MoFo Life Sciences

June 16, 2023 - Intellectual Property, Litigation, United States, Biotech, Pharma
Five Questions after Amgen v. Sanofi
By: Meghan McLean Poon Ph.D. and Kelsey J. Roberts Kingman Ph.D.
The Supreme Court’s recent decision in Amgen v. Sanofi puts a spotlight on enablement of functionally defined claims. Future developments may shed light on a number of remaining questions for patent applicants. Here are five areas to watch: 1. What is the impact on
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April 25, 2023 - European Union, Regulatory, Pharma, Healthcare, Privacy + Data Security
Key Considerations for Sponsors of Clinical Trials Under the EU Clinical Trial Regulation
By: Robert Grohmann, Alex van der Wolk and Marta Hovanesian
Clinical trials play a crucial role in the development of new medicines and medical devices, but conducting clinical trials involves ethical, legal, and regulatory challenges. As reported in our latest article, Prevent a Clinical Trial from Turning into a Criminal Trial , the United
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April 21, 2023 - Intellectual Property, Litigation, Pharma, Biotech, United States
Is DOE Now in Vogue?
By: Matthew A. Chivvis and Qiwen Zhong Ph.D.
On March 27, 2023, the U.S. Supreme Court heard oral arguments in Amgen Inc. v. Sanofi , a closely watched case on the issue of enablement under 35 U.S.C. § 112(a). Though not the main point of contention, the doctrine of equivalents (DOE) was
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March 24, 2023 - Pharma, Healthcare, United States
CMS Announces Part B Prescription Drugs with Lower Coinsurance Amounts for Q2 2023
The Inflation Reduction Act of 2022 requires drug companies to pay rebates to Medicare when prescription drug prices increase faster than the rate of inflation for certain drugs. This inflation rebate applies to Medicare Part B rebatable drugs, which are single-source drugs and biological
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March 23, 2023 - Biotech, Pharma, Licensing + Commercial, Asia, Regulatory
China Eyes New Export Controls for Life Sciences Technologies
By: Tyler Xiu, Bu Yin Ph.D., Gordon A. Milner, Chuan Sun and Janet Xiao Ph.D.
China is considering new export restrictions on advanced technologies, including, in particular, in the life sciences sectors. In late December 2022, China’s Ministry of Commerce (“ MOFCOM ”) issued the proposed amendment to the country’s Catalogue of Technologies Prohibited and Restricted for Export (the
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March 01, 2023 - Healthcare, Pharma, Regulatory, Litigation, United States
States Extend Scope of Regulatory Oversight of Health Care Entities
The proliferation of private investor-backed management of health care practices continues to draw scrutiny from regulators into the impact on patient care, health care costs, and access to services. State regulators play a key role in monitoring and challenging anticompetitive behavior at the local
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February 28, 2023 - Healthcare, Pharma, Litigation, Regulatory, United States
CMS Releases Guidance on the Medicare Prescription Drug Inflation Rebate Program
The Inflation Reduction Act of 2022 (IRA) was signed into law on August 16, 2022 and includes several provisions to lower prescription drug costs for Medicare beneficiaries and reduce drug spending by the federal government. One provision of the IRA requires drug manufacturers to
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February 16, 2023 - COVID-19, United States, FDA, Medical Devices + Diagnostics, Healthcare, Pharma
Ending the COVID-19 Public Health Emergency – What Happens Next
The Biden administration announced on January 30, 2023, that it plans to terminate the COVID-19 public health emergency declaration (the “PHE declaration”) on May 11, 2023. COVID-19 EUA medical products and policies As FDA has clarified in its draft transition guidance for medical devices
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February 08, 2023 - FDA, Pharma, Medical Devices + Diagnostics, Rare Disease, United States
FDORA Passage Brings Significant Changes to FDA’s Drug, Device, and Cosmetic Authorities
By: Brigid DeCoursey Bondoc
The Consolidated Appropriations Act for 2023 was signed into law on December 29, 2022 and includes the Food and Drug Omnibus Reform Act (FDORA). FDORA authorizes a variety of new and important amendments to the Food, Drug, and Cosmetic Act (FDCA) governing drugs, medical
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February 08, 2023 - Privacy + Data Security, Pharma, Healthcare, United States, Digital Health
FTC Brings First Enforcement Action of the Health Breach Notification Rule
By: Melissa M. Crespo
The Federal Trade Commission (FTC) has enforced its Health Breach Notification Rule (the “HBNR”) for the first time since it was enacted in 2009. On February 1, the FTC announced a first-of-its-kind proposed order (the “Order”) with digital health platform GoodRx Holdings Inc. (“GoodRx”),
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Topic Archives: Pharma

Five Questions after Amgen v. Sanofi

By: Meghan McLean Poon Ph.D. and Kelsey J. Roberts Kingman Ph.D.

Key Considerations for Sponsors of Clinical Trials Under the EU Clinical Trial Regulation

By: Robert Grohmann, Alex van der Wolk and Marta Hovanesian

Is DOE Now in Vogue?

By: Matthew A. Chivvis and Qiwen Zhong Ph.D.

CMS Announces Part B Prescription Drugs with Lower Coinsurance Amounts for Q2 2023

China Eyes New Export Controls for Life Sciences Technologies

By: Tyler Xiu, Bu Yin Ph.D., Gordon A. Milner, Chuan Sun and Janet Xiao Ph.D.

States Extend Scope of Regulatory Oversight of Health Care Entities

CMS Releases Guidance on the Medicare Prescription Drug Inflation Rebate Program

Ending the COVID-19 Public Health Emergency – What Happens Next

FDORA Passage Brings Significant Changes to FDA’s Drug, Device, and Cosmetic Authorities

By: Brigid DeCoursey Bondoc

FTC Brings First Enforcement Action of the Health Breach Notification Rule

By: Melissa M. Crespo