Australia is poised to play a leading role in the rise of the global radiopharmaceutical industry, as advanced therapies drive significant investment and rapid expansion, according to a new discussion paper from industry accelerator Mtpconnect.
Novartis AG is bolstering its radioligand arsenal with the takeout of Mariana Oncology Inc. for $1 billion up front and as much as $750 million in potential milestone payments. Watertown, Mass.-based Mariana has developed peptide-based radiopharmaceuticals targeting solid tumors. The company’s lead program, MC-339, is a radioligand approach to small-cell lung cancer, due to enter the clinic later this year.
Just a few days after the U.S. Congressional Research Service issued a report suggesting ways Congress could resolve the unanswered questions about patent listings in the FDA’s Orange Book, the FTC sent a second round of warning letters to eight biopharma companies and their subsidiaries, citing the listing of device patents for combination products.
Novartis Pharma AG continues to build up its radiopharmaceutical powerhouse and has expanded a peptide discovery collaboration with Peptidream Inc. in a deal worth up to $2.71 billion. Under the multi-program agreement, Kawasaki, Japan-based Peptidream will use its peptide discovery platform system technology to identify and optimize novel macrocyclic peptides against targets selected by Novartis for potential conjugation to radioligand therapies or other applications for both therapeutic and diagnostic purposes.
The U.S. government chalked up another win April 29 against the constitutional challenges to the Inflation Reduction Act’s provision mandating direct Medicare price negotiations for selected prescription drugs.
The U.S. FDA issued a revised draft guidance, “Promotional labeling and advertising considerations for prescription biological reference and biosimilar products,” to help ensure promotional communications involving reference biologics or their follow-ons are accurate, truthful and not misleading.
As Novartis AG’s approved prostate cancer therapy, Pluvicto (177Lu-PSMA-617), continues on a growth trajectory, the firm signed a licensing deal with Arvinas Inc. potentially valued at north of $1 billion for global development and commercialization of ARV-766, the latter’s second-generation proteolysis targeting chimera (PROTAC) androgen receptor degrader targeting the same disease.
Biosimilar competition to Amgen Inc.’s denosumab (Prolia/Xgeva) is rising globally, with Mabwell (Shanghai) Bioscience Co. Ltd. gaining the latest China NMPA approval of Maiweijian (TK-006) on April 8. Mabwell’s wholly owned subsidiary, Jiangsu T-mab Biopharma Co. Ltd., gained NMPA clearance of Maiweijian (120 mg) as the first denosumab biosimilar for the indications of U.S.-licensed Xgeva for bone-related diseases.
With nine months to go before their introduction, the industry is flagging many uncertainties around the proposed guidelines for implementing joint clinical assessments.
Voydeya (danicopan), from Alexion, Astrazeneca Rare Disease, racked up its second global approval as the U.S. FDA greenlit it as an add-on therapy for treating extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria (PNH), a crowded market with several already approved treatments and more in development.
