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Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law Blog: Biosimilars

Federal Court Orders Puerto Rico Pharmaceutical Distributor to Pay $12 Million in Connection with Alleged Failure to Report Suspicious Orders of Pharmaceutical Drugs and Other Controlled Substance Violations, Nov. 6, 2023 ( DOJ Press Release ). Holiday CVS, L.L.C. d/b/a CVS/Pharmacy, Nos. 219 and 5195; Decision and Order , 77 Fed.

Pharmacy 139
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The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation”

FDA Law Blog: Biosimilars

Vanda Pharmaceuticals, Inc. Under the Medicaid Drug Rebate statute, a pharmaceutical manufacturer whose drug prices increase faster than the rate of inflation must pay additional per-unit rebates to the program. Vanda Pharmaceuticals, Inc. Centers for Medicare and Medicaid Servs., 23-1457 (4th Cir. MJM-22-977 (Dist.

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CHOICE-01 Phase III Study of Toripalimab at the Interim Analysis Met Pre-Specified Primary Endpoint of Progression-Free Survival at the First-Line Treatment of Advanced NSCLC

The Pharma Data

About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics.

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Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing

FDA Law Blog: Biosimilars

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act.

FDA 59
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FDA Grants Toripalimab Fast Track Designation for Mucosal Melanoma

The Pharma Data

About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics.

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CMS Definition of “New Formulation” Upheld in Federal Court

FDA Law Blog: Biosimilars

Vanda Pharmaceuticals, Inc. This objection echoed a criticism that had been expressed by industry ever since CMS’s proposed rule in 2012. Kirschenbaum — On March 31, the Federal District Court for the District of Maryland upheld CMS’s definition of a “new formulation” under the Medicaid Drug Rebate Program (MDRP). MJM-22-977 (Dist.

Drugs 59
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New Sandoz Board of Directors appointed

The Pharma Data

Since 2012, she serves as board member and currently as chair of the Audit Committee of Tecan Group, a Swiss listed company. He also served on 2 Boards of Directors at Takeda Pharmaceuticals between 2013 and 2015 and Britannia Industries, India, between 2000 and 2008. François-Xavier Roger, Chief Financial Officer of Nestlé S.A.,

Science 40