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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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, […]
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 […]
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 […]
FDA Releases Guidance on Utilizing Real-World Evidence for Pharmaceutical Regulatory Review Process
The FDA has published final draft guidance for pharmaceutical companies, indicating how they can use real-world evidence to support their applications during the regulatory review process for new treatments. The release aligns with the 21st Century Cures Act, which aims to expedite the development […]
Healthcare Data Market Forecasted to Triple by 2030 Amidst Real-World Evidence Boom
The mass digitization of healthcare records has created a wealth of clinical data assets, leading to a predicted 14.6% growth in the market through 2030, increasing its value from $4.6 billion to $13.6 billion. This growth is catalyzed by trends, including the widespread adoption of electronic […]
Medicare to Negotiate Prices for 10 High-Cost Drugs Under New Democratic Reform Law
Medicare will negotiate prices for ten high-cost drugs, including major diabetes medications and blood thinners, as part of a drug pricing reform law by Democrats. Here's what you need to know: The new prices will be announced in September 2024 and will take effect from January 2026. The […]
Medtronic’s Inceptiv System: A New Auto-Adjusting Spinal Cord Stimulator Receives EU Approval
Medtronic has developed a spinal cord stimulator called the Inceptiv system, which alleviates discomfort caused by movements shifting the position of standard systems. The system automatically adjusts to movements, removing the need for users to alter their therapy according to their actions. When […]
Aetion’s SURF Tool: Advancing Feasibility Assessment of Real-World Evidence in FDA Applications
Aetion®, a leader in real-world evidence (RWE) technology and analytics, has published 'SURF,' a tool intended to assist sponsors in assessing the feasibility of utilizing real-world data (RWD) to provide evidence supporting an effectiveness claim in a U.S. Food and Drug Administration (FDA) […]
Atropos Health Expands into Life Sciences Sector
Atropos Health, acclaimed for its Green Button Clinical Informatics Consult Service, is expanding into the life sciences sector. It will utilize its Evidence Platform for various life sciences applications, including AI innovations and evidence generation. A Life Science Advisory Board is […]
Microsoft and Epic Expand Partnership: Generative AI Integration in Healthcare to Alleviate Workforce Burnout and Staff Shortages
Microsoft and Epic are extending their partnership to incorporate AI technologies in the healthcare sector. This joint venture aims to address critical issues, including workforce burnout and staff shortages. Key areas of collaboration include the employment of conversational, ambient, and […]
Boehringer Ingelheim Files Lawsuit Against U.S. Government Over Medicare’s Drug Price Negotiation Power
Boehringer Ingelheim has filed a lawsuit against the U.S. government, arguing that Medicare's new power to negotiate drug prices is unconstitutional and forces pharmaceutical companies to adhere to unfairly imposed terms. The company joins Merck & Co, Bristol Myers Squibb, Astellas Pharma, and […]
Bruker to Acquire PhenomeX for $108M
Bruker Corporation is actively acquiring PhenomeX in a cash deal valued at $108 million. PhenomeX, a product of Berkeley Lights' acquisition of IsoPlexis, performs analysis on live biological function. This acquisition will allow Bruker to enter into single-cell research, boosting its spatial […]
Strategic Planning, Partnerships, and Compliance in Conflict Zones
Here's What You Need to Know: The PwC 25th Annual Global CEO Survey showed that geopolitical conflicts significantly threaten global growth, with 71% of CEOs saying they could inhibit business operations. Such conflicts can cause operating challenges for companies, particularly those […]
FDA Approves Ipsen’s Ultra-Rare Bone Disease Drug Sohonos
The Food and Drug Administration (FDA) has approved Ipsen Pharmaceuticals' Sohonos, a drug designed to treat fibrodysplasia ossificans progressiva (FOP), an ultra-rare bone disease. The drug reduces undesired bone formation in soft tissues and is slated for use in females over eight and males over […]
Genentech to Pay $158,208 for Environmental Violations
Genentech has agreed to pay a $158,208 fine to the U.S. Environmental Protection Agency (EPA) over environmental violations at its closed plant in South San Francisco. The violations discovered during a 2021 inspection include: Instances of improper disposal of hazardous materials. […]
Rising Biotech Stocks: Key Players to Monitor
10 Things You Need to Know: Biotech stocks continue to prosper long-term despite periodic fluctuations. In 2020, prominent biotech companies Pfizer and its partner BioNTech, Moderna, and Johnson & Johnson took the lead in launching COVID-19 vaccines. Investor's Business Daily's […]
Biopharma Companies Plan of Attack After COVID-19 Revenue Boom
The COVID era created new mass-market drugs and vaccines requiring substantial investments. However, investors and analysts urge companies to adapt their businesses as the focus shifts from pandemic to endemic status. Here's what you need to know: Many biopharma companies, including Pfizer, […]
Act4Biosimilars Advocacy Group Strives to Boost Global Adoption of Biosimilars by 2030
Act4Biosimilars, a global biosimilar advocacy initiative, aims to increase global adoption of biosimilars by at least 30 percentage points in over 30 countries by 2030. Here's what you need to know: Regulatory and policy hurdles and varied market dynamics cause disparities in biosimilar […]
