The US Food and Drug Administration (FDA) has issued a new draft guidance regarding the use of external control arms in clinical trials.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 […]
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 […]
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 […]
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, […]
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 […]
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 […]
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 & […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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, […]
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. […]
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 […]
Almost 1,000 US Drug Prices Hiked So Far in 2023
Drugmakers have raised the price of almost 1,000 prescription drugs this past month alone. These price hikes are anything but transparent for patients, as they are often obfuscated by complicated rebate schemes and reimbursement practices. Some lay the blame on upcoming provisions of the Inflation […]
Bristol Myers Reveals Positive Phase II Data for Leukemia CAR-T Cell Therapy Breyanzi
Bristol Myers Squibb has announced new clinical trial data for its leukemia CAR-T cell therapy Breyanzi. The data shows that the therapy has met its primary endpoint in the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL), beating standard care in complete […]
J&J and Legend’s CAR-T Therapy Better Than Standard Care in Phase III Trial
J&J and Legend Biotech have announced new results from their CARTITUDE-4 trial that shows their new CAR-T therapy Carvykti is more effective at treating multiple myeloma than standard care. The companies say that the therapy, which many predict to be an upcoming blockbuster, has achieved the […]
Tidepool Pancreas App Wins FDA Approval
The US Food and Drug Administration (FDA) has approved the Tidepool “artificial pancreas” app. The prescription-only software connects continuous glucose monitors (CGMs) and insulin pumps to automate insulin delivery and blood sugar management in patients with Type I diabetes. The app will work with […]
Using the UK’s Innovative Medicines Fund to Accelerate Rare Disease Drug Development and Access
The UK’s Innovative Medicines Fund (IMF) was started in collaboration with the NHS England and National Institute for Health and Care Excellence (NICE) to provide novel medicines with unresolved uncertainties to patients with rare non-cancer diseases that have little treatment options. In doing so, […]
US Senators Blast Moderna for COVID Vaccine Price Hikes
Moderna is drawing heat from some US lawmakers and political leaders over its plans to spike prices of its COVID-19 vaccine to $110-130 per shot. The planned price hike, which is higher than the original price increases floated last fall, was lambasted by senators like Bernie Sanders (I-VT), […]
EMA Committee Announces Orphan Drug Application Changes to Improve Access to Rare Eye Disease Medications
Policies regarding orphan drug designations for a group of rare genetic eye diseases called inherited retinal dystrophies are changing, according to the European Medicines Agency (EMA). The changes would target terminology regarding the categories of disorders that are covered under the orphan drug […]
US Sen. Warren Calls for March-In Rights for Prostate Cancer Drug
Elizabeth Warren (D-MA) and 25 other US senators wrote a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra requesting that the agency implements march-in rights for Astellas’ and Pfizer’s prostate cancer drug Xtandi. This would allow the federal government to take […]
Sonoma Pharma Seals Pricing and Distribution Arrangement, Spiking Share Prices
Sonoma Pharmaceuticals has announced that it has locked in a distribution and pricing deal with the Defense Logistics Agency. The announcement of the deal, which covers its Microcyn Rx products, was followed by Sonoma’s shares jumping in price by 82%. Products included in the deal are used for wound […]
Millions of Medicaid Beneficiaries Likely to Lose Coverage When Continuous Enrollment Ends
Medicaid enrollees must reapply every year in a complicated process fraught with hidden pitfalls that could sink one’s coverage. This process was suspended during the pandemic, but the provision’s end date of March 31st is fast approaching. As a result, millions of beneficiaries are set to lose […]
Talking Real-World Evidence with Healthcore’s Co-Founders Mark Cziraky and Marcus Wilson
As Healthcore gears up for their impending brand transition to Carelon Research in the coming months, co-founders Mark Cziraky and Marcus Wilson discussed their insights into the importance of high-quality real-world evidence (RWE) generation methods and why they founded the company. […]
New Venture Capital Firm Launches to Support Health Sciences Digitization
Cutting edge technology like big data analytics, artificial intelligence, and machine learning are poised to revolutionize life sciences and healthcare. Dimension, a new venture capital fund, has launched today in to support the digitization of life sciences. The fund is prepared to support new […]
