As South Korea awaits potential changes to drug pricing policies for generics and novel ultra-expensive therapies like Novartis AG’s Kymriah (tisagenclecleucel), the domestic pharmaceutical industry is proactively voicing concerns about some policies that could do more harm than good.
In a global first, Japan's Ministry of Health, Labor and Welfare has approved CSL Ltd.’s and Arcturus Therapeutics Inc.’s self-amplifying messenger RNA (sa-mRNA) vaccine (ARCT-154) for COVID-19 in adults. The approval marks the first milestone for a November 2022 licensing deal under which CSL subsidiary CSL Seqirus in-licensed Arcturus’ late-stage sa-mRNA vaccine platform technology.
Redhill Biopharma Ltd.’s stock (NASDAQ:RDHL) has soared in recent days following news that the U.S. FDA granted five years of market exclusivity for Talicia, a first-line therapy for eradication of Helicobacter pylori infection, which affects about 35% of the U.S. adult population.
Shanghai Henlius Biotech Inc. has announced IND approval by the FDA for HLX-42 for injection, an antibody-drug conjugate (ADC) developed under a collaboration between Henlius and Medilink Therapeutics.
Polaris Pharmaceuticals Inc. has submitted the first part of its rolling BLA to the FDA for lead product, ADI-PEG 20, for systemic treatment of patients with malignant pleural mesothelioma with non-epithelioid histology in combination with a platinum agent and pemetrexed. The BLA is supported by the pivotal phase III Atomic study in which pegargiminase (pegylated arginine deiminase/ADI-PEG 20) met the primary endpoint of a statistically significant improvement in overall survival and the secondary endpoint of a significant improvement in progression-free survival in patients with malignant pleural mesothelioma.
The U.S. FDA’s Office of Prescription Drug Promotion is calling out Otsuka Pharmaceutical Co. Ltd. for making “false or misleading claims and representations about the efficacy of Rexulti” in a television advertisement.
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.
With the U.S. FDA giving the green light to Takeda Pharmaceutical Co. Ltd.’s Adzynma for treating a rare blood clotting disorder caused by a deficiency in the ADAMTS13 enzyme, the company has won two approvals in two days after the FDA approved fruquintinib a day earlier.
The America Invents Act of 2011 was designed to provide a durable overhaul of the U.S. patent system, but the inter partes review process has drawn fire from inventors as a patent-killing machine.
The U.S. FDA approved Takeda Pharmaceutical Co. Ltd.’s Fruzaqla (fruquintinib) nearly 20 days ahead of its Nov. 30 PDUFA date for adults with previously treated metastatic colorectal cancer. “Fruzaqla is the first targeted therapy approved in the U.S. for mCRC regardless of biomarker status or prior types of therapies in more than a decade,” Stefanie Granado, head of Takeda’s U.S. Oncology business unit, told BioWorld.
RSS
