Preparing to deliver next-generation therapeutics

Mayo Clinic is among the academic medical centers on the cusp of biomanufacturing next-generation cell and gene therapies that offer hope of new cures for rare and complex diseases. Biomanufacturing this new era of biologic medicines is much different than manufacturing pharmaceuticals from complex molecules. It requires highly specialized lab infrastructure, new processes and new scientific know-how.

A couple of Mayo Clinic-led papers encompass some of the first studies to probe how hospital facilities are handling the growing demand for cell and gene therapies that are being tested in clinical trials.Continue reading

Aqualung Therapeutics Corp., an Immunotherapeutics Biotech Company, Closes a $2.5M Convertible Note Raise With a Committed Series A Lead Investor

TUCSON, AZ / ACCESSWIRE / January 18, 2022 / Aqualung Therapeutics, an early stage immunotherapeutics company with an anti-inflammatory therapeutic platform for life-threatening unchecked inflammation, has closed a $2.5M convertible note fund raise led by a $1.5M investment from JSR Life Sciences, LLC. The convertible note close brings the total Aqualung funding to date to >$17M, with $14 million derived from non-dilutive capital via NIH-funded grants and an earlier successfully executed $700,000 early seed round. In addition to investments in the convertible note, JSR Life Sciences has committed an additional $1.5M to the upcoming $10M Series A capital raise.Continue reading

Two Arizona Proposals Win Phase 1 Awards in the HHS Hypertension Innovator Award Competition.  

The U.S. Department of Health and Human Services (HHS) Office on Women’s Health announced the 20 winners of Phase I of the HHS Hypertension Innovator Award Competition.  The competition was created to identify effective, pre-existing programs that care for people with hypertension where the programs could be or are already applied to women with hypertension who are pregnant and/or postpartum. The goal of the competition is to demonstrate sustainability and the ability to replicate and/or expand programs that provide effective monitoring and follow-up of hypertension for women who are pregnant and/or postpartum.

Congratulations go to Emagine Solutions Technology and Valleywise (in collaboration with Creighton University).Continue reading

Opportunity Alert: Arizona Biomedical Research Centre Research Grants

The Arizona Biomedical Research Centre is soliciting applications from eligible entities to fill the FY2022 Research Grant Cohort. Letters of Intent for New Investigator Awards (NIA) or Investigator Grants (IG) will be accepted starting Wednesday, January 5, 2022 through 3:00 p.m. MST, January 19, 2022. Instructions and application materials can be found at https://portal.ecivis.com. The solicitation number is RFGA2022-010.Continue reading

FDA approves Novartis Leqvio® (inclisiran), first-in-class siRNA to lower cholesterol and keep it low with two doses a year

For over 50 years, Novartis has developed innovative medicines to treat cardiovascular disease. Building on this legacy, I am reaching out to share the news that Novartis received approval from the U.S. Food and Drug Administration (FDA) for Leqvio® (inclisiran), the first and only small interfering RNA (siRNA) to provide effective and sustained reduction in low-density lipid cholesterol (LDL-C), commonly referred to as “bad cholesterol,” as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of LDL-C. The effect of Leqvio on cardiovascular morbidity and mortality has not yet been determined but is being explored in clinical trials currently underway.

The United States spends over $125 billion on direct medical expenses for ASCVD care each year, and heart disease and stroke represent the largest medical expenditures in the country. Beyond direct healthcare costs, heart disease and stroke have been estimated to result in $138 billion annually in lost productivity.

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