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Life Sciences › Generic Drugs › Biopharmaceutical

American Conference Institute (ACI)

[Virtual Conference] Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 14th - 30th, 1:00 pm EST

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ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more

American Conference Institute (ACI)

[Event] 21st Annual Conference on Paragraph IV Disputes - April 29th - 30th, New York, NY

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Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...more

Smart & Biggar

Top 10 patent and regulatory things you need to know when bringing a biopharma product to Canada

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Canada is an attractive market for pharmaceutical manufacturers. While universal healthcare does not currently extend to drugs in an outpatient setting, most Canadian consumers have some form of drug coverage through...more

Proskauer - The Patent Playbook

In the Orphan Drug Approval Race, Winner Takes All? Ramifications of Catalyst Pharms. v. Becerra

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How is orphan drug exclusivity affected when the FDA-approved use for an orphan drug is arguably narrower than the treatment of the rare disease it was designated for? By way of background, a sponsor can obtain orphan drug...more

Hogan Lovells

China: Survival of the Fittest or Cheapest?

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The past year is set to be a milestone year for China’s pharmaceutical regulatory reform as the newly formed National Medical Products Administration (NMPA) continues to aggressively cut back on red tape for new drug...more

Fish & Richardson

Legislative Developments in Post-Grant Proceedings

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Amidst a spate of high-profile IPR filings in the life sciences space by hedge fund financiers, the biotechnology industry has mobilized behind two chief legislative strategies designed to limit or eliminate its exposure to...more

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