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 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...
Aug 15, 2024
On 15 August 2024, Alvotech announced its financial results for the first half of 2024, reporting total revenues of US$236 million, a more than 10-fold increase compared to 1H 2023, and product revenues of US$66 million, up 190% from 1H 2023. Its EBITDA was positive...
Aug 15, 2024
Incyte has announced positive results from a pivotal study of tafasitamab (Monjuvi®) in relapsed or refractory follicular lymphoma. Based on these positive results, Incyte expects to file a supplemental Biologics License Application for tafasitamab for the treatment...
Aug 14, 2024
On 14 August 2024, Celltrion received FDA approval for its global phase 3 clinical trial of CT-P55, biosimilar to Novartis’ Cosentyx® (secukinumab). Celltrion reports that global market sales for Cosentyx® reached US $4.98 billion in 2023, and that Novartis’ “material...
Aug 14, 2024
AstraZeneca has announced that its Imfinzi® (durvalumab) and Lynparza® (olaparib) combination has been approved in the EU as treatment for certain patients with primary advanced or recurrent endometrial cancer. This approval follows the recommendation by the EMA’s...
Aug 14, 2024
On 13 August, AstraZeneca announced that the National Medical Products Administration (NMPA) in China has given conditional approval for the use of Enhertu (trastuzumab deruxtecan) as a monotherapy treatment for patients with locally advanced or metastatic...
Aug 13, 2024
A representative from Novo Nordisk has recently announced that the company is planning to submit regulatory approval applications for its insulin icodec and semaglutide combination (IcoSema) in jurisdictions outside the US. The decision to file the applications...
Aug 13, 2024
India’s Medical Dialogues reports that Intas Pharmaceuticals has received the Central Drug Standard Control Organisation’s (CDSCO) approval to conduct a Phase III clinical study to compare the efficacy, safety, immunogenicity and pharmacokinetics of its proposed...
Aug 13, 2024
Formycon has announced its half-year financial results, reporting Group revenue of €26.9 million and a 2024 revenue forecast remaining between €55-€65 million, driven by its biosimilar pipeline and projects. This includes the “strong performance” of FYB201, biosimilar...
Subscribe to our Pearce IP Blogs and BioBlast® to receive our updates via email.