Along with Enhertu, Astrazeneca plc now has another breast cancer treatment in its portfolio and it may also become a blockbuster. Truqap (capivasertib), combined with the company’s Faslodex (fulvestrant), is now U.S. FDA-approved for treating hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. Read More
Low expectations on Wall Street for the Pulmonary-Allergy Drugs Advisory Committee (PADAC) sit-down on Merck & Co. Inc.’s P2X3 receptor antagonist gefapixant for chronic cough (CC) translated to negative balloting by panelists. PADAC members were polled on a single question: Does the evidence demonstrate that [Merck’s] gefapixant provides a clinically meaningful benefit to adults with refractory or unexplained CC? The results came out 12 no, 1 yes. Read More
The U.S. FTC’s policing of Orange Book patent listings begs the question of when, and whether, the FDA will deliver on its commitment to provide more clarity on the types of device patents that can be listed as covering a “drug product.” Read More
Newco T-Therapeutics Ltd. has raised £48 million (US$59 million) in a series A to advance development of T-cell receptors generated by its transgenic mouse platform for the treatment of solid tumors, autoimmune diseases and infections. Read More
In efforts to strengthen cooperation between the U.S. and South Korea’s life sciences sector, industry organizations like Biocom California and KoreaBIO are helping foster cross-border collaboration as Korea looks to ramp up the so-called Bio Economy 2.0. KoreaBIO, which stands for the Korea Biotechnology Industry Organization, in its latest feat welcomed a trade delegation run by the San Diego Regional Economic Development Corp. and the World Trade Center San Diego in November 2023, helping bolster cooperation between companies in Korea and in the San Diego and Tijuana, Mexico, regions. Read More
The U.S. and China biotech Apollomics Inc. on Nov. 16 gained the NMPA’s conditional approval for its cellular mesenchymal-epithelial transcription inhibitor for lung cancer called vebreltinib (APL-1010) through its Beijing-based partner, Avistone Biotechnology Co. Ltd. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alentis, Certa, Dermata, Ensysce, Minoryx, Sringworks, TB Alliance and Visen. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 2518542 Alberta, ABVC, Aibtl, Alberta, Alkermes, Arecor, Auris, Avonlea Drewry, Axxam, Eli Lilly, Emergex, Khiron, Momentum, Mural, Point, Zerenia. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Appolomics, Ardelyx, Argenx, Bristol Myers, Chemomab, Crispr, Epic Bio, Halozyme, Praxis, Lighthouse, Palmella, Versameb, Vertex. Read More
