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Prescription Drugs › 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

Robins Kaplan LLP

Liquidia Techs., Inc. v. FDA - Updated 5.2.25

Robins Kaplan LLP on

Nature of the Case and Issue(s) Presented: FDA refused to approve Liquidia’s drug product, Yutrepia because another company, UTC, maintained marketing exclusivity. Liquidia sued FDA, and UTC intervened. The court granted...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

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

Goodwin

Congress Passes Legislation Codifying FDA’s “Active Moiety” Approach to Exclusivity Determinations

Goodwin on

On April 23, 2021, President Biden signed into law the “Ensuring Innovation Act,” which modifies section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 355, by codifying the regulatory approach used by...more

Polsinelli

Update on Pending Legislation: Three New Bills Have the Potential to Affect Generic Pharmaceutical Companies

Polsinelli on

In the first month of the 116th Congress, three bills have been introduced (or re-introduced) that have potential to impact generic pharmaceutical companies. ...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China Drug Administration publishes a key Draft Guidance on data exclusivity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

Mintz - Health Care Viewpoints

Congress Proposes Legislative “Fixes” to Drug Industry Rules Believed to Be Contributing to High Costs

Mintz - Health Care Viewpoints on

We spend a lot of time covering prescription drug costs on this blog, and even convened a Pharmacy Industry Summit earlier this year focusing on the various pressures that are contributing to higher drug prices. Although...more

Goodwin

Biosimilars in India News: Recent Guidelines from India’s CDSCO and a Pending Case on “Biosimilar” Trastuzumab

Goodwin on

A recent court ruling and a new publication on guidelines for biosimilars in India may offer further guidance on what biosimilar and biologic stakeholders can expect from Indian regulatory authorities. In late March,...more

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