MoFo Life Sciences

January 17, 2023 - FDA, Regulatory, United States, Pharma
FDA Enables Pharmacies to Dispense Abortion-Inducing Mifepristone in Revised REMS
By: Stacy Cline Amin, Brigid DeCoursey Bondoc and Kate Driscoll
On January 3, 2023, the U.S. Food & Drug Administration (FDA) modified the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program to remove the in-person dispensing requirement and allow dispensing of mifepristone at certified retail pharmacies. FDA announced this forthcoming modification in December 2021
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December 14, 2022 - Intellectual Property, Pharma, Regulatory, European Union
Relabeling vs. Repackaging: CJEU Backs Drug Manufacturers’ Position Against Parallel Importers
By: Robert Grohmann
In two recent landmark decisions, Novartis v. Abacus (C ‑ 147/20) and Bayer v. kohlpharma (C-204/20), the Court of Justice of the European Union ( CJEU ) strengthened the position of drug manufacturers against repackaging practices of parallel importers. The court held that, based
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November 29, 2022 - FDA, Healthcare, Digital Health, Regulatory, Pharma, United States
CMS Publishes Final 2023 Medicare Physician Fee Schedule—Key Takeaways for Telehealth Companies
By: Wendy C. Chow
On November 1, 2022, the Centers for Medicare and Medicaid Services (CMS) published the final 2023 Medicare Physician Fee Schedule (“2023 Fee Schedule”). Although the 2023 Fee Schedule most notably sets the rates for Medicare services for the coming year, the rulemaking also traditionally includes
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November 17, 2022 - FDA, Healthcare, Digital Health, Regulatory, Pharma
FDA Clarifies ANDA Active Ingredient Sameness Evaluation in Draft Guidance
By: Stacy Cline Amin and Brigid DeCoursey Bondoc
On November 8, 2022, FDA issued a draft guidance document on Sameness Evaluations in an ANDA — Active Ingredients (“Draft Guidance”). In the Draft Guidance, FDA indicated that the active ingredient’s chemical form will generally be the entire molecule, but it may also encompass
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August 25, 2022 - Pharma, Intellectual Property, Litigation
Last Week in the Federal Circuit (August 15 – August 19): The Court Rebuffs Patent Owner’s Attempt to Read Anda Application in Isolation
By: Brian R. Matsui
Our Federal Circuitry blog recently discussed the Court's decision in Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc. , No. 21-2342. You should read this case if: you have an ANDA case involving “actual, real-world evidence” that might conflict with what the ANDA says For our
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May 26, 2022 - United States, FDA, Healthcare, Pharma, Regulatory, Intellectual Property
Senators Call for Report on State of Psychedelic Research
By: Stacy Cline Amin
Thanks to our Life Sciences Transactions + Licensing Group, including Matthew Karlyn, Mai Zymaris, and Hannah Koo, for contributing to this post. Earlier this month, Senators Brian Schatz (D-HI) and Cory Booker (D-NJ) sent a letter to the National Institutes of Health (NIH) and
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March 15, 2022 - United States, Litigation, Biotech, Healthcare, Pharma, Intellectual Property
Possession of an "Effective" Dose
By: Kelsey J. Roberts Kingman and Bu Yin
Update: On March 16, 2022, the U.S. Court of Appeals for the Federal Circuit denied Biogen International’s petition for panel rehearing and rehearing en banc , following a November split decision discussed below. Judges Lourie, Moore, and Newman dissented on the denial of en
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March 14, 2022 - United States, Healthcare, Pharma, Regulatory
New Jersey Court Affirms Prohibition of Physician Practice from Opening and Operating In-Office Pharmacy
At the end of 2021, the Superior Court of New Jersey, Appellate Division upheld the decision by the New Jersey Board of Pharmacy (the “Board”) denying the application from a New Jersey oncology practice (the “Petitioner”) to register, open, and operate a pharmacy within
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March 09, 2022 - Global, FDA, Healthcare, Pharma, Regulatory
FDA’s Loud and Clear Message: Engage with FDA Early and Formally
By: Brigid DeCoursey Bondoc
On February 10, 2022, the U.S. Food and Drug Administration (FDA) held a public Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the sintilimab application based on the ORIENT-11 trial conducted exclusively in China. Rather than following the traditional paradigm of assessing the risk-benefit profile
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February 25, 2022 - United States, FDA, Healthcare, Pharma, Regulatory
Fluoride Supplement Manufacturer Forced to Address Misleading Labeling Allegations
By: Brigid DeCoursey Bondoc
Earlier this month, the U.S. District Court for the Middle District of Alabama decided Method Pharmaceuticals, LLC v. H-2 Pharma, LLC , a dispute concerning labeling for fluoride products that raised a variety of issues with broader implications for industries regulated by the U.S.
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Topic Archives: Pharma

FDA Enables Pharmacies to Dispense Abortion-Inducing Mifepristone in Revised REMS

By: Stacy Cline Amin, Brigid DeCoursey Bondoc and Kate Driscoll

Relabeling vs. Repackaging: CJEU Backs Drug Manufacturers’ Position Against Parallel Importers

By: Robert Grohmann

CMS Publishes Final 2023 Medicare Physician Fee Schedule—Key Takeaways for Telehealth Companies

By: Wendy C. Chow

FDA Clarifies ANDA Active Ingredient Sameness Evaluation in Draft Guidance

By: Stacy Cline Amin and Brigid DeCoursey Bondoc

Last Week in the Federal Circuit (August 15 – August 19): The Court Rebuffs Patent Owner’s Attempt to Read Anda Application in Isolation

By: Brian R. Matsui

Senators Call for Report on State of Psychedelic Research

By: Stacy Cline Amin

Possession of an "Effective" Dose

By: Kelsey J. Roberts Kingman and Bu Yin

New Jersey Court Affirms Prohibition of Physician Practice from Opening and Operating In-Office Pharmacy

FDA’s Loud and Clear Message: Engage with FDA Early and Formally

By: Brigid DeCoursey Bondoc

Fluoride Supplement Manufacturer Forced to Address Misleading Labeling Allegations

By: Brigid DeCoursey Bondoc