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FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain

FDA Law Blog: Biosimilars

After its enactment in 2003, successive administrations thwarted its implementation by declining to certify to Congress that importation will pose no additional risk to public health and safety and will result in a significant reduction in cost to American consumers, as the statute requires. This must be a U.S.-based

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Gamma delta T cells: a rising star in cancer therapy

Drug Target Review

from 2003 to 2006, covering the biotechnology and life-science tools sectors. Normality sensing licenses local T cells for innate-like tissue surveillance. J Exp Med 198(5):747-755 (2003). Kabelitz D, Serrano R, Kouakanou L, et al. Cancer immunotherapy with γδ T cells: many paths ahead of us. Cell Mol Immunol 17:925-939 (2020).

Therapies 104
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Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications

The Pharma Data

Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection across all approved U.S. with Xolair since its initial approval in 2003. today announced that the U.S. indications.

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BioArctic receives European patent for new antibodies targeting Alzheimer’s disease

The Pharma Data

The company was founded in 2003 based on innovative research from Uppsala University , Sweden. The project portfolio is a combination of fully funded projects run in partnership with global pharmaceutical companies and innovative in-house projects with significant market and out-licensing potential.

Disease 40
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Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir

The Pharma Data

Since licensed by Ridgeback all funds used for the development of EIDD-2801 by Ridgeback have been provided by Wayne and Wendy Holman and Merck. EIDD-2801 was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University. About Ridgeback Biotherapeutics.

Trials 69
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Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

FDA Law Blog: Biosimilars

Not surprisingly, then-presidential candidate Asa Hutchinson, DEA Administrator from 2001 to 2003, did not sign the letter. Rescheduling would eliminate a tax burden on cannabis companies, allowing licensed companies to expand investments into state programs and focus on public health in collaboration with law enforcement efforts.

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PREA and Fixed-Dose Combinations: When Things Get Complicated

The Premier Consulting Blog

The Pediatric Research Equity Act (PREA) was signed into law in 2003 to increase pediatric use information in product labeling and close knowledge gaps regarding the safety, efficacy, and appropriate dosing of drugs to treat children.