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Sales & Distribution Agreements Life Sciences

Goodwin

Biosimilar Manufacturers to Expand Offerings in Europe and Japan

Goodwin on

On June 9, 2025, biosimilar manufacturers Samsung Bioepis and Alvotech announced separate deals to expand their respective offerings in Japan and Europe. ...more

Hogan Lovells

MDCG guidance on QMS certification of distributors/importers relabeling, repackaging medical devices

Hogan Lovells on

In August 2021, the MDCG issued guidance MDCG 2021-23 for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. The...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, February 2021 # 18

Hogan Lovells on

In Washington: The Centers for Disease Control and Prevention (CDC) warned that gym users should wear masks when exercising, even if they are more than six feet apart, and gyms need to improve ventilation. A new agency report...more

Troutman Pepper Locke

Third Circuit Provides Manufacturers With Roadmap to Avoid Class Antitrust Claims Brought by Direct Purchasers

Troutman Pepper Locke on

The Third Circuit recently held in In re Remicade (Direct Purchaser) Antitrust Litigation that a direct purchaser’s antitrust suit alleging overpayment for a drug purchased pursuant to a distribution agreement with a...more

Hogan Lovells

New Brexit Q&A provides several examples in relation to the “placing on the EU market”of products including medical devices

Hogan Lovells on

On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more

Skadden, Arps, Slate, Meagher & Flom LLP

Novel Theories Emerge in Merger Enforcement

Antitrust merger enforcement historically has focused on horizontal mergers — consolidation of two firms that compete directly in the same space. This is especially true in the U.S., where antitrust authorities have...more

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