“Refreshed” UK-wide Innovative Licensing and Access Pathway (ILAP) Applications Now Open

Commercial and pre-commercial developers of potentially transformative medicines or drug-device combination products can now utilize a unique accelerated regulatory pathway in the UK. Article authored by Marie Manley and Victoria Kerr. (more…)

Unauthorized Drug Importation by Alternative Funding Programs: What Pharmaceutical Companies Need to Know and Options on How to Respond

Some entities known as Alternative Funding Programs (AFPs) are engaged in the unauthorized importation of specialty drugs into the United States and may pose a growing threat to the U.S. drug supply. Article authored by Benjamin B. Correa and Kathy P. Lee.

Referral Payments Targeted in New Special Fraud Alert

A Special Fraud Alert has been issued by the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG), warning that certain marketing arrangements relating to Medicare Advantage beneficiary referrals could potentially result in “abusive arrangements.” Jon Zucker explains.

How Life Sciences Companies Can Respond To DOJ’s Focus on Clinical Trial Fraud

For the past two years, clinical trial fraud has been a key enforcement area for the U.S. Department of Justice’s (DOJ) Consumer Protection Branch (CPB). David Ludlow and Julea Lipiz set out considerations for life sciences companies to help mitigate scrutiny of their trial results and related products. 

The AI Revolution and the FDA: Becky Wood and Deeona Gaskin’s Fireside Chat with Former FDA Commissioner Dr. Scott Gottlieb

AI tools are already advancing patient care by opening up new avenues for drug and product discovery, evaluation, and pharmacovigilance. But they also raise regulatory challenges as our panelists discuss.

SEC Interest in FDA-Related Disclosures by Life Sciences Companies Highlighted

A recent SEC enforcement action against Cassava Sciences over misleading statements made to the FDA about clinical trial (CT) results highlights the importance of life sciences companies exercising care in how they disclose FDA-related information to investors. Lara Mehraban explains.

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Risks and Benefits of Generative AI for Pharma Supply Chain Management

As the life sciences sector grapples with complex challenges around sustainability and Environmental and Social Governance (ESG) compliance, Generative AI (GenAI) is emerging as a potentially powerful tool for enhancing efficiency and sustainability. Michele Tagliaferri, Eva von Mühlenen, and Anna-Shari Melin explain. (more…)

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