The company reported positive efficacy results, but also revealed allegations that an investigator had failed to adhere to trial protocol and was alleged to have fabricated emails to cover their tracks.
Execs at BioXcel Therapeutics, Inc. were bullish on data from the Phase III TRANQUILITY II study of Igalmi (dexmedetomidine) in Alzheimer’s disease-related agitation, but problems at a trial site that enrolled a large percentage of the study’s participants cast a shadow over the announcement, and the company may have a difficult time getting out from under it.
BioXcel announced 29 June results from the trial of Igalmi, also known as BXCL501, showing that the study met its...
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.
To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.
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.
![Spotlight On RDCs, AOCs As Leading Novel Bioconjugates[Updated]](https://web.insights.norstella-labs.com/resizer/v2/3M7ZAWZOBNK7NG4A4WDOIFG6DU.jpg?smart=true&auth=392a1fdb3cfacb29445720c412410e598dbcc5f90f14857652cd498bd0faa0fb&width=400&height=225)