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US Govt to Buy 1.25M Regeneron Covid-19 Therapies

SARS-Cov-2 virus

The U.S. Department of Health and Human Services is buying up to 1.25 million more doses of Regeneron’s Covid-19 antibody therapy, for $2.63 billion. . . . → Read More: US Govt to Buy 1.25M Regeneron Covid-19 Therapies

Vaccine Shown Active Against New Covid-19 Variants

mRNA vaccine graphic

A current Covid-19 vaccine is shown in lab tests to produce antibodies that appear to protect against new mutations found in South Africa and the U.K. . . . → Read More: Vaccine Shown Active Against New Covid-19 Variants

FDA Issues Precision Genomic Drug Guidance

DNA analysis graphic

The U.S. Food and Drug Administration issued draft administrative and procedural guidelines for genetic disorders treated with precise gene therapies. . . . → Read More: FDA Issues Precision Genomic Drug Guidance

Trial OKed for Rare Disease Gene Therapy

Nerve cells illustration

A start-up biotech company says it received clearance from the Food and Drug Administration to begin a clinical trial of its gene therapy for Krabbe disease. . . . → Read More: Trial OKed for Rare Disease Gene Therapy

Neuro Device Shown to Relieve Adolescent Migraine Pain

Nervivo device and app

Findings from a clinical trial show a wearable device sending electronic signals into the nervous system relieves migraine pain in children age 12 to 17. . . . → Read More: Neuro Device Shown to Relieve Adolescent Migraine Pain

Covid-19 Antibody Developer Raises $483M in IPO

Wall Street sign

A biotechnology company developing therapeutic antibodies for Covid-19 infections is raising $483 million in its initial public offering of common stock. . . . → Read More: Covid-19 Antibody Developer Raises $483M in IPO

FDA Begins Qualifying Non-Animal Testing Options

Lab mouse

The Food and Drug Administration began a pilot program for assessing alternative technologies to test drugs, biologics, and devices without animals. . . . → Read More: FDA Begins Qualifying Non-Animal Testing Options

Univ, Industry Labs Study Inhaled Covid-19 Antibodies

Adeno-associated virus

Researchers at University of Pennsylvania and Regeneron are studying delivery of synthetic antibodies directly to the nose to prevent Covid-19 infections. . . . → Read More: Univ, Industry Labs Study Inhaled Covid-19 Antibodies

Trial Requested for Covid-19 Vaccine Nasal Spray

Nasal spray

Makers of a Covid-19 vaccine given as a nasal spray asked the Food and Drug Administration to authorize a a human clinical trial of the vaccine. . . . → Read More: Trial Requested for Covid-19 Vaccine Nasal Spray

Stem Cell Respiratory Therapy Licensed in $1.4B Deal

Inspecting lung X-rays

Global drug maker Novartis is acquiring a stem cell-based treatment for a serious respiratory disease associated with Covid-19 infections. . . . → Read More: Stem Cell Respiratory Therapy Licensed in $1.4B Deal