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Pharmaceutical Regulation

Legal news related to Pharmaceutical Regulation

6 articles

Federal Circuit
•4 min read
Fifth Circuit Court of Appeals

Pharma Giants Challenge Louisiana AG in Consolidated 5th Circuit Appeal

Major pharmaceutical companies including AbbVie, Allergan, and AstraZeneca have filed consolidated appeals in the Fifth Circuit Court of Appeals challenging Louisiana Attorney General Liz Murrill. The consolidated cases involve multiple drug manufacturers opposing the state's top legal officer.

•Multiple major pharmaceutical companies including AbbVie, Allergan, and AstraZeneca are challenging Louisiana Attorney General Liz Murrill in consolidated Fifth Circuit appeals
•Three separate cases have been consolidated under case numbers 24-30645, 24-30651, and 24-30673
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Regulatory
•4 min read

FDA Awards National Priority Vouchers to Two Drug Companies

The U.S. Food and Drug Administration awarded national priority vouchers to two investigational drug products under its new Commissioner's National Priority Voucher pilot program. The vouchers were granted based on the products' potential to increase patient access through improved affordability.

•FDA awarded vouchers under the new Commissioner's National Priority Voucher pilot program
•Two investigational drug products received vouchers based on affordability potential
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Regulatory
•4 min read

Teva Removes 200+ Patent Listings After FTC Challenge

Teva Pharmaceuticals has agreed to remove more than 200 improper patent listings from the FDA's Orange Book after receiving warning letters from the Federal Trade Commission in May 2025. The action opens the market to generic alternatives for over 30 medications including asthma, diabetes, and COPD treatments.

•Teva requested FDA remove 200+ improper patent listings from Orange Book after FTC warning letters
•Removals affect generic competition for 30+ drugs including asthma, diabetes, COPD medications and epinephrine autoinjectors
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Regulatory
•4 min read

FDA Approves First Drug Under New Priority Voucher Program

The FDA approved Augmentin XR as the first drug under its new Commissioner's National Priority Voucher pilot program. This milestone marks a new regulatory pathway designed to strengthen domestic antibiotic manufacturing capacity.

•Augmentin XR becomes first drug approved under FDA's new Commissioner's National Priority Voucher pilot program
•Program aims to strengthen domestic antibiotic manufacturing and reduce foreign supply dependence
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Regulatory
•1 min read

FDA Approves First CAR T-Cell Therapy for Marginal Zone Lymphoma

The U.S. Food and Drug Administration approved Breyanzi (lisocabtagene maraleucel) as the first CAR T-cell therapy for marginal zone lymphoma in the United States. The approval marks a significant advancement in treatment options for patients with this rare form of blood cancer.

•First CAR T-cell therapy approved specifically for marginal zone lymphoma treatment in the US
•Breyanzi uses genetically modified patient immune cells to target cancer
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State Court
•4 min read
Texas Supreme Court

Texas Supreme Court Denies Novartis Mandamus Petition

The Texas Supreme Court denied a petition for writ of mandamus filed by Novartis Pharmaceuticals Corporation, with two justices issuing a statement highlighting constitutional concerns about qui tam litigation under the Texas Health Care Program Fraud Prevention Act.

•Texas Supreme Court denied Novartis's mandamus petition citing new appellate court jurisdiction
•Justices Young and Sullivan highlighted constitutional concerns about qui tam litigation under Texas healthcare fraud law
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