The White House has announced a plan by the Consumer Financial Protection Bureau (CFPB) to exclude medical debt from credit reports, impacting millions in the U.S. with unpaid medical bills. Experts support this move but suggest additional steps to reduce medical debt, including ending extreme […]
AstraZeneca and Daiichi Sankyo Plan Approval Filing for Breast Cancer Treatment Following Promising Trial Results
AstraZeneca and Daiichi Sankyo plan to seek approval for their breast cancer treatment datopotamab deruxtecan (Dato-DXd) following a clinical trial that revealed improved patient outcomes. The study included over 700 participants with inoperable or metastatic HR-positive, HER2-low, or negative […]
GA4GH Announces Ten New International Genomic Data Initiatives
The Global Alliance for Genomics and Health (GA4GH) has announced ten new international genomic data initiatives, bringing the total number of GA4GH Driver Projects to 28, involving 113 countries. These projects seek to implement GA4GH's genomic data standards in biomedical research and medicine and […]
Leveraging Companion Apps in Pharma: From Short-Term Profit to Long-Term Progress
The pharmaceutical industry often focuses on short-term progress, but patient companion apps offer significant medium- and long-term value, particularly in collecting and processing real-world data (RWD). While some companies have begun to tap into the potential benefits of digital apps, there is a […]
Risk of Long Covid Increases with Each COVID-19 Reinfection, Indicates Study
The coronavirus pandemic has prompted questions about reinfection and the risk of developing "long Covid" characterized by fatigue, brain fog, musculoskeletal pain, shortness of breath, gastrointestinal disorders, and dysautonomia, among other issues. Research led by Ziyad Al-Aly, chief of research […]
The Illusions of the U.S. Pharmaceutical Industry: Misdirection in Drug Pricing, Innovation, and Regulation
The U.S. biopharmaceutical industry uses subtle illusion techniques similar to magicians to distract Americans from truths about drug pricing, innovation, and regulation. These illusions include the assumption that reducing drug prices would harm research and innovation, which in reality it […]
California Legislature Approves Bills for 10,000 New Beds and Expanded Drug Addiction Treatment to Address Homelessness and Drug Crises
The California Legislature has approved two bills that aim to address the state's homelessness and drug crises. The bills support Governor Gavin Newsom's initiative to create 10,000 new beds and housing units and expand drug addiction treatment. The first bill (SB 326) amends the existing Mental […]
FDA Flags Manufacturing Shortfalls at Novo Nordisk’s North Carolina Plant, Impact on Drug Supply Uncertain
Novo Nordisk's shares have dropped after the FDA reported manufacturing deficiencies at the company's Clayton, North Carolina plant, which produces vital ingredient ingredients like semaglutide. From July 6 to 13, 2023, the FDA inspected the plant and criticized Novo for quality control lapses, […]
Polio Eradication Goals for 2023 Likely To Be Missed: Insights from the Independent Monitoring Board
According to a report by the polio program's Independent Monitoring Board, the Global Polio Eradication Initiative has likely failed to meet its 2023 goal to end polio transmission. Here's what you need to know... Only seven wild polio cases have been recorded this year in Afghanistan and […]
FDA Updates Guidelines on Using Single Clinical Investigation as Confirmatory Evidence for New Drug Approval
The FDA has issued a draft guide to clarify how evidence from a sole clinical investigation can be used as substantial evidence to approve new drugs. This draft guide is in continuation of guidance from 1998 and 2019 and specifies that the amount of confirmatory evidence required will depend on the […]
Biopharmaceutical Market Capitalization Rises in Q2 2023: Eli Lilly Takes the Lead
The market capitalization of the top 20 biopharmaceutical companies rose by 2.3% to $3.56tn in Q2 2023. Eli Lilly saw a 36.1% increase, making it the leading company in market capitalization, boosted by its diabetes drug Mounjaro and anticipated approval for its use in obesity treatment. […]
Gender-Affirming Care: The Challenges and Ethics of Randomized Controlled Trials
To offer gender-affirming care, such as hormone treatments, clinicians often need to manipulate medical coding systems and justify these treatments with randomized controlled trials (RCTs). The gold standard of medical research, RCTs involve assigning participants randomly to either receive a […]
U.S. FDA and Pharma Manufacturers Making Progress in Resolving Nationwide Cancer Drug Shortage
The U.S. FDA and pharma manufacturers are progressing in addressing the nationwide shortage of cancer drugs, with the supply of chemotherapy cisplatin nearing pre-shortage levels. Awareness of this shortage has much improved the collection of carboplatin as well. The FDA and pharma manufacturers […]
Alexion Pharmaceuticals Nears $125M Settlement in Class Action Lawsuit Over Alleged Unethical Sales Practices
A 2016 class action lawsuit against pharmaceutical company Alexion, which claimed that the company's unethical sales practices led to a decline in its stock price, might conclude after both parties proposed a $125 million settlement. The lawsuit represented shareholders who bought stocks between […]
Cognitive Ability Tied to COVID-19 Vaccination Rates
The study published in the Journal of Health Economics investigated a link between an individual's cognitive ability and their decision to receive the COVID-19 vaccination. The researchers found that people with higher cognitive abilities were likely to get vaccinated faster than those with lower […]
Pharmaceutical Companies Sue Biden Administration Over Alleged APA Violations in Medicare Drug Pricing Program
Pharmaceutical companies, including AstraZeneca and Boehringer Ingelheim, are suing the Biden Administration over its plan to lower Medicare drug prices. They allege the administration violated the Administrative Procedure Act (APA) by trying to implement the pricing program through agency guidance […]
Swoop Launches AI Tool for Medication Adherence Predictive Targeting
Swoop, a prominent provider of custom audiences for the pharmaceutical and life sciences industry, has launched the Predictive AI Adherence Targeting. This innovative targeting methodology uses machine learning and artificial intelligence to predict which patients and healthcare providers (HCPs) are […]
Adapting to Challenges and Opportunities: Medical Device Makers in a Tightening Economy
In today's tightening economy, medical device makers face more hurdles with the dwindling post-COVID-19 investment boom and a selective investment approach in healthcare. A fall in funding for digital health startups and slimming operating margins have painted a challenging picture. However, experts […]
AI-Enhanced Testing: Transforming the Landscape of Software Quality Assurance
Traditional test automation has limitations in replicating real-world user behavior and interactivity, which results in a need for an intelligent, dynamic approach to software testing. The leverage of AI in test automation presents a solution to this problem. AI-powered test automation faces […]
FDA Approves Updated Covid-19 Booster Shots from Pfizer/BioNTech and Moderna
The FDA has approved updated Covid-19 booster shots from Pfizer/BioNTech and Moderna for the fall season. The CDC's vaccine advisors will likely recommend the updated boosters soon, followed by a final decision on release by CDC Director Mandy Cohen. The safety, effectiveness, and manufacturing […]
AstraZeneca Inks $42M Deal with Verge Genomics for AI-Driven Drug Discovery in Rare Neurodegenerative Diseases
Verge Genomics, an AI-drug discovery biotech company, has entered into a $42 million deal with AstraZeneca to discover new treatments for rare neurodegenerative diseases. Over four years, Verge will collaborate with AstraZeneca's rare disease division, Alexion, and is eligible for a further $840 […]
Major Transformations Expected in Clinical Trials Industry with Projected Growth to USD 73.2 Billion by 2028
The clinical trials industry is predicted to evolve significantly, with advancements in technology like AI, machine learning, and blockchain that will significantly improve trial design, patient recruitment, and data analysis. Experts expect patient-centric approaches, decentralized trials, and […]
Seagen and Nurix Partner to Develop New Cancer Therapy, Deal Could Reach $3.4 Billion
Seattle-based biotech Seagen will partner with Nurix to develop degrader-antibody conjugates (DACs), a new type of cancer therapy. Seagen is paying $60 million upfront, and the deal could total up to $3.4 billion, including milestone payments. DACs deliver a molecule to cancer cells that mark […]
Medicare Price Negotiations for Drugs Begin in 2026: Eliquis Among Most Impacted
The Centers for Medicare & Medicaid Services (CMS) has disclosed a list of the initial ten drugs that will undergo Medicare price negotiations under the Inflation Reduction Act (IRA) starting from 2026, with the impact expected to be modest initially but gradually growing as more drugs are added […]
Astellas Drops Lawsuit Against HHS Following Exclusion of Xtandi from Drug Price Negotiation List
Astellas has canceled its lawsuit against the U.S. Department of Health and Human Services (HHS) after its prostate cancer drug, Xtandi, was not included in the initial list of drugs to face price negotiations in 2026. Astellas previously sued HHS over the Medicare Drug Price Negotiation Program, […]
IPG Health Debuts Diversity Initiative for Clinical Trials
IPG Health announced a new clinical trial diversity offering aimed at ensuring equitable representation across various aspects of diversity, including race, gender, age, and other intersectional groups in clinical trials. This offering is part of its EDI+You strategy, which seeks to provide […]
Transitioning to a Learning Healthcare System: The Importance of High-Quality Data and Real-World Evidence
Healthcare systems typically rely on data from small-scale, costly trials to make decisions about patient care, but this approach can be slow and often insufficient. However, with the introduction of real-world evidence, which has become more credible due to the rise of AI, robust health data, and […]
Healthcare Sector Experiences Fluctuating Fund Flows
Top 10 Things You Need to Know: Healthcare is often seen as a defensive sector due to its constant demand and some insulation from the economy. Despite this, the sector is down nearly 2% for the year, while the S&P 500 index has gained over 17%. The latest week saw investors pull a […]
Shortening Mental Health Treatment Waiting Times Could Save NHS Millions and Improve Patient Outcomes
What You Need to Know: Shortening treatment and waiting times for mental health conditions from 12 months to three could lead to financial savings for the NHS and improve treatment outcomes. The study, conducted by ieso Digital Health Ltd in partnership with Dorset HealthCare University NHS […]
Novo Nordisk’s Obesity Drugs Reshape Denmark’s Economy, Sparking Economic and Policy Debates
Novo Nordisk, a Danish firm initially known for producing diabetes drugs, has become highly influential on Denmark's economy due to the remarkable success of its two obesity drugs, Ozempic and Wegovy. Their overseas sales surge led to lower interest rates in the country and contributed significantly […]
