Laura Helbling

Laura Helbling

Senior Writer-Pink Sheet

Washington, DC

Latest from Laura Helbling

Generic Drug Onshoring: Bipartisan Support For Federal Procurement Reforms

A Senate hearing on the medical product supply chain suggests there is bipartisan support for ‘buy American’ policies for federal Rx purchases, and for country-of-origin labeling to help those policies expand to the private sector.

Non-Opioid Analgesics Guidance On Chronic Pain: One Trial Plus Confirmatory Evidence May Be Enough

Alternative therapies designed to avoid, eliminate, or reduce the use of opioids may be eligible for Breakthrough Therapy Designation or Priority Review, the US FDA draft guidance says.

US Strategic Reserve Bulking Up: New Order Focuses On API Stockpile

The White House is directing the Health and Human Services Department to replenish stockpiles of active pharmaceutical ingredients for “especially critical” medicines.

BIOSECURE Act Returning, Privacy, Gain-of-Function Bills Coming, Senate Sponsor Says

Legislation prohibiting work with certain Chinese biopharma firms will be reintroduced soon, Democratic Sen. Gary Peters said. And it will not be the only bill tied to international biotech competition and security concerns that will be considered.

US FDA Rare Disease Case Studies Provide Development Models For Sponsors

Sanofi’s Xenpozyme and Sentynyl’s Nulibry are the first two case studies the FDA is using to continue educating rare disease sponsors on best practices.

Vertex Non-Opioid Pain Drug Draws Bipartisan Support In House Hearing

Congress continues to offer broad support for encouraging alternatives to opioid pain medicine, including proposals to speed coverage of new agents like Vertex’ Journavx.