No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
Aug 22, 2024
On 22 August 2024, Eisai and Biogen announced that Leqembi® (lecanemab) has received marketing authorisation from the UK’s MHRA for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease. The UK is the first country in Europe to...
Aug 21, 2024
The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s (BMS) supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) and Yervoy® (ipilimumab) as a potential first-line treatment for adult patients with unresectable...
Aug 20, 2024
On 20 August 2024, the FTC and US Biosimilars Council lent their support to the FDA’s position that data from a switching study or studies may no longer be necessary to support licensure of interchangeable biosimilar medicines. In draft guidance published by the FDA...
Aug 19, 2024
On 19 August 2024, AbbVie announced that the European Commission (EC) has granted conditional marketing authorisation for its Tepkinly® (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more...
Aug 19, 2024
On 19 August, Daiichi Sankyo announced that the European Medicines Agency (EMA) has validated a Type II Variation Application for the use of Enhertu® (trastuzumab deruxtecan) as a form of monotherapy treatment for individuals with unresectable or metastatic HER2 low...
Aug 19, 2024
A number of biopharmaceuticals and biosimilars are potentially in line for September listings on Australia’s Pharmaceutical Benefits Scheme (PBS). UCB’s Bimzelx® (bimekizumab) has progressed to the last stage before PBS listing for psoriatic arthritis and ankylosing...
Aug 19, 2024
On 19 August 2024, Taiwanese-based GlycoNex announced that SPD8, biosimilar to Amgen’s Prolia® (denosumab), is expected to enter a Phase 3 clinical trial in Q4 2024. The trial will assess the efficacy, safety and immunogenicity of SPD8 in patients with osteoporosis....
Aug 19, 2024
Celltrion announced on 19 August 2024 that the FDA has approved a phase 3 clinical trial of Zymfentra™ (CT-P13 SC, infliximab SC) for rheumatoid arthritis (RA). In October 2023, Zymfentra™ was the first subcutaneous formulation of infliximab approved by the FDA, for...
Aug 16, 2024
On 16 August 2024, Janssen Biotech, Inc and Janssen-Cilag Pty Ltd commenced patent infringement proceedings against Samsung Bioepis AU Pty Ltd in the Federal Court of Australia. The proceeding is yet to be listed for a first case management hearing. This is the second...
Aug 16, 2024
On 16 August 2024, Bio-Thera announced that it has entered into a licensing and supply agreement with Pharmapark for BAT2306, biosimilar to Cosentyx® (secukinumab). Under the agreement, Pharmapark will have exclusive rights to distribute and market BAT2306 in Russia...
Aug 16, 2024
On 16 August 2024, AstraZeneca announced that the FDA has approved its Imfinzi® (durvalumab), in combination with chemotherapy, for resectable early stage non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor mutations or anaplastic lymphoma...
Aug 15, 2024
On 15 August 2024, Alvotech and Advanz Pharma announced that European Medicines Agency (EMA) has accepted a Marketing Authorisation Application (MAA) for Alvotech-developed AVT06, biosimilar to Regeneron’s Eylea® (aflibercept). The companies expect EMA marketing...
Subscribe to our Pearce IP Blogs and BioBlast® to receive our updates via email.