Real-World Data Study Backs Up Ide-cel CAR-T Therapy for Multiple Myeloma
A real-world data (RWD) study published in the Journal of Clinical Oncology found Celgene’s Abecma (ide-cel) CAR-T therapy was both safe and effective in the treatment of multiple myeloma. The data, taken from 196 patients, further back up the results from the Phase II KarMMa trial that helped support the approval of the therapy back in 2021.
Better Real-World Data Through the Cloud
Real-world data (RWD) and the real-world evidence (RWE) generated from it are increasingly used in clinical trials and healthcare decision-making. However, the utility of real-world datasets are held back by issues of data quality and interoperability. In a new Health Tech Magazine article, learn about how cloud computing can help improve RWD sources and advance clinical trials and more.
Siemens Gets FDA and EU Approval for High-Performance Tumor Imaging System
The EU and the US Food and Drug Administration have given approval for Seimens’ Hypersight computed tomography (CT) imaging system. The device, meant to be paired with Seimens Varian radiotherapy systems, produces large, high-contrast images of tumors and surrounding organs in seconds.
FDA Grants Orphan Drug Status to GSK’s Systemic Sclerosis Therapeutic
The US Food and Drug Administration has granted Orphan Drug Designation (ODD) to GSK’s Benlysta (belimumab). The designation applies to the use of Benylsta in treating the interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a rare autoimmune connective tissue disorder. The drug is currently approved for treating active lupus and lupus nephritis.
US Senate Finance Chair Wyden Asks CMS to Enact Inflation Rebates
Although the Inflation Reduction Act includes a provision that makes drugmakers provide rebates to US Centers for Medicare and Medicaid Services (CMS) if they hike prices at a rate exceeding inflation, no such penalties have yet been divvied out. This week, Sen. Ron Wyden (D-OR), Senate Finance Chair, penned a letter asking the head of CMS when the rebates would kick in, emphasizing the need for quick action as many drug prices jumped significantly higher than the current rate of inflation in the past month.
Visualizing the US Healthcare System Compared to Other Wealthy Nations
A newly published report from the Commonwealth Fund found that while the US spends the most on healthcare, it has the worst health outcomes amongst wealthy nations. In a new Advisory Board article, find 6 key charts that visualize the data, including “Changes in life expectancy over time,” “Healthcare spending per capita,” and “Avoidable deaths per 100,000 population over time.”
CMS Leaders Propose Universal Foundation for Quality Measures
The US Centers for Medicare and Medicaid Services (CMS) has several varying sets of quality measures with some degree of [...]
US FDA Unveils New Draft Guidance for Using External Control Arms
The US Food and Drug Administration (FDA) has issued a new draft guidance regarding the use of external control arms in clinical trials. The guidance comes as external controls are increasingly implemented in trials, owing to the growing acceptance or real-world evidence (RWE) in regulatory decision-making. This is especially the case in trials diseases that have small populations or those where holding back treatment would be potentially unethical.
Non-Teaching Hospitals Near Academic Medical Centers Have Better Health Outcomes
A recently published paper in JAMA Network Open found that non-teaching hospitals with academic medical centers (AMCs) in the surrounding area have better patient health outcomes than non-teaching hospitals with no nearby AMCs. The study looked at data covering 22 million hospitalizations of older patients with Medicare who got care at hospitals from 2015-2017 in the US.
US Spends the Most on Healthcare but Still Has Worst Outcomes of All Wealthy Nations
A new study from the Commonwealth Fund finds that the United States still has the worst health outcomes of all high-income nations despite spending the most on healthcare. The data came from the Organisation for Economic Cooperation and Development (OECD), covering high-income nations like the Netherlands, Japan, Germany, France, the UK, and others.
3 Key Barriers to AI Uptake in Pharma
Artificial intelligence (AI) plays a growing role in pharmaceutical development, but several barriers stand in the way of the technology reaching its full potential. A new Fast Company article lays out three key barriers that hold back implementation of AI, including siloed datasets and projects, the security weaknesses of centralized data pools, and the unintended bias that creeps into AI from training data.
FTC Reaches Agreement with GoodRx Over Patient Health Data Sharing
The US Federal Trade Commission has announced it reached an agreement with GoodRx over the company’s violation of its 2009 health breach notification rule. GoodRx has agreed to pay $1.5 million in fines, if approved by a federal court. The company lied to users about the privacy of their health data while secretly sharing it for advertising purposes.
Inflation Reduction Act Could’ve Saved Medicare Billions from 2018 to 2020
A recently published study in JAMA Health Forum investigated the potential impact of the drug pricing legislation within the US Democrat’s flagship Inflation Reduction Act had it been implemented in 2018. According to the analysis, had the legislation been in place at the time, Medicare would have saved $26.5B over 2018-2020.
Examining the Impact of Real-World Evidence in EMA Regulatory Decisions
Real-world data (RWD) and the real-world evidence (RWE) generated from it are increasingly used in health technology assessment (HTA) decisions from regulatory bodies worldwide, including the European Medicines Agency (EMA). In an open-access article published in Clinical Pharmacology & Therapeutics, learn more about how the EMA uses RWE in its decision-making.
Savings From Humira Biosimilars May Take Some Time to Kick In
With the introduction of Amgen’s Amjevita, AbbVie’s Humira loses its 2 decades of exclusivity. A slate of other Humira biosimilars are set to drop this year as well, with prices set to drop due to competition. However, the changes may be slow to take effect, as several factors are set to complicate the process of reimbursement and uptake.
Orphan Drugs Lead Specialty Medication FDA Approvals
Specialty medications currently lead the charts in terms of new drug approvals by the US Food and Drug Administration (FDA). On top of the heap are orphan drugs, treatments for rare diseases or those with no current therapeutics. In a new Pharmacy Practice News article, learn more about the orphan drugs in the approval pipeline for 2023.
First Humira Biosimilar Finally Hits Pharmacies with Two Price Points
After a 20-year monopoly on the market, AbbVie’s Humira has lost exclusivity with the entrance of Amgen’s biosimilar, Amjevita. This marks the beginning of the end of the $114 billion rheumatoid arthritis drug’s dominance, propped up by widely critiqued patent thicketing. The biosimilar will follow a dual pricing system that, at best, will be half the cost of brand name Humira.
Boehringer Ingelheim Reveals Positive Trial Results for Rare Psoriasis Therapeutic
Boehringer Ingelheim revealed new results from its Phase IIb EFFIOSAYIL 2 trial that shows its new antibody-based therapeutic Spevigo can prevent flare-ups in a rare and severe form of psoriasis, generalized postular psoriasis (GPP). The drug is the first treatment to be approved for the disabling and sometimes life-threatening condition.
Moderna and Pfizer COVID-19 Vaccine 4X Price Increase Worries UK and US Lawmakers
As the COVID-19 pandemic inches closer to its endemic phase, Moderna and Pfizer are gearing up to nearly quadruple the price of their mRNA-based vaccines. This has drawn concern and ire from politicians in the UK and US, with four members of the UK Parliament penning a letter urging them to reconsider due to the proposed price hike’s impact on the NHS.
FDA Approves Two New Treatments for Breast Cancer and Lymphoma
Eli Lilly and the Menarini Group have both gotten the nod from the US Food and Drug Administration (FDA) for their new cancer medications. Lilly’s therapeutic for relapsed or refractory mantle cell lymphoma, called Jaypirca, is only the fourth drug of its kind approved by the agency. It will cost $21,000 per month of treatment.
US Senator Elizabeth Warren Asks FTC to Investigate Two Pharma Mergers
US Senator Elizabeth Warren (D-MA) has expressed her concerns regarding two upcoming major pharma mergers, calling for the Federal Trade Commission (FTC) to investigate them. The two mergers are Amgen’s planned acquisition of Horizon Therapeutics for $28 billion and Indivior’s $145 million buyout of Opiant, the current owner of the opioid overdose rescue medication Narcan.
Veradigm Network EHR Data Now Available in OMOP CDM Data Standard
Veradigm Network, a major health IT company previously named Allscripts, has announced that its stores of electronic health record (EHR) data will be accessible in the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) data standard. This will make it easy for clients to generate and use real-world evidence (RWE) from over 170 million patients.
US Court of Appeals Sides with Pharma Over HHS on 340B Case
A US Court of Appeals ruled in favor of AstraZeneca, Novo Nordisk, and Sanofi in a case over the 340B Drug Pricing Program. The court decided that the companies could not be held responsible to provide the discounts mandated by the program at an unlimited number of pharmacies serving under-insured, lower-income communities.
Pharma Prepares for Bernie Sanders as US Senate Health Committee Chairman
US Senator Bernie Sanders (I-VT) has decried prescription drug prices and insurer practices throughout his political career. Now, as chairman of the Senate health committee, he will guide hearings and investigations into major pharma companies, pharmacy benefit managers (PBMs), and insurers. Industry sources say that companies are bracing themselves for the public image impact of these hearings, although they may face little actionable repercussions.
South Korean Pharma Industry Group Asks Government for Industry Steering Committee
According to the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), an industry group comprised of pharma companies based in South Korea, the nation should establish a steering committee helmed by industry leaders. The committee, according to KPBMA Chairman Won Hee-mok, would work with the government in policy-making regarding pharma and biotech products and services, as well as synchronizing strategies between health authorities and the industry.
