Molecular Templates’ clinical trial for MT-0169, its experimental multiple myeloma therapeutic, is back on, following the US Food and Drug Administration (FDA) lifting a partial hold. The hold was placed on the trial following two adverse events experienced by patients, who both recovered. The move […]
Addressing Barriers to Care in Rural America
Rural US residents face significant barriers to care that significantly worsen health outcomes. Addressing these barriers is a complex task due to the underlying reasons behind them. In a new Becker’s Hospital Review article, Karen Joynt-Maddox, MD, MPH, associate professor at the Washington […]
Pfizer’s RSV Vaccine Gets FDA Approval
The US Food and Drug Administration (FDA) has given approval for the use of Pfizer’s respiratory syncytial virus (RSV) vaccine in older adults. The move comes shortly after the agency approved another RSV vaccine from GSK. This sets up a marketplace standoff between the two, competing over a market […]
Over 500,000 Disenrolled from Medicaid After COVID-19 PHE Ends
Shortly following the end of the COVID-19 public health emergency, pandemic-era restrictions on Medicaid redetermination ended. In that time, over 500,000 people have been disenrolled, interrupting their coverage and impacting their access to healthcare. Some states have kicked off more […]
CMS Opens Up Coverage of Alzheimer’s Drugs
Once Lequembi, Easai’s amyloid-targeting Alzheimer's drug, is potentially approved by the US Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS) have announced they will expand coverage for the class of drugs. Previously, CMS only covered amyloid therapies in […]
US Congressional Research Service Asks When Pharma Can Challenge Drug Pricing Reform
The Congressional Research Service (CRS), a nonpartisan public policy research institute, released a report asking for more clarity on when lawsuits over upcoming Medicare drug pricing reform can commence. The report comes as industry groups also seek more transparency on time windows as they […]
Incorporating Value-Based Care into Nursing Homes with the Payvider Model
As nursing homes increasingly look for ways to incorporate value-based care into their practices, some are moving towards payvider models, wherein they partner with a Medicare Advantage insurer and play the roles of payer and provider together. A panel of experts spoke about this strategy in a […]
Eli Lilly Reaches $13.5 Settlement in Insulin Pricing Case
Eli Lilly has settled a case with patients using insulin, who accused the company and others of artificially inflating prices of the lifesaving drug. Lilly will pay out a total of $13.5 million and will maintain their $35 a month out-of-pocket price cap for four years at minimum. The company, which […]
Canadian Health Officials Tried to Hide Evidence Health Minister Stalled Drug Pricing Reform
Recently released emails show that Health Canada officials tried to hide a letter from Health Minister Jean-Yves Duclos to the Patented Medicines Prices Review Board (PMPRB), Canada’s independent drug pricing agency, asking them to delay drug pricing reform last year. The letter mirrored the pharma […]
Real World Data Study Finds Comprehensive Genomic Profiling Improves Cancer Outcomees
Real-world data (RWD) to be presented at this year’s upcoming American Society of Clinical Oncology’s Annual Meeting shows that comprehensive genomic profiling (CGP) improves cancer patients’ outcomes. The study, which covered 1,423 advanced cancer patients who received CGP from 2019 to 2021, showed […]
Patients Turning to Illegal Pharmacies for Essential Medications
US patients are increasingly turning to illegal pharmacies due to high prescription drug prices and shortages of essential medications. The issue has grown in recent years, catching the eyes of officials at the US Food and Drug Administration. It is especially concerning for the attention deficit […]
Real-World Data Backs Dolutegravir Combo Therapies for HIV
A real-world data study published in AIDS found that three two-drug dolutegravir combination therapies were as effective in managing HIV as commonly used three-drug treatment regimens. The study covered over 3,000 patients from 2015 and 2021 taking dolutegravir in combination with lamivudine, […]
Speaking with the Person Behind the Inflation Reduction Act Drug Price Negotiations
The US drug pricing reform in the Inflation Reduction Act was concocted by John Barkett of the Berkely Research Group. In a new interview, Politico’s Ben Leonard spoke to Barkett to talk about the process and the next steps for the Centers for Medicare and Medicaid Services (CMS). Barkett first […]
Expiration of Temporary Provisions Set to Change Up Insurance Coverage for People Under 65
COVID-era policies expanded access to Medicaid and Marketplace plans for millions of people in the US, resulting in the lowest rates of uninsured status ever. However, these policies are set to expire soon, resulting in many people under 65 losing their coverage. In a new Health Affairs article, […]
Part D Out-of-Pocket Prescription Drug Price Cap Will Help New Part D Recipients
A newly published study in JAMA Health Forum found that new Medicare Part D price caps on out-of-pocket prescription drug costs will help new beneficiaries switching from commercial plans. The study found that the $2000 price cap in the provision, included in the Inflation Reduction Act, would save […]
Accelerating and Improving Clinical Trials with Real-World Data
The ubiquitous adoption of electronic health records (EHR) has supported the explosion of real-world data (RWD) applications in clinical trials. RWD has the potential to accelerate and optimize clinical trials while expanding their reach. In a new Life Science Leader article, learn more about the […]
Looking at Real-World Data Supporting Durvalumab in NSCLC
In a new Targeted Oncology Case-Based Roundtable, clinicians discussed new real-world data (RWD) supporting the use of durvalumab in unresectable stage III non-small cell lung cancer (NSCLC). The clinicians discussed their use of the immunotherapy, noting that most of them continued the treatment […]
US FDA Fast Tracks Antithrombotic from BMS and J&J
Johnson & Johnson and Bristol Meyer’s Squibb’s (BMS’s) antithrombotic milvexian has been fast tracked by the US Food and Drug Administration for three indications, according to the companies. The drug received the designation for the drug for stroke, atrial fibrillation, and acute coronary […]
US FDA Approves Paxlovid for High-Risk Adults
The US Food and Drug Administration (FDA) approved Pfizer’s Paxlovid for patients at high risk of severe COVID-19 this week. The move is based on a randomized clinical trial that found that unvaccinated patients who had not been infected by COVID-19 before were 86% less likely to be hospitalized if […]
India’s NPPA Cuts Off-Patent Drug Ceiling Prices by Half
The National Pharmaceutical Pricing Authority (NPPA), India’s drug pricing agency, has announced it will cut the ceiling price of off-patent drugs by half to address profiteering in the pharmaceutical industry. The list of drugs covers much of the country’s National List of Essential Medicines […]
US CMS Announces New Strategy to Lower Medicaid Drug Prices
The US Centers for Medicare and Medicaid Services (CMS) has announced a new proposal to help lower prescription drug prices for Medicaid. The rule would establish a survey for drugmakers about drug manufacturing costs and would ensure that Medicaid payments for therapeutics, especially high-price […]
Yuhan Corp. Releases Real-World Data Supporting Leclaza in Lung Cancer
Researchers at Korea’s National Cancer Center have released new real-world data (RWD) supporting the use of Yuhan Corp’s Leclaza (lazertinib) in the treatment of a subset of non-small cell lung cancer (NSCLC). The study, basefd on data from 103 patients who used Leclaza as a […]
CMS Using Real-World Evidence in Medicare Drug Pricing Negotiations
The US Centers for Medicare and Medicaid Services (CMS) noted in a recent guidance that it will consider real-world data (RWD) and real-world evidence (RWE) as part of its upcoming Medicare drug pricing negotiations. However, the pharma industry is still awaiting clear guidance on the process, which […]
US House Members Call on FDA to Address Chemotherapy Shortages
A bipartisan group of US House representatives is calling on the Food and Drug Administration (FDA) to address ongoing shortages of key chemotherapy drugs. In a letter written by Debbie Dingell (D-MI) and Tim Wahlberg (R-MI), lawmakers highlight the current shortages of cisplatin and carboplatin and […]
US FDA Still Mulling Over Sarepta’s Duchenne’s Gene Therapy
The US Food and Drug Administration (FDA) has yet to make a call on Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy, although it appears to be leaning towards a limited “yes”. As a result, the agency has pushed back its decision from May 29th to June 22nd. Deliberations will […]
FDA’s CDER Looking Towards Quicker Accelerated Approval Withdrawal Approach
The US Food and Drug Omnibus Reform Act (FDORA) empowered the Center for Drug Evaluation and Research (CDER) with the ability to expedite the withdrawal of drugs that were granted accelerated approval if confirmatory trials are not successful. The new process, which has yet to be rolled out, will be […]
Value in Health Regional Affairs: Developing Generic Drugs for Rare Diseases
Orphan drug development in the US and EU languished for years due to high development costs and low sales until it was bolstered by legislative action. While this has brought powerful therapeutics to patients, these drugs are still prohibitively expensive. In a new Value in Health: Regional Issues […]
US FDA Approves Gene Therapy for “Butterfly Children”
The US Food and Drug Administration (FDA) has approved Krystal Biotech’s Vyjuvek, the first gene therapy for dystrophic epidermolyis bullosa (DEB), a rare disease that leaves affected patients, dubbed “butterfly children” with skin that damages extremely easily and heals poorly. The treatment, which […]
Biden Admin Proposes CMS Rule to Make Drug Manufacturing Costs Transparent
The Biden administration and the Centers for Medicare and Medicaid Services (CMS) have put forward a new rule intended to bolster drug price transparency by highlighting drug manufacturing and transportation costs. This would be performed via a variety of tools, including a drug price verification […]
Orphan Drug Status Plays into Drug Pricing
Orphan drugs, treatments for rare diseases with limited therapeutic options, are usually less profitable for pharma companies due to high development costs and small patient populations. However, orphan drug designation (ODD) offers monetary incentives to companies developing drugs for rare […]
