EU’s Overhaul Of Pharma Legislation Amended With Uneasy IP Compromises

On March 19, 2024, a set of 100 “Compromise Amendments” to the European Commission’s far-reaching overhaul of the EU’s rules for medicines, the Pharmaceutical Review, was adopted by the European Parliament’s ENVI Committee. Maarten Meulenbelt, Chris Boyle and Zina Chatzidimitriadou explain the main changes, associated risks, and next steps.

Chinese Parties to International Licensing Deals Should Consider How Terms Translate

Licensing deals are still relatively new in China compared to the United States and Europe. Tom Duley and Ruchun Ji explain why this means Chinese parties need to be careful about the history of terms and the choice of governing law and arbitration venue when negotiating contracts.

Points To Check When Selling Food Supplements Outside The U.S.

Major U.S. companies are expanding their vitamins, minerals, and botanicals businesses into Europe. Diane McEnroe, Anna-Shari Melin, and Nadja Schwarz explain what to consider in relation to formulation, labelling, and marketing language when targeting this market.

Deal Outlook for 2024 Includes GLP-1 Investments, APAC M&A, and More Spinoffs

Our lawyers share the top investment and regulatory trends from last month’s agenda-setting JP Morgan Health Care Conference. We expect an abundance of novel financing structures, investment focus on new disease states, and important new U.S. Food and Drug Administration (FDA) guidance.

Life Sciences Companies with Operations in EU Could Be Affected by ESG Law

EU member states are beginning to implement EU environmental, social, and governance (ESG) legislation into national law, meaning life sciences companies will need to look at its impact on their global supply chains, including for APIs. Michele Tagliaferri, Anna-Shari Melin, and Nadja Schwarz explain.

FDA Publishes New Draft Guidance Essentially Clarifying that the Human Drug GMP Guidelines (ICH Q7) Apply to the Manufacture of Veterinary Active Pharmaceutical Ingredients

FDA has published new draft guidance on the safe manufacturing of active pharmaceutical ingredients (APIs) for animal drugs. Following a consultation period, it is also expected to be implemented in Japan, the EU, and the UK. Chris Fanelli, Dr. Chris Boyle, and Dan Roberts discuss what the new guidance means for animal drug manufacturers.

Beyond Technology: Embracing Blockchain for a Paradigm Shift in Life Sciences

Blockchain is not only the preserve of the fintech industry, but may have multiple uses for life sciences companies, including providing a consent structure for clinical trials to give enhanced patients more control over their own data. Sidley’s Eva von Mühlenen and Daniel Fritz, executive director of the PharmaLedger Association, explain.

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