Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
[IP Hot Topics Podcast] Innovation Conversations: Dr. Claire Fraser
Nota Bene Episode 71: Shifting Regulatory Landscapes at the FDA: Cannabis, Vaping and Intelligent Medical Devices with Allison Fulton
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Podcast: Non-binding Guidance: Expedited Review Programs for Drugs and Biologics
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
A changing competitive landscape: the role of the ITC in the biosimilars space
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more
On February 28, 2024, following the European Commission's four 2023 proposals, the European Parliament adopted a legislative resolution on the amended proposal to create a Unitary Supplementary Protection Certificate ("USPC")...more
Antitrust and Competition - European Commission Charges Company with Providing Incorrect, Incomplete, and Misleading Information During a Merger Control Proceeding - On 19 March 2024, the European Commission (Commission) sent...more
Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD). Teva entered into a strategic...more
During the first quarter of 2021, multiple companies launched adalimumab biosimilars as a growing number of biosimilar players marketed their versions of the world’s most profitable drug, Humira®, which had sales of about $20...more
The European Commission has approved mAbxience’s bevacizumab biosimilar, MB02, for marketing in Europe. As we previously reported, MB02, which will be known as Alymsys and Oyavas, is intended for the treatment of colon or...more
On 11 March 2021, GCR hosted a series of interactive webinars. Our global co-head of antitrust, Elaine Johnston, participated in the panel that looked at the development of biologics and the role that antitrust has to play in...more
The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorisations from stakeholders....more
In December, we reported that the European Commission ("Commission") had issued an Interpretive Notice (2016/C 411/03) stating products produced by essentially biological processes should not be patentable. The notice came as...more
While the U.S. is still sorting out “natural products” jurisprudence under 35 USC § 101, the European Patent Office (EPO) is wrestling with the patentability of plants and animals, and has announced an immediate stay on all...more