China’s National Medical Products Administration has given the thumbs up to Junshi Biosciences Co. Ltd.’s NDA for ongericimab, a recombinant humanized anti-PCSK9 monoclonal antibody, marking the third PCSK9 inhibitor to be cleared in China.
“This was worse than our national election,” Eric Peterson said as he explained his vote Oct. 10 concluding that Stealth Biotherapeutics Inc.’s elamipretide is effective in treating Barth syndrome, an ultra-rare mitochondrial disease that currently affects 129 males in the U.S. Peterson, a vice provost, senior associate dean and professor at the University of Texas Southwestern Medical Center, was one of 10 members of the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) who came to that conclusion. Six others had a different opinion. Regardless of which way they voted, the panelists attested to how difficult the decision was.
Clinical research has shown that patients with systemic lupus erythematosus (SLE) are more likely to develop cardiovascular disease (CVD), including cardiac and vascular dysfunction. In the current study, researchers from Medical University of South Carolina developed and characterized a novel preclinical model of SLE-like CVD.
Rhythm AI Ltd recently became the latest company to receive U.S. FDA clearance for its artificial intelligenc-based software for optimizing Atrial Fibrillation procedures.
The U.S. FDA gave the 510(k) green light to Echo IQ Ltd.’s Echosolv AS for its AI-enabled software as a medical device to be used as a decision support aid in detecting severe aortic stenosis.
Stealth Biotherapeutics Inc. had hoped the U.S. FDA would have approved its lead candidate, elamipretide, as the first treatment for Barth syndrome by now. Instead, it’s headed to a meet-up with the agency’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) Oct. 10. The discussion and vote at that meeting could be make-or-break for patients with the ultra-rare debilitating mitochondrial disease that has no approved therapies. “Barring support from CRDAC, the future of elamipretide for Barth syndrome in the U.S. is tenuous," Stealth CEO Reenie McCarthy told BioWorld.
Astrazeneca plc is adding a preclinical-stage candidate to its cardiovascular pipeline via a potentially $2 billion licensing agreement with CSPC Pharmaceutical Group Ltd., which includes a $100 million up-front payment for rights to YS-2302018, an oral Lp(a) disruptor. It’s an impressive figure for such an early program, but the Cambridge, U.K.-based pharma hailed the small molecule’s potential against a range of indications, both alone and in combination regimens that could include PCSK9 inhibitor AZD-0780.
CSPC Pharmaceutical Group Ltd. has entered into an exclusive license agreement with Astrazeneca plc for the global development, manufacture and commercialization of CSPC’s lipoprotein(a) (Lp[a]) inhibitor, YS-2302018, and any pharmaceutical or biological product subsequently developed that includes the compound.
Astrazeneca plc is adding a preclinical-stage candidate to its cardiovascular pipeline via a potentially $2 billion licensing agreement with CSPC Pharmaceutical Group Ltd., which includes a $100 million up-front payment for rights to YS-2302018, an oral Lp(a) disruptor. It’s an impressive figure for such an early program, but the Cambridge, U.K.-based pharma hailed the small molecule’s potential against a range of indications, both alone and in combination regimens that could include PCSK9 inhibitor AZD-0780.
Danish pharma giant Novo Nordisk A/S is set to launch its blockbuster glucagon-like peptide-1 therapy, Wegovy (semaglutide), in South Korea’s growing obesity therapeutics market next week, a company official confirmed to BioWorld.
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