Hogan Lovells | Pharmaceuticals and Biotechnology Regulatory
6 FOLLOWERS
Stay ahead of the latest legal, market, and regulatory developments. Hogan Lovells publishes content on pharmaceutical and biotechnology law along with other relevant topics.
Hogan Lovells | Pharmaceuticals and Biotechnology Regulatory
1w ago
Hogan Lovells | Pharmaceuticals and Biotechnology Regulatory
2w ago
On 10 April 2024 the European Parliament adopted its position on the draft text on the revision of the European Union’s (EU) general pharmaceutical legislation, also referred to as the (proposed) ..read more
Hogan Lovells | Pharmaceuticals and Biotechnology Regulatory
1M ago
On February 16, 2024, the U.S. District Court for the District of Oregon issued a ruling in Pharmaceutical Research and Manufacturers of America (PhRMA) v. Stolfi, granting in part PhRMA’s motion ..read more
Hogan Lovells | Pharmaceuticals and Biotechnology Regulatory
1M ago
The Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), ..read more
Hogan Lovells | Pharmaceuticals and Biotechnology Regulatory
1M ago
On April 2, 2024, the Centers for Medicare & Medicaid Services (CMS) released the 2025 Notice of Benefit and Payment Parameters (NBPP) final rule (Final Rule), finalizing policies applicable to qualified ..read more
Hogan Lovells | Pharmaceuticals and Biotechnology Regulatory
1M ago
With the recent filing of an amicus brief in a private pharmaceutical patent infringement case, the Federal Trade Commission (FTC) has continued its focus on allegedly “improperly listed” ..read more
Hogan Lovells | Pharmaceuticals and Biotechnology Regulatory
1M ago
Today, 20 March 2024, the European Commission issued an important Communication aimed at boosting biotechnology and biomanufacturing in the EU. These sectors are identified as key strategic areas with ..read more
Hogan Lovells | Pharmaceuticals and Biotechnology Regulatory
1M ago
Today, the U.S. Food and Drug Administration (FDA) published the draft guidance “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products,” ..read more
Hogan Lovells | Pharmaceuticals and Biotechnology Regulatory
1M ago
In a ruling with significant implications for companies facing sham-litigation claims, such as those that can arise in the Hatch-Waxman context for pharmaceutical manufacturers, the Third Circuit recently ..read more
Hogan Lovells | Pharmaceuticals and Biotechnology Regulatory
1M ago
As part of its broader efforts to improve the informed consent process for prospective study participants, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) ..read more