Vericiguat became the first oral soluble guanylate cyclase stimulator to win FDA approval for use in heart failure patients. The drug, branded Verquvo, was developed by Merck & Co. Inc. as part of a $1 billion deal with Bayer AG. But its commercial potential could be hampered by its modest clinical efficacy and increasing competition in the space, as well as difficulties launching a new drug during a pandemic.
Sekar Kathiresan is building Verve Therapeutics Inc. around the concept of a one-and-done treatment for cardiovascular disease because only half of patients are disciplined enough to take a statin every day. “That’s a huge issue for durable cholesterol lowering after a heart attack,” Verve’s CEO and co-founder told BioWorld.
LONDON – A remodeled Rexgenero Ltd. has launched as an integrated cell and gene therapy specialist, following integration of a French biotech acquired last year and a commitment from the company’s two shareholders to invest £40 million (US$54 million).
PERTH, Australia – Australia’s Medical Technologies and Pharmaceuticals Industry Growth Center (MTPConnect) is boosting funding for the translation and commercialization of research in diabetes, cardiovascular disease and regenerative medicine.
HONG KONG – With the sale of a group of noncore assets to a little-known Chinese company, Takeda Pharmaceutical Co. Ltd. took another step in a multibillion-dollar string of divestitures that is part of a plan to cut debt and focus on five key business areas. Takeda announced on Dec. 21 the sale of a portfolio of noncore prescription drugs marketed in China to Hasten Biopharmaceutic Co. Ltd. (China).
DUBLIN – Shares in Pluristem Therapeutics Inc. were down 40% by midday Dec. 9 on news that it was terminating a pivotal phase III trial of its allogeneic, placenta-derived cell therapy, PLX-PAD, in critical limb ischemia (CLI), following a futility analysis, which concluded that the study would be unlikely to meet its primary endpoint.
The FDA has issued Sanofi SA a complete response letter (CRL) regarding its complement pathway inhibitor sutimlimab, citing deficiencies found during a pre-license inspection of a third-party manufacturing facility.
New and updated preclinical and clinical data presented by biopharma firms at the 2020 American Heart Association Scientific Sessions Nov. 13-17, including: Acceleron, Astrazeneca, Cytokinetics, Daiichi, Myokardia, Silence.
Shares in Cytokinetics Inc. closed down 42% Oct. 8 on news that omecamtiv mecarbil, a heart failure drug which it is developing with Amgen Inc. (with funding and strategic support from Les Laboratoires Servier SAS), failed to demonstrate a survival benefit in a large-scale cardiovascular outcomes study.
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