Industry News, Content and Resources
Implementing Diversity Action Plans in Clinical Trials: Navigating FDA Requirements and Enhancing Inclusivity
In April 2022, the FDA mandated that all Phase 3 and pivotal studies include a Diversity Action Plan (DAP) to ensure the representation of historically underrepresented populations in clinical trials. This requirement, codified in the Food and Drug Omnibus Reform Act of 2022, emphasizes the need [...]
Global Angiography Catheter Market: Surge in Demand Driven by Minimally Invasive Procedures and Cardiovascular Disease Prevalence
The global angiography catheter market, valued at $1.57 billion in 2024, is expected to grow at a 6.9% CAGR to reach $3.05 billion by 2034. This growth is driven by the increasing demand for minimally invasive procedures and the rising prevalence of cardiovascular diseases. Angiography catheters [...]
AbbVie Expands Neuroscience Portfolio with $8.7 Billion Acquisition of Cerevel Therapeutics
AbbVie has announced plans to acquire Cerevel Therapeutics, a neuroscience drugmaker, for $8.7 billion, marking its third and fourth largest biopharma M&A deals of 2023. This move comes shortly after AbbVie's $10.1 billion acquisition of ImmunoGen. The deal, priced at $45 per share in cash, saw [...]
FDA Gives First Approval for Novartis’ Iptacopan, a Revolutionary Oral Treatment for Rare Blood Disorder PNH
Novartis has received FDA approval for iptacopan, an innovative oral treatment for paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder. Marketed as Fabhalta, it's the first oral monotherapy for PNH, a disease affecting 10-20 per million globally. Iptacopan, lauded for its potential as a "pipeline in [...]
Exploring the Potential and Challenges of mRNA Technology in Revolutionizing Flu Vaccines
The article discusses the potential of mRNA technology, popularized during the COVID-19 pandemic, in revolutionizing flu vaccines. Traditional flu vaccines, often produced in hen’s eggs, could see a significant change with mRNA technology, with pharmaceutical giants like Pfizer, Moderna, GSK, and Sanofi exploring this avenue. This [...]
Navigating Pharmaceutical Sales with Next Best Action 2.0: A Data-Driven Approach
In the ever-evolving pharmaceutical business, the Next Best Action (NBA) approach has emerged as a crucial strategy for connecting with healthcare professionals and closing sales effectively. Initially, the NBA relied on predefined rules triggering specific responses, a method that often led to disregarded recommendations due to [...]
Consolidation of US Hospitals Leads to Increased Profits but Not Improved Care Quality, Study Finds
The consolidation of US hospitals increased between 2000 and 2020, with multi-unit hospital systems now owning 81% of hospital bed capacity, up from 58%. A study of 101 independent hospitals acquired by hospital systems in 20 states found that each hospital's operating profit rose by about [...]
UK Biobank Releases Groundbreaking Dataset from Whole Genome Sequencing of 500,000 Participants, Poised to Transform Medical Research
UK Biobank has unveiled a comprehensive dataset from genome sequencing of 500,000 participants, marking a milestone expected to revolutionize medical research fields. This private dataset, developed over five years and with an investment of over £200 million, is accessible to approved researchers internationally. The inclusion of [...]
Samsung Bioepis Set to Launch Stelara Biosimilar in 2025 Amid Challenges for Medicare Price Negotiation Exemption
Samsung Bioepis recently finalized an agreement allowing its Stelara biosimilar, SB17, to launch in February 2025. This move introduces competition against Johnson & Johnson's (J&J) successful anti-inflammatory drug, Stelara. However, this competition is not expected to be substantial enough to exclude Stelara from Medicare price negotiations [...]
Trump Revives ACA Debate, Faces Pushback Amid Biden’s Healthcare Emphasis
Donald Trump has recently reignited the debate over the Affordable Care Act (ACA), also known as Obamacare, despite the quieting down of Republican efforts to repeal the law in recent years. In a post on Truth Social, Trump criticized the ACA, claiming it to be costly [...]
AbbVie Expands Oncology Footprint with $10.1 Billion Acquisition of ImmunoGen
AbbVie, a pharmaceutical giant, announced its plan to acquire ImmunoGen, a clinical-stage biotech company specializing in antibody-drug conjugates (ADCs), for $10.1 billion. The key attraction of this acquisition is Elahere, an innovative ADC approved for treating platinum-resistant ovarian cancer. Elahere received accelerated approval from the FDA [...]
Balancing Public Health and Environmental Sustainability: Insights from the Unitaid Report
The recent Unitaid report highlights a complex issue in climate change: the significant environmental impact of essential public health items crucial for saving lives. These items, such as mosquito nets, pills, and rapid tests, contribute about 3.5 megatons of greenhouse gases annually, surpassing Geneva's total emissions. [...]
Harvard Researchers Urge Removal of Single Orphan Drug Exemption in Inflation Reduction Act
Biopharma companies are protesting the Inflation Reduction Act's (IRA) pricing negotiations for drugs with multiple orphan designations. Harvard researchers are urging Congress to remove the exemption for medications with a single orphan designation. According to a JAMA Internal Medicine paper, eliminating this exemption could save billions [...]
Gilead Sciences’ Kite Pharma Announces Workforce Reduction and Strategy Shift Amid FDA Review
Gilead Sciences' Kite Pharma is reducing its workforce by approximately 7% as part of a business strategy revision. The restructuring focuses on aligning with strategic priorities, leading to team reorganizations and eliminating roles not aligned with these goals. Despite creating around 90 new positions, the net [...]
Pioneering the Path for FDA Approval of Gender-Affirming Hormone Therapies: The Research Institute for Gender Therapeutics’ Groundbreaking Initiative
The Research Institute for Gender Therapeutics (RIGT), a nonprofit organization, is pioneering research to gain FDA approval for the use of estrogen as a gender-affirming treatment for transgender and gender-diverse patients. Historically, hormone replacement therapies like estrogen have been approved for cisgender patients, such as menopausal [...]