CER Daily Newsfeed

The Comparative Effectiveness Research Daily Newsfeed®, known for short as the CER Daily Newsfeed®, offers the latest news, research and related information on comparative effectiveness research, real-world data and evidence, value assessment and other important health care topics. 

News from Wednesday, May 22, 2024

Articles

The Looming US Election Weighs On The Minds Of Pharma

(5/21, Jessica Merrill, Pink Sheet) reports “...National Pharmaceutical Council President and CEO John O'Brien...countered that while a Trump administration might be unpredictable, a Biden administration poses known risks to the industry. ‘I can't predict what a future Trump administration would do,’ he said. ‘I can predict, based on the State of the Union, that another Biden term would be doubling down on the Inflation Reduction Act, whether that's more drugs, turning the dial to the to the left and changing some of the ceiling prices or trying to sweep more drugs in even earlier.’” Subscription Required

 

Appeals Court Sides with Drug Manufacturers in 340B Case

(5/22, Susan Morse, Healthcare Finance News) reports “...The district court held that 340B does not prohibit manufacturers from limiting the distribution of discounted drugs by contract. The appeals court agreed. ‘In sum, we hold that section 340B does not categorically prohibit manufacturers from imposing conditions on the distribution of covered drugs to covered entities. We further hold that the conditions at issue here do not violate section 340B on their face. We do not foreclose the possibility that other, more onerous conditions might violate the statute.’” Full

 

What Clinical Real-World Data Can Deliver

(5/22, Jenna Phillips, STAT) comments “...Real-world data provide new insights into the care clinicians deliver and patients receive. Clinical notes and medical records can help understand clinician and patient perspectives and identify unmet needs that can be translated into new research to meet those requirements. For example, analyses of real-world clinical data have in some cases identified safety signals of therapeutics and diagnostics on the market that suggested a need for additional research, or additional monitoring requirements or expectations.” Full

Press Releases

COTA Announces Extended Collaboration with FDA to Advance the Use of Real-World-Data in Cancer Research

(5/22, COTA Press Release) “...This collaboration will facilitate the use of new oncology data sources to support the mission of the OCE Scientific Collaborative. Additionally, the collaboration will support a better understanding of the use of therapies and associated diagnostics in real-world settings, along with exploration of the modifiable and non-modifiable factors influencing outcomes in real-world practice to inform regulatory science objectives.” Full

 

Rhythm Pharmaceuticals Receives Positive Recommendation from NICE for IMCIVREE® (setmelanotide) for Treatment of Obesity and Hyperphagia in Patients with Bardet-Biedl Syndrome

(5/22, Rhythm Pharmaceuticals Press Release) “Rhythm Pharmaceuticals, Inc...today announced the National Institute for Health and Care Excellence (NICE) has issued guidance that recommends IMCIVREE® (setmelanotide) as an option for treating obesity and the control of hunger (hyperphagia) in genetically confirmed Bardet-Biedl syndrome (BBS) in people 6 years of age and over, if they are between 6 and 17 years of age when treatment starts.” Full

Journals

Comparative Effectiveness of Myocardial Patches and Intramyocardial Injections in Treating Myocardial Infarction with a MitoQ/Hydrogel System

Ying Tan, et al.

May 21, 2024, Journal of Materials Chemistry

PubMed

 

Stakeholders’ Involvement in Health Technology Assessment in Kazakhstan, Poland and Bulgaria

Kulembekova L, et al.

May 22, 2024, Patient Preference and Adherence

Patient Preference and Adherence