Category: Regulations
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Exec. Order Aims to Boost U.S. Biotech, Manufacturing
An executive order issued by President Joe Biden yesterday seeks to make biotechnology and biomanufacturing a centerpiece of the American economy.
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Infographic – U.S. Drug Prices vs. Other Countries
Rand Corporation published a study comparing U.S. drug prices to 32 other countries, and found U.S. residents pay on average 190 percent of the price paid elsewhere in the world.
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Trial Okayed for Engineered Cell Cancer Therapy
A clinical trial is set to begin testing engineered immune-system cells designed to precisely target and infiltrate cancerous tumors without other potentially toxic proteins.
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FDA Issues Action Plan for Rare Neuro Diseases
The Food and Drug Administration published its blueprint to encourage new treatments for rare neurodegenerative disorders, including ALS.
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Trial Set for Gut Infection Biologic Treatment
A developer of biologic therapies for gastrointestinal disorders says FDA cleared its request for a clinical trial testing its treatment for C. difficile.
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Trial Set for Respiratory Disease Nasal Spray Vaccine
A clinical trial is about to begin enrolling participants to test a vaccine given as a nasal spray protecting against respiratory syncytial virus, or RSV.
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Precision Meds Continue Gaining FDA Approvals
Food and Drug Administration approved 17 new medications in 2021 addressing genetic targets, according to data from a precision medicine advocacy group.
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FDA Issues Guidance for Non-Opioid Acute Pain Relief
The Food and Drug Administration released for comment review processes for new non-opioid drugs to relieve acute or temporary pain episodes.
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India Authorizes Covid-19 Vaccines Designed in US
The government of India granted emergency clearance to two vaccines to prevent Covid-19 disease, both designed in U.S. research labs.
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FDA Clears Rapid At-Home Covid-19 Test
The Food and Drug Administration granted an emergency authorization to a quick diagnostic test for SARS-CoV-2 viruses, conducted at home.