FDA Advisory Committee Recommends Rexulti for Alzheimer’s-Related Agitation
Agitation is a common symptom of Alzheimer’s disease, negatively impacting the quality of life for patients and their caregivers. An advisory committee for the US Food and Drug Administration (FDA) has given the nod to expand the indication of Takeda and Lundbeck’s Rexulti, a widely used atypical antipsychotic, to include the treatment Alzheimer’s disease-related agitation (AAD).
Making Naloxone OTC Doesn’t Go Far Enough
Last month, the US Food and Drug Administration (FDA) approved the over-the-counter (OTC) sale of naloxone, a drug commonly known as Narcan that reverses opioid overdoses instantly. The move was hailed by patient advocates, but many feel that OTC access is not enough to get the drug in the hands of those who need it. One key sticking point is the high cost per dose for name brand Narcan.
US Supreme Court Pauses Texas Judge’s Ruling to Revoke FDA Approval of Mifepristone
Following calls to act on a ruling from a Texas federal judge that would overturn the US Food and Drug Administration’s (FDA’s) approval of the abortion drug mifepristone, the Supreme Court has stepped in and placed a 5-day hold on the lower court’s decision. The temporary stay will last until Wednesday, April 19th.
Real-World Evidence Study Finds Cefiderocol Effective Against Antibiotic-Resistant Bacterial Infections
Shionogi & Co., Ltd. will present real-world evidence (RWE) showing that its antibiotic Fetcroja (cediferocol) is effective at treating infections caused by antimicrobial-resistant Gram-negative bacteria. The results, which will be shared at this week at the European Congress of Clinical Microbiology & Infectious Diseases.
Finch Ratings: Medicaid Disenrollment Set to Financially Impact Not-For-Profit Hospitals
A new analysis from Finch Ratings finds that non-profit hospitals’ bottom lines will be hurt by upcoming Medicaid disenrollment triggered by the imminent end of the COVID-19 public health emergency. Many patients going to not-for-profit hospitals were covered by Medicaid expansions. Since a large number of these patients will be disenrolled, Finch predicts that they will have to receive charity care that hospitals will not be paid for, hurting their revenue.
Real-World Evidence Studies Find Remdesivir Effective for Immunocompromised Patients with COVID-19
Gilead Sciences, manufacturers of Remdesivir, announced results from 2 real-world evidence (RWE) studies demonstrating the efficacy and safety of the drug in immunocompromised patients with COVID-19. The first study showed that the anti-viral medication reduced mortality significantly in patients living with cancer and all previous variants of COVID-19.
Real-World Data Shows Black People Face Higher Rates of Insomnia and Receive Poor Care
A growing body of research indicates that Black people in the US have significantly higher levels of sleep disorders like insomnia and sleep apnea than their white counterparts. Despite this, Black patients typically receive substandard care for sleep problems. A real-world data (RWD) study earlier this year found that only 6.2% of Black patients diagnosed with insomnia received medication for it, less than half the rate of white patients.
Cigna PBM Announces New Pricing Strategy
Cigna has announced a new pricing plan for its pharmacy benefit manager (PBM) arm that it promises will lead to increased transparency. The move comes as the PBM industry faces increasing public scrutiny over its lack of transparency and allegations of anti-competitive practices that drive up drug prices for patients and payers.
US FDA Shoots Down Eli Lilly’s Application for Ulcerative Colitis Drug
The US Food and Drug Administration (FDA) has declined to approve Eli Lilly’s ulcerative colitis drug mirikuzimab. The agency credits manufacturing issues for the decision, noting that the drugs efficacy and safety are not in question. A Lilly spokesperson said that they are working closely with the agency to address these problems and bring the drug to market.
Public Comments Closing for Medicare Drug Pricing Negotiations
As the window for public comments on the US Centers for Medicare and Medicaid Services’ (CMS’s) plan to negotiate Medicare drug prices comes to a close, Republican lawmakers and pharmaceutical companies seem to be in agreement with their complaints. A group of congress members from both the Senate and House argue that the plan will hurt patients, providers, and caregivers if implemented.
Challenges in Studying Long COVID with Real-World Data
Real-world data (RWD) has been used extensively throughout the COVID-19 pandemic, with significant data generated regarding long COVID, symptoms of the disease that persist after the initial infection. However, there are significant challenges that remain when implementing RWD in studying the chronic condition. In a newly published paper in Nature, authors identify three major points of improvement to better utilize RWD in long-COVID research.
Danco Laboratories and DOJ ask for US Supreme Court Action on Conflicting Mifepristone Rulings
Both the US Department of Justice (DOJ) and the mifepristone distributor Danco Laboratories have called upon the US Supreme Court to act quickly to hold back the effects of dueling federal court cases regarding the drug. The Fifth Circuit Court of Appeals temporarily paused last week’s ruling that mifepristone, a key drug used in the abortion pill, was inappropriately approved. Although mifepristone can stay on the market for now, expanded access to the drug would be cut, putting manufacturers and the FDA in conflict with another ruling last Friday.
US Appeals Court Temporarily Blocks Decision to Strike Down Mifepristone Approval
The US Fifth Circuit of Appeals issued a ruling that temporarily blocks last week’s federal court ruling overturning the approval of mifepristone, a key component for the abortion pill. The pause is temporary, and it may require the US Food and Drug Administration (FDA) to revert to previous rules regarding its distribution.
CMS Publishes Proposal to Improve the Prior Authorization Process
The US Center for Medicare and Medicaid Services’ (CMS’s) Interoperability and Patient Access Final Rule ensures patient acccess to clinical data, adjucated claims, and other health information. The newly published Advancing Interoperabilty and Improving Prior Authorization Processes Proposed Rule would, if implemented, extend the prior rule with 5 key proposals targetting health data access and prior authorization.
US Insulin Pricing Looks Set to Change Across the Board
With new legislation and moves from major insulin producers, the US insulin market is set to see even more changes over the coming months. The process began with a $35 Medicare price cap on the drug enshrined in the Inflation Reduction Act, a cap mirrored shortly by Sanofi, Novo Nordisk, and Eli Lilly. Upcoming legislation may cap the price of the life-saving diabetes medication for all patients.
CMS Sets Date for Medicare Drug Price Negotiation Final Guidance for July
The US Centers for Medicare and Medicaid Services (CMS) will aim to release the final draft guidance on the upcoming Medicare drug pricing negotiations instantiated by the passage of the Inflation Reduction Act. The draft guidance was released last month and is currently open for comments. The agency, according to its administrator Chiquita Brooks-Lasure, has already begun talks with manufacturers.
Internal Tensions Brewing in Generics Industry Group
The Association for Accessible Medicines, a trade organization for drugmakers producing generics, is undergoing an internal riff that may jeopardize its lobbying power. This follows substantial financial losses and a series of high-profile layoffs. Group insiders lay part of the blame on the board of directors who they argue repeatedly fumbled key organizational decisions.
ICER Releases Draft Guidance Supporting Cost-Effectiveness of $2 Million Sickle Cell Gene Therapy
The Institute of Clinical and Economic Review (ICER) has issued a draft guidance supporting the use of two different gene therapies for sickle cell disease. The treatments, developed by Vertex and CRISPR Therapeutics, both run around $2 million per treatment, but ICER argues that the high price tag could be cost effective in some cases.
FDA Mulling Over Next Move Following Mifepristone Ruling
The US Food and Drug Administration’s authority to approve medications is on the line, following a Texas judge shooting down the decades-old approval of the abortion medication mifepristone. With this development, the agency is looking for ways to preserve its powers while keeping mifepristone on the market. The strategy will depend on an appeal at the Fifth Circuit tomorrow.
Drug Purchasing Group Sues Takeda Over Gout Drug Pay-For-Delay Deal
Takeda is once again in hot water over allegations it participated in a pay-for-delay deal, this time over its gout drug Colcrys. The plaintiffs, a group of drug distributors, claim that Takeda patent settlements with several generics manufacturers delayed the release of cheaper alternative, preventing price drops for the millenia-old drug.
Biotech Execs Weigh In on Mifepristone Ruling
In an amicus brief filed by a group of organizations, industry groups, and several biotech executives, writers argue that last week’s ruling overturning the US Food and Drug Administration’s (FDA’s) approval of mifepristone, a key component of the abortion pill, will “upend” the agency’s approval process for new drugs. This change, the authors warn, would harm patients and cut back research investments into drug development, as any drug may be pulled from market based on a judge’s whims.
Cerner Enviza Announces New US FDA Partnership for Drug Safety and Real-World Evidence AI Platform
The US Food and Drug Administration (FDA) has partnered with Cerner Enviza and John Snow Labs to produce artificial intelligence (AI) and machine learning (ML)-based tools to help parse and analyze unstructured real-world data (RWD) and generate real-world evidence related to drug safety. The two-year project will focus on the asthma drug montelukast.
Real-World Data Study Shows Biosimilar Rituximab for Rheumatoid Arthritis Safe and Effective
A new real-world data (RWD) study published in Rheumatology International found that patients with rheumatoid arthritis who switched from Roche’s biosimilar rituximab to Rixathon’s version of the biosimilar did not suffer any deterioration. Patients who had not taken any version of rituximab also saw similar benefits.
Pharma and FDA Wary of Dueling Texas and Washington Abortion Pill Rulings
Last week’s ruling in a US federal court that struck down the decades-old approval of mifepristone, a key drug in the abortion pill, has the US Food and Drug Administration (FDA) and the entire pharma industry on edge. The ruling, according to some legal experts, would undermine the agency’s ability to independently approve drugs based on scientific evidence. Another ruling last Friday ordered the FDA to continue providing the drug to 17 states.
Patient-Reported Data Collection to Grow Through Medicare Drug Pricing Negotiations
A recent guidance from the US Centers for Medicare and Medicaid Services (CMS) stated that patient experiences will be factored into the upcoming Medicare drug pricing negotiations. As a result, patient-reported data collection is set to grow significantly. However, significant uncertainty surrounds the process and meeting as of yet unset parameters for the datya.
