Laura Helbling
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.
Articles
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1 month ago |
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)
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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)
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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?
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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?
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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?
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FDA's Amy Comstock Rick: Rare Disease Hub planning a sci workshop sched for June, date TBA in May. "Would be irresponsible to make an absolute commitment right now of it it will happen" but planned. topic is designing clin trials for small & diminishing rare disease pops. #bpc
RT @SarahKarlin: and on Novavax app: Marks said he would have resigned after the FDA missed the deadline for the approval decision, if he h…
RT @By_CJewett: Who lost their jobs at the FDA? ☑️ The people who determined if a costly drug was ready to be a generic ☑️ The people tal…