Laura Helbling

Washington, D.C.

Senior Writer, The RPM Report and Research Director at Prevision Policy

Director of Research at Prevision Policy; Senior Writer for The RPM Report Covering pharma and biotech regulation and policy.

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Articles

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

1 week ago | insights.citeline.com | Laura Helbling

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. The updated BIOSECURE Act will include adjustments based on issues that arose when the legislation was moving in 2024. (Shutterstock)
US FDA Rare Disease Case Studies Provide Development Models For Sponsors

3 weeks ago | insights.citeline.com | Laura Helbling

US FDA Rare Disease Case Studies Provide Development Models For SponsorsSanofi’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. The rare disease case studies continue FDA efforts to educate sponsors on the best practices for rare disease product development. (Shutterstock)
Vertex Non-Opioid Pain Drug Draws Bipartisan Support In House Hearing

Mar 6, 2025 | insights.citeline.com | Laura Helbling

Vertex Non-Opioid Pain Drug Draws Bipartisan Support In House HearingCongress continues to offer broad support for encouraging alternatives to opioid pain medicine, including proposals to speed coverage of new agents like Vertex’ Journavx. Capitol Hill is pushing for better insurance coverage of non-opioid pain medications. (Shutterstock)
Dose Optimization And Rare Diseases: Doing More With Less

Nov 21, 2024 | insights.citeline.com | Laura Helbling

Dose Optimization And Rare Diseases: Doing More With LessUS FDA officials said dose optimization for rare diseases should not be sacrificed in the name of speeding access to medicines, but is the oncology approach spreading to rare diseases? The FDA said dose optimization may be more important for rare diseases because the small patient populations limit the number of possible clinical trials. (Shutterstock)
Prior Authorization Reform: 2025 Could Be A Year Of Changes

Oct 4, 2024 | pink.citeline.com | Laura Helbling

Analysis Executive Summary Prior authorization reforms could emerge as an important under-the-radar area of drug policy next year. An upcoming Medicare proposed rule, the extraordinary uptake of weight loss therapies, and the launch of the overhauled Part D benefit design will all drive attention to the issue. Source: Shutterstock Existing Subscriber? Sign in to continue reading. New to Pink Sheet?
US PBM Reform: ‘Bust Them Up’ A Theme For 2025?

Aug 2, 2024 | pink.citeline.com | Laura Helbling

Analysis Executive Summary Another House hearing again showcases the bipartisan desire to enact reforms to the US pharmacy benefit management sector. Legislators also sound ready to push for more significant actions than “transparency” measures would promise, but that means waiting until 2025. Source: Shutterstock Existing Subscriber? Sign in to continue reading. New to Pink Sheet?
US Sickle Cell Gene Therapy Contracting Demo Attracting Interest From States

Jul 4, 2024 | pink.citeline.com | Laura Helbling

Analysis Executive Summary The US Medicaid agency says states representing more than 80% of sickle cell patients are interested in a centralized contracting program, but House Republicans want legislation, not administrative interventions, to shape value-based payment for curative therapies. Source: Shutterstock Existing Subscriber? Sign in to continue reading. New to Pink Sheet?
US Medicare Agency Reconsidering Proposed Accelerated Approval Payment Demo

Jun 24, 2024 | pink.citeline.com | Laura Helbling

Analysis Executive Summary The US Medicare agency is not moving forward with a proposal to cut payments for drugs with accelerated approval status pending further discussions with the FDA about whether new regulatory authorities have addressed concerns about timely completion of confirmatory trials. Source: Shutterstock Existing Subscriber? Sign in to continue reading. New to Pink Sheet?
US FDA Drug Center Tries New Approach To Old Consistency Problems

May 27, 2024 | pink.citeline.com | Laura Helbling

Analysis Executive Summary Drug developers should not expect the US FDA's new Quantitative Medicine Center of Excellence to dramatically impact the agency's long-standing problem of ensuring more consistent use of innovative regulatory approaches in application reviews. Source: Shutterstock Existing Subscriber? Sign in to continue reading. New to Pink Sheet? Start a free trial today!
Drug Shortage Could Be Addressed By ‘Resilience Rating’ From Private Entity Under HHS Plan

Apr 9, 2024 | generics.citeline.com | Laura Helbling

Analysis Executive Summary US HHS is proposing a public-private partnership to assign ratings to manufacturers based on quality/resilience of supply, tied to a purchasing incentive program for providers. The non-agency approach may be key to overcoming industry and political objections. You may also be interested in... Existing Subscriber? Sign in to continue reading. New to Generics Bulletin?