AstraZeneca has released positive top-line data from a new Phase III study of the LAMA/LABA combination, Duaklir, in COPD that could lead to a US NDA filing in 2018, and the start of US marketing by partner Circassia.
Circassia Pharmaceuticals PLC’s plans to build up its respiratory franchise in the US appear to be on track, with its partner AstraZeneca PLC reporting positive top-line data from the Phase III AMPLIFY study of Duaklir (aclidinium bromide and formoterol fumarate 400 µg/12 µg twice daily) inhaler in patients with moderate to severe stable chronic obstructive pulmonary disease (COPD).
The UK biotech says it is looking forward to AstraZeneca filing a US NDA for Duaklir in the coming months...
Chinese firm Sciwind has revealed additional Phase III findings for its promising once-weekly GLP-1 agonist ecnoglutide, just one asset in a burgeoning Chinese sector that could see the emergence of new rivals to current global leaders in obesity and diabetes.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
The article discusses the impact of upcoming patent expirations in oncology biologics on biosimilar developers, highlighting the opportunities in Antibody-Drug Conjugates (ADCs) and Bispecific Antibodies (BsAbs). It explores the challenges posed by the structural complexities of these biologics, necessitating new bioanalytical tools and manufacturing processes. The evolving regulatory landscape, with contributions from EMA, FDA, and WHO, offers flexible pathways but also presents challenges. The article underscores the potential for biosimilars to generate significant cost savings and enhance patient access to cancer treatments over the next decade.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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