News & Analysis as of

Manufacturers Pharmaceutical Industry Research and Development

Perkins Coie

BARDA BioMaP-Consortium Up and Running

Perkins Coie on

In a previous Update, we reported on the Biomedical Advanced Research and Development Authority’s (BARDA) plans to implement the new Biopharmaceutical Manufacturing Preparedness-Consortium (BioMaP-Consortium or Consortium),...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Goodwin

Navigating The New Normal: Disruption And Reinvention: The Pivot to Local Supply Chains

Goodwin on

It seems like there is a new article every day about how the COVID-19 pandemic has impacted the supply chain, particularly as economies reopen and we move into the next phase of the “new normal.” The disruptions in the supply...more

Morgan Lewis

FDA Issues More Guidance on Gene and Cell Therapy Products

Morgan Lewis on

January was a busy month for the US Food and Drug Administration’s precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic disorders and guidance on...more

Hogan Lovells

FDA updates industry on what drug & biologic inspections will occur during COVID-19 pandemic

Hogan Lovells on

On Wednesday, August 19, the U.S. Food and Drug Administration (FDA) issued guidance providing some additional insight into how the agency will determine what drug and biologic inspections may take place during the COVID-19...more

Hogan Lovells

China Takes Significant Steps to Consolidate Generic Drug Industry and Lower Prices

Hogan Lovells on

With the opportunity for global pharmaceutical companies to gain new access to the Chinese market presenting itself like never before, significant news broke on December 7, 2018, regarding a newly implemented pilot...more

McDermott Will & Emery

21st Century Cures: A Closer Look

McDermott Will & Emery on

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

Mintz - ML Strategies

Transparency in Drug Pricing: Issues to Consider from the Research Lab to the Consumer

Mintz - ML Strategies on

Since 2014, drug pricing has grown in importance in health care policy conversations. From Gilead Sciences’s Hepatitis C treatment costing $84,000 per course of treatment to Turing Pharmaceutical’s 5,000 percent price hike of...more

Foley & Lardner LLP

Are Drug Prices Really Too High?

Foley & Lardner LLP on

Those working in the pharmaceutical space are used to hearing complaints about the high costs of drugs, and patents often are blamed for allowing pharmaceutical companies to charge “too much” for their products. But are drug...more

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