Livanova has obtained clearance from the FDA for its Lifesparc system, a smaller, versatile circulatory support pump and controller that is designed to pump blood through an extracorporeal circuit for less than six-hour periods to provide either temporary circulatory bypass or full or partial cardiopulmonary bypass.
Health Canada has granted SpeeDx approval for its ResistancePlus MG, a molecular diagnostic test kit that is designed to detect sexually transmitted infection Mycoplasma genitalium and genetic mutations linked to antibiotic resistance.
Mavupharma, a developer of cancer therapies using the STimulator on INterferon Genes, or STING, signaling pathway, has been acquired by AbbVie. No financial terms of the deal were disclosed.
The FDA has initiated priority review for Novartis' sickle cell disease candidate crizanlizumab, which the company thinks has blockbuster potential. The anti-P-selectin antibody helps prevent blood cells of SCD patients from sticking together and causing blockages in blood vessels.
Topline data from Synlogic's Phase I/II study assessing its candidate SYNB1618, a Synthetic Biotic medication for patients with phenylketonuria showed the treatment induced a statistically significant rise in the patients' biomarkers for SYB1618 activity. Findings will be presented in September at the annual symposium of the Society for the Study of Inborn Errors of Metabolism.
Novo Nordisk's Esperoct, or turoctocog alfa pegol, a clotting factor VIII indicated for patients of all ages with hemophilia A, has received Health Canada's approval. The endorsement includes use as a preventive treatment, on-demand use to control bleeding episodes and use during surgery for bleeding reduction.
Pakistan's Environmental Protection Agency of Ministry of Climate Change has issued a ban on trials developing biotech corn, as well as all related activities, for an unspecified period to avoid contamination of natural crops. The action also means that biosafety licenses have been suspended for import and field trials of biotech maize in the country.
Biotechnology is already advancing in the cities, but rural America is being left out of the development loop, wrote John Cumbers, founder and CEO of SynBioBeta. Cumbers offers several strategies to develop biotechnology in rural America by creating a Bio-Belt that runs through middle America, coupled with strategic investments and the establishment of national laboratories committed to biological manufacturing.
The California Energy Commission has awarded a $2.8 million grant to Oberon Fuels for a novel pilot project to be completed in phases for the production of renewable dimethyl ether, a product generated from dairy waste, which has the potential to become the most carbon-negative fuel for transportation to be produced at scale.
The NIH's National Institute of Allergy and Infectious Diseases is beginning a late-stage trial of a vaccine for the prevention of HIV. The study will include men and transgender people in Europe, North America and South America, and it will complement an ongoing study of women that began in Africa in 2017.