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Life Sciences › Pharmaceutical Industry › Exclusivity

American Conference Institute (ACI)

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

American Conference Institute (ACI) on

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)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

American Conference Institute (ACI) on

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

Goodwin

The European Commission Proposes First Major Overhaul of the EU Medicines Regulatory Framework in 20 Years: Regulatory Data...

Goodwin on

We recently published an alert in relation to the European Commission’s legislative proposals to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children). One of the...more

McDermott Will & Schulte

[Ongoing Program] Life Sciences Session: Pharma Brands v. Generics: Developments Affecting the Balance Between Exclusivity and...

McDermott Will & Schulte on

We are committed to providing insightful commentary on IP developments from around the world to our Japanese clients. In light of that effort, we are continuing our free monthly webinar series, McDermott IP Focus. During...more

Morgan Lewis - Tech & Sourcing

Important Considerations When Tech Service Providers and Life Science Companies Collaborate in the Digital Health Space

Morgan Lewis - Tech & Sourcing on

When negotiating a digital health collaboration agreement between a tech company and a life sciences company, whether for the development of artificial intelligence or other software, the provision of data hosting and...more

MoFo Life Sciences

Pediatric Exclusivity For Biologics

MoFo Life Sciences on

The U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with certain distinctions), which may become a valuable life cycle management strategy...more

Hogan Lovells

China Drug Administration publishes a key Draft Guidance on data exclusivity

Hogan Lovells on

This is the first time the China Drug Administration (CDA) provides details on how the data exclusivity applies to pre-clinical and clinical data submitted to the agency. Companies with plans to launch pharmaceutical products...more

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