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ADUHELM: The First FDA Approved Therapy for Alzheimer’s Disease Since 2003
Lin Zhang
July 20, 2021
Aducanumab, known as ADUHELM, was co-developed by Biogen and Eisai and newly approved by the United States Food and Drug Administration (FDA) on June 7, 2021 (BLA 761178) under the provisions of accelerated approval regulations (21 CFR 601.41).
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Pharmaceutical Companies Back to the Blue Ocean of AD in the Wake of Aduhelm's Approval
PharmaSources/Yefenghong
July 20, 2021
On June 8, the FDA issued an accelerated approval to Biogen/Eisai's powdered protein antibody Aduhelm (generic name aducanumab) for the treatment of Alzheimer's disease (AD).
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Good News in the Anti-AβAntibodies Field, Two Drugs were Successively Granted Breakthrough Drug Qualification by the FDA
PharmaSources/Dopine
July 13, 2021
Two AD drugs have been granted BTD by the FDA recently, namely Eisai/Biogen's Lecanemab (BAN2401) and Eli Lilly's Donanemab.
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Rare Disease Drug 101 - What are the Benefits to Apply for and Receive Orphan Drug Designation?
Lin Zhang
June 29, 2021
There are many common diseases that affect millions of people across the world. On the other hand, there are so-called rare conditions that affect a small number of people.
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New Development of FDA Regulations on Complex Generic Drugs
PharmaSources/Zhulikou431
June 03, 2021
Since the promulgation of the Hatch-Waxman Act in 1984, in order to promote drug competition and improve public drug availability, FDA has formulated a number of policies aimed at accelerating the marketing of generic drugs.
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What’s New on FDA Generic Drugs Forum 2021?
LIN ZHANG
May 08, 2021
Once a year, the Generic Drugs Forum was held on April 28 - 29, 2021 by the FDA Office of Generic Drugs (OGD).
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O-drug Approved as First-line Immunotherapy for Gastric Cancer and What Other Domestic Counterparts to Expect
PharmaSources/Yefenghong
May 08, 2021
O-drug is the first approved immunotherapy for first-line treatment of gastric cancer.
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Top Bulk Deflazacort Powder Manufacturers in China
PharmaSources.com
April 13, 2021
Deflazacort (C25H31NO6) is a glucocorticoid that works as an immunosuppressant and anti-inflammatory. The FDA (Food and Drug Administration) considers it a first-class medication approved in 2017. Generally, it is a corticosteroid prodrug that can ...
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Biosimilars 2020: Low Approvals, but Significant Advances
Neeta Ratanghayra
March 18, 2021
2020 has been a tough year. The pandemic posed an array of challenges to the healthcare system and the global biopharmaceutical industry both rose to the challenges and seized opportunities.
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FDA Orange Book 101
Lin Zhang
February 04, 2021
There are thousands of drugs out there, each with specific benefits, potential side effects, and possible interactions, with many of the drugs being equivalent to one another or serving as alternative treatments for the same issue.