A new West Health-Gallup poll taken in June shows that 38% of American adults had to make changes to their life to afford healthcare. The kinds and degree of sacrifices varied significantly amongst demographics, with impacts felt harder by lower-income Americans. One-fifth of people making less than […]
Using Just-in-Time Clinical Trials to Address Disparities in Clinical Trial Representation
Finding and enrolling patients for clinical trials is one of the most difficult, time-consuming, and expensive parts of the drug development process. Ensuring that the patients represent the diversity of the population is even harder. In a new Targeted Oncology article, Kashyap Patel, MD, and […]
Syndicated Report: Real-world Evidence Pharma Market Size Stakeholders Focus on Growth Strategies up to 2030
A new research report from Stratagem Market Insights, entitled “Real-world Evidence Pharma Market,” breaks down the current growth dynamics of the real-world evidence (RWE) pharma market and projects it out from 2022 to 2030. The report includes in-depth profiles of all the major players and covers […]
Biden Signs Inflation Reduction Act
US President Biden signed the Democrat’s Inflation Reduction Act into law yesterday, August 16th. The sweeping partisan reconciliation bill includes drug pricing reforms that will allow Medicare to negotiate prices for a small set of expensive prescription drugs that will expand over the coming […]
1st Zantac Case Against GSK Dropped by Plaintiff
Joseph Bayer, the plaintiff in the first case surrounding GSK’s Zantac has voluntarily dismissed his case against the company, citing personal health reasons. Bayer sued GSK and several others for esophageal cancer he developed that he and his care team attributed to the drug. So far, he has gotten […]
Gilead Spends $455 Million for Rights to New Breast Cancer Drug in Asia
Hot off the heels of Gilead’s June approval for Troldelvy for metastatic triple-negative breast cancer (TNBC) drug in China, the company has agreed to a deal buying exclusive rights to sell the drug in Asia from the China-based Everest Medicines. This agreement gives Gilead global control of […]
US Drug Launch Prices Higher Than Ever in 2022
A Reuters analysis has found that US launch prices for new drugs are approaching record highs. The study found this year’s median annual price of 13 drugs recently approved by the Food and Drug Administration (FDA) for chronic conditions is $257,000, with seven other drugs reaching the $200,000+ […]
HHS inspector general: NIH failed to verify clinical trial results were reported on time
Most NIH-funded clinical trials with results due in 2019 and 2020 did not meet federal reporting requirements, the HHS inspector general’s office said in an audit released Tuesday. The audit revealed that of 72 intramural and extramural trials with results due in 2019 […]
Incoming ISPOR President Talks HEOR
Jan Elias Hansen, PhD, will soon take the reins as the ISPOR President for 2022-2023. In this month’s Value & Outcomes Spotlight, Hansen talks about her plans for the organization and her outlook on the field of health economics and outcomes research (HEOR). Her plan is to engage healthcare […]
Carlyle and Abingworth Make First Major Biotech Investment
Launch Therapeutics, a joint project between the Carlyle Group and its recently acquired Abingworth, is funding the Australian biotech Opthea to the tune of $170 million. The deal will also provide clinical, regulatory, and commercial services. The deal is intended to help develop and launch […]
Advancing Treatment for Immunological Diseases with Real-World Evidence and Data Analytics
Immune-mediated inflammatory diseases (IMIDs) are often difficult and expensive to treat, but new advances are being made with real-world evidence (RWE) and artificial intelligence (AI) by Jannen’s Immunology and R&D Data Science teams. Pulling real-world data (RWD) from a variety of sources, […]
Australian Mining Billionaire Leans Into Biotech
Billionaires have leaned hard into biotech investments in recent years, backing small and large companies alike. Andrew “Twiggy” Forrest has joined the gang with his quarter-billion-dollar venture fund Tenmile. Forrest, whose fortunes come from his Australian mining business, has also acquired two […]
Endpoints Webinar: How Merck is Building Biotech Labs of the Future – August 17th
The resources used by biotech labs often lag behind the new technological advances available to them. Digitalization, automation, robotics, and more could all help advance drug and device development if properly implemented. Unfortunately, dated systems often stand in the way of modernization. In a […]
AJMC Interview: Dr Amila Patel on Designing Digital Health Solutions With the Patient in Mind
Digital health solutions have expanded access to care for millions, but not all groups have gotten the benefits of these technologies. In a new AJMC interview, Amila Patel, PharmD, chief clinical officer, Navigating Cancer discusses research presented at this year's American Society of Clinical […]
Real-World Evidence and Real-world Data: Beyond Payer Decisionmaking
Although payer decision-making has been a key use of real-world evidence (RWE) and real-world data (RWD) in the healthcare space, there are far more avenues in which these resources can advance medicine. Agencies like the US Food and Drug Administration (FDA) are increasingly using RWE and RWD to […]
Analysts Suggest Impact of Drug Pricing Reforms Would be Limited
Despite a litany of complaints and concerns from the industry, the new US drug pricing reform passed by the Democrats would have a marginal impact on pharma, according to analysts from the Bank of America and UBS. The legislation will allow Medicare to set Part D prices for some medications, 10 by […]
Using Patient-Centered Digital Health Solutions to Improve Mental Health Outcomes
In recent years, digital health solutions have been developed for a variety of chronic conditions, but have yet to meet their promise. This “translation gap” represents a target for improving the state of digital health and bettering the health outcomes of patients. Mental healthcare, in particular, […]
Meeting Patients’ Needs – the Role of the Provider
Taking on a more holistic approach to care requires consideration of a patient’s social determinants of health (SDoH). Amongst these factors is whether the patient’s basic needs are being met. A recent survey of 75 provider systems found that most providers are considering SDoH, but these efforts […]
New MDCG Guidance on Conformity Assessment and Notified Bodies
The Medical Device Coordination Group (MDCG) has released a new guidance pertaining to conformity assessment and notified bodies. In part 1 of the guidance, the MDCG seeks to support the process of designating notified bodies in NANDO. In the second part, the guidance goes over the notification […]
Inflation is Impacting Healthcare Decisions of Nearly 40% of Americans
The rising cost of healthcare has been exacerbated by inflation, impacting the healthcare decisions of almost 40% of US residents. A newly published West Health/Gallup shows healthcare cost increases have caused a large swath of the population to delay or miss healthcare, cut expenses, and incur […]
Connecting Mental Healthcare with Primary Care to Improve Health Outcomes
Millions of people in the US who would benefit from mental healthcare are unable to do so due to a litany of barriers to access. Integrating primary care and mental healthcare could help lower barriers and get care to more patients. However, it will take a multipronged strategy from all stakeholders […]
Crest Digital Health Targets Bipolar Disorder with Digital Health Solution
Patients with bipolar disorder often face poor health outcomes, especially when treatment plans are followed inconsistently or discontinued. Crest Digital Therapeutics, founded by Stephen Hamm, seeks to improve outcomes for people with bipolar disorder with its software platform that helps keep […]
Endo Will File for Bankruptcy Due to Opioid Lawsuits “Imminently”
Endo International signaled on Tuesday, August 11th, that bankruptcy is in the company’s immediate future. The announcement comes as the company faces thousands of lawsuits related to its role in the US opioid epidemic. The suits center around its drug Opana ER, which was pulled from […]
Pharma Voice Woman of the Week: Miruna Sasu, President and CEO of COTA
On this week’s episode of the Woman of the Week by PharmaVoice podcast, host Taren Grom sits down with the CEO and president of COTA, Miruna Sasu. In the interview, Sasu talked about the power of real-world data (RWD) and real-world evidence (RWD) in driving future advances in oncology. When […]
Essential Terms for UK Quality Regulations Post-Brexit
Many biotechs are struggling with the uncertain state of quality regulations in the Post-Brexit UK. Understanding the new regulatory processes and requirements begins with understanding the key terms in a new MasterControl article, Joanna Blair breaks down the top 11 terms you need to know to […]
Pharma Preps Legal Strategy Against New US Drug Pricing Regulation
The US Senate’s newly passed drug pricing regulation will allow Medicare to cut the prices of a select number of drugs over the course of the decade. In response, pharma companies have begun prepping their legal objections to the rule. The industry will likely sue the Center for Medicare and […]
Webinar: Confronting Care Inequities in Hospital Medicine
Although awareness of health disparities among marginalized racial and ethnic groups has grown in recent years, simply understanding the problem does not fix it. In a new webinar hosted by Becker’s Hospital Review, Greg Johnson, MD, SFHM, CEO of hospital medicine and chief diversity officer at Sound […]
Pharma Marketing USA 2022 Article: Pharma Needs a Digital Reset Same as Above
Reaching the most important stakeholders in pharma, patients and their HCPs, requires breaking down operational silos and creating cross-functional teams. Doing so can help companies condense the science to actionable content that’s tailored for their audience. Building such teams starts with […]
Exploring the Process for the Inflation Reduction Act Drug Price Negotiations
The Democrats’ Inflation Reduction Act includes a provision to let the US government negotiate the prices of certain medications for Medicare recipients. If passed, Medicare would be able to negotiate the price of 10 drugs in 2026 and another 20 by 2030. The slate of drugs targetted would include […]
