New regulations tighten regulatory oversight of China’s investigator-initiated trials (IITs) but legitimize the pathway that will be open to other modalities beyond cell and gene therapies.
New regulations tighten regulatory oversight of China’s investigator-initiated trials (IITs) but legitimize the pathway that will be open to other modalities beyond cell and gene therapies.
Regeneron Pharmaceuticals Inc. is entering the radiopharmaceutical space via a collaboration with Telix Pharmaceuticals Ltd. to jointly develop and commercialize next-generation radiopharmaceutical therapies.
Regeneron Pharmaceuticals Inc. is entering the radiopharmaceutical space via a collaboration with Telix Pharmaceuticals Ltd. to jointly develop and commercialize next-generation radiopharmaceutical therapies.
Aktis Oncology Inc. has obtained IND approvals from the FDA enabling the company to proceed to a phase Ib trial with AKY-2519, a miniprotein radioconjugate targeting B7-H3-expressing tumors, including prostate, lung and other solid tumors. Specifically, the IND clearances relate to [64Cu]Cu-AKY-2519 for imaging and [225Ac]Ac-AKY-2519 for therapeutic use.
In a small Houston clinic, more than a decade ago, patients with advanced cancer were receiving treatments that used radioactive molecules to seek out tumors and destroy them from within using an approach that would eventually help reshape oncology.
Astrazeneca plc is investing $15 billion in China through 2030 to expand R&D and manufacturing, marking one of the largest long-term investments by a multinational pharma company in the country. The U.K.-based company also struck a deal worth up to $3.5 billion with China’s CSPC Pharmaceuticals Group Ltd. to accelerate the development of next-generation therapies for obesity and type 2 diabetes.
Astrazeneca plc is investing $15 billion in China through 2030 to expand R&D and manufacturing, marking one of the largest long-term investments by a multinational pharma company in the country. The U.K.-based company also struck a deal worth up to $3.5 billion with China’s CSPC Pharmaceuticals Group Ltd. to accelerate the development of next-generation therapies for obesity and type 2 diabetes.
China’s National Medical Products Administration has accepted for review Grand Pharmaceutical Group Ltd./Telix Pharmaceuticals Ltd.’s NDA for TLX-591-CDx (Illuccix, gallium Ga 68 PSMA-11), a radionuclide-drug conjugate for diagnosing prostate cancer.
Radiopharma-focused Aktis Oncology Inc. priced its recently upsized IPO, selling 17.65 million shares at $18 apiece, the high end of its pricing range, raising gross proceeds of $318 million, a hopeful sign that 2026 might signal an opening of the IPO window for biopharma.
