Avita Medical Ltd.’s Recell system won FDA breakthrough device designations in soft tissue repair and vitiligo. Melbourne-headquartered Avita, a regenerative medicine company developed the Recell system, a technology platform that enables point-of-care autologous skin restoration.
Election day has come and gone in the U.S., but the question of which party will control Congress remains unanswered, signaling that the country is as divided as ever politically and ideologically. While Democrats and Republicans may agree on problems in the life sciences sector, they often disagree on how to address them.
Veru Pharmaceuticals Inc.’s COVID-19 therapy VERU-111 (sabizabulin) failed to win full support from the U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee, which was asked to decide about endorsing the firm’s request for an emergency use authorization to market the drug.
Shares in Clovis Oncology Inc. (NASDAQ:CLVS) tumbled more than 71% after it warned it is facing bankruptcy with barely enough cash left to last until the end of 2022, debts of more than $3 billion, and dwindling revenues from its only approved cancer drug, Rubraca (rucaparib).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aleta, Biomarin, Blue Earth, Immunomic, Merck, Omeros, Oncotelic.
Europe is losing its innovative edge in biopharma, especially when it comes to advanced therapy medicinal products, including tissue, gene and cell therapies used to prevent, treat and cure rare conditions and some cancers.
Luye Pharma Group has received marketing approval from China’s NMPA for the triple monoamine reuptake inhibitor Ruoxinlin (toludesvenlafaxine hydrochloride) to treat patients with major depressive disorder, a condition that “has become one of the most prevalent mental disorders in China, causing a heavy burden on patients, their families and the entire society,” said Luye President Yang Rongbing.
Briefing documents related to the Nov. 9 meeting of the U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee augur well for Veru Pharmaceuticals Inc.’s request for an emergency use authorization to market VERU-111 (sabizabulin) as a treatment for COVID-19.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: CTL Amedica, Procisedx.
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