biotech — Lanton Law Blog

CMS Makes An Impactful Change Regarding Biosimilars

Within its final calendar year 2025 Medicare Advantage and Part D final rule seen here, the Centers for Medicare and Medicaid Servces (CMS) is allowing Part D sponsors the ability to make midyear substitutions of biosimilars for their reference products on their formularies.

How to Choose a Lobbyist

Since the early 2000s, there has been a steady increase in the amount of government activity that has directly affected healthcare stakeholders. Prior to this time-period, companies could afford to focus only on differentiating their products from their competitors. Now companies are finding that during their strategic planning meetings, they must account for how state and federal government activity may impact their bottom line. In addition to having a Government Affairs staff, these same companies are starting to realize the importance of having established a relationship with a lobbyist. The question is how do you find the right lobbyist for your organization?

CURES 2.0 Biomedical Legislation Introduced Into Congress

U.S. Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) are back as they recently introduced their long anticipated and bipartisan Cures 2.0 legislation. The bill is discussed via Congresswoman DeGette’s press release.

FDA Approves First Interchangeable Biosimilar for Humira

According to the FDA’s press release, “The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases.”

Illumina Acquires Grail

According to the press release, Illumina announced that it has acquired GRAIL.

Bipartisan Congressional Legislation Introduced Seeking Shared Savings Demo Project to Increase Biological/Biosimilar Medicare Access

U.S. Senators Cornyn (R-TX) and Bennet (D-CO) have introduced the Increasing Access to Biosimilars Act also known as S. 1427. The bill seeks to establish a demonstration project to increase access to biosimilar biological products under the Medicare program.

Biosimilar Legislation Passes Senate

S. 164 titled the Advancing Education on Biosimilars Act of 2021 sponsored by Senator Hassan (D-NH) has passed the Senate on March 3, 2021. The proposed bill seeks to educate health care providers and the public on biosimilar biological products.

Biosimilars Advocacy Group Outlines Congressional Wish List for 2021

The Association for Accessible Medicines sent letters to all members of Congress, which expressed what measures they would like them to take regarding access to biosimilars.

Where Do Biden & Trump Stand On The Issues?

With election season underway many are wondering where the two Presidential candidates stand on the issues of importance to voters.

Reuters did a great summary found here that explains the major differences from the economy, trade, healthcare, etc.

EXIM Policies Impacting Biotechnology & Life Science Stakeholders

The Export-Import Bank of the United States (EXIM) has established some new policies that will impact several stakeholder groups, especially biotechnology, biomedical sciences and life sciences stakeholders.