News from Thursday, January 30, 2025
Articles
Trump Administration Makes First Comments On How it Will Run IRA Drug Negotiations
(1/29, Nicole DeFeudis, Endpoints News) reports “The Trump administration said on Wednesday it will consider ‘opportunities to bring greater transparency’ to the Medicare drug price negotiation process under the Inflation Reduction Act. With the second cycle of negotiations set to begin in a month, CMS said in a statement that it is ‘committed to incorporating lessons learned to date from the program.’ The administration said lowering drug prices will be a ‘top priority,’ and that it intends to give stakeholders the opportunity to ‘provide specific ideas to improve the negotiation program.’” Full
UK: MHRA Launches Refreshed ILAP to Speed Up NHS Drug Access
(1/30, Jenna Philpott, Pharmaceutical Technology) reports “...The revised pathway, developed by the MHRA alongside the All Wales Therapeutics and Toxicology Centre (AWTTC), the National Institute for Health and Care Excellence (Nice), the Scottish Medicines Consortium (SMC) and the National Health Service (NHS), aims to streamline collaboration between medicine developers and the national health systems.” Full
UK: Sanofi’s Sarclisa Combination Approved by MHRA for Newly Diagnosed Multiple Myeloma
(1/30, Emily Kimber, PMLiVE) reports “Sanofi’s Sarclisa (isatuximab) has been approved by the Medicines and Healthcare product Regulatory Agency (MHRA) as part of a combination treatment for newly diagnosed multiple myeloma (MM). The regulator has approved the drug for use alongside standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) to treat adults who are ineligible for autologous stem cell transplant (ASCT).” Full
India: Round Table Conference on RWE Brings Together Eminent Experts from India & Europe to Discuss Future of RWE
(1/30, Shardul Nautiyal, Pharmabiz.com) reports “...Dr Chirag Shah, head of clinical operations at Raptim Research, emphasized the growing significance of RWE in modern drug development. He noted, ‘With regulatory agencies worldwide placing increasing emphasis on evidence-based research, it is imperative to streamline and scale RWE methodologies for more economical and efficient outcomes...India’s flexible and cost-effective regulatory environment and data management capabilities can complement Europe’s structured frameworks, ensuring faster and more reliable outcomes,’ he added.” Full
Press Releases
D-CARE Study Finds No Differences Between Dementia Care Approaches on Patient Behavioral Symptoms or Caregiver Strain
(1/29, UCLA Health Press Release) “...Funded by the Patient-Centered Outcomes Research Institute and the National Institute on Aging, the D-CARE study aimed to compare the effectiveness of two established dementia care approaches to each other and to usual care. It comprised 2,176 persons with dementia and their caregivers and was conducted from June 2019 to August 2023.” Full
Thousands of People with a Severe Dust Mite Allergy Are Set to Benefit from Life-Changing Treatment
(1/30, NICE Press Release) “Optimised final draft guidance published today recommends 12 SQ-HDM SLIT, also known as Acarizax and made by ALK-Abello, as an option for treating persistent moderate to severe house dust mite allergic rhinitis in people between 12 and 65-years-old.” Full
UK Patients Enabled Access to Transformative New Medicines in Shortest Time Possible via New, Integrated Innovative Licensing and Access Pathway
(1/30, Medicines and Healthcare Products Regulatory Agency Press Release) “...It is the only example globally of an end-to-end access pathway, where a medicine developer can work collaboratively with the national health system, the regulator, and health technology assessment bodies from the early stages of clinical development.” Full
Journals
Comparative Effectiveness, Safety and Persistence of Ocrelizumab Versus Natalizumab in Multiple Sclerosis: A Real-World, Multi-Center, Propensity Score-Matched Study
Elena Barbuti, et al.
January 28, 2025, Neurotherapeutics
Association of Oral Triptans and Other Oral Migraine Treatments With Cardiovascular Outcomes in Patients With a History of Cardiovascular Conditions
David Dodick, et al.
January 28, 2025, medRxiv
The Impact of a Patient Advisory Board on a Clinical Comparative Effectiveness Trial: A Comparison of Patient and Researcher Perspectives
Laura M Kernan, et al.
January 30, 2025, Journal of Comparative Effectiveness Research
Decoding Pan-Cancer Treatment Outcomes Using Multimodal Real-World Data and Explainable Artificial Intelligence
Julius Keyl, et al.
January 30, 2025, Nature Cancer
Reports
NPC Responds to CMS’s Proposed Rule on Policy and Technical Changes to the Medicare Advantage Program and Medicare Prescription Drug Benefit Program for CY 2026
January 28, 2025