Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Drug Pricing Initiatives During the Trump Presidency
Biosimilars 2018 - A Year in Review
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On 10 April 2024 the European Parliament adopted its position on the draft text on the revision of the European Union’s (EU) general pharmaceutical legislation, also referred to as the (proposed) “EU Pharmaceutical Law...more
On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
Food/Dietary Supplements - FDA Provides Update on Frozen Berry Sampling – The FDA stated, “As of September 30, 2019, the FDA has tested 339 domestic samples and 473 import samples of frozen berries. ...more
As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs...more
Outlook for This Week in the Nation's Capital - Minibus on Senate Floor. The Senate is expected to take up a four-bill spending package next week. ...more
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more