar to Roche’s Herceptin®, for HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma… Read more here.
Ustekinumab
17 September 2024 | Formycon to Present Clinical Data on FYB202 (Ustekinumab) Later This Month
Formycon has announced that it will present study data for Fymskina (FYB202), biosimilar to Janssen’s Stelara® (ustekinumab), at the 2024 European Academy of Dermatology and Venerology Congress (25 to 28 September in Amsterdam)… 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.