Knowledge Base - Massachusetts Biotechnology Council - Massachusetts Biotechnology Council

Collection of Genetic and Biometric Data Within EU GDPR May 22, 2018 in Advisories

As GDPR takes effect this week, we expect some provisions to affect U.S-based life sciences companies conducting clinical trials at EU sites. Read More

How Recent Tax Law Changes May Affect Your Equity Compensation Benefits Freedom Trail Financial May 9, 2018 in White Papers,

Workforce Development

The U.S. tax code is always evolving, and the Tax Cuts and Jobs Act of made significant changes that will affect anyone who earns equity compensation. Read more for a few highlights from this new law. Read More

Rare Disease Day 2018: Social Listening Report Getfused, Inc. May 3, 2018 in White Papers,

Advocacy

We tracked social media conversation on #RareDiseaseDay in 2018 and put together a report summarizing patient conversation. Read More

Understanding sunshine rules: how new transparency regulations in Europe are changing relationships between industry and health care professionals Hogan Lovells May 2, 2018 in Presentation & Video Library

In this interview, Hein van den Bos and Ron Wisor say that while sunshine rules are still evolving, the industry needs to know that the transparency enforced by these regulations is here to stay. Read More

What device companies need to know ahead of an advisory panel meeting Hogan Lovells May 2, 2018 in Presentation & Video Library,

FDA

In this video interview, Gerard (Gerry) Prud'homme and Kristin Zielinski Duggan share six key points to keep in mind when preparing for an advisory panel meeting. Read More

Outlook for OTC Drug Regulation Hogan Lovells May 2, 2018 in White Papers,

Through a combination of new legislation, regulations, and enforcement policies, a new regulatory framework is coming for OTC drugs. Read More

Investing Perspectives From Leo Tolstoy Freedom Trail Financial April 27, 2018

As long-term investors, we need to focus on economic fundamentals and understand that volatile markets may require us to periodically reexamine our financial goals, risk tolerance, and time-horizon. Read More

Pricing for Survival: As demand for pharmaceutical cost containment intensifies, novel drug-pricing approaches are critical KPMG LLP April 19, 2018 in White Papers,

Drug Cost,
Value

In this piece, we explore the practical approaches to pricing for value that pharma manufacturers can leverage today. Read More

House Passes “Right to Try” bill – Compromising Public Health and Drug Development April 18, 2018 in Advisories

“Right to Try” would provide access to experimental therapies to patients with life-threatening illnesses while weakening FDA oversight and compromising public health and medical research. Read More

Are You Ready for USCIS H-1B Site Visits or Department of Labor Audits? Foley Hoag LLP April 16, 2018 in Checklists,

Now that the FY 2019 H-1B cap has been reached, make sure you have a strong immigration compliance programs in place. Read More