Complex Innovative Design
Decentralized Clinical Trials
European Medicines Agency
Hybrid Clinical Trials
In-Vitro Diagnostic Regulation
Outsourcing Clinical Trials
Real-World Evidence (RWE)
Research & Development
Research and Development
Robotic-Assisted Surgery (RAS)
RWE Decision Alert
Biotechs on the Rise
In the final article of our Biotech series, Joris Pezzini talks about the evolution of biotechs in the face of challenges and the drivers for future success.
Mandatory Patient-Focused Listening Sessions with CMS: What Manufacturers Need to Know
To learn about patient-focused listening sessions, their potential impact, and how manufacturers can prepare, we spoke with our experts.
What EU Companies Need to Know about the U.S. Inflation Reduction Act
We spoke with our inhouse experts to learn about the significance of the US Inflation Reduction Act for EU pharma and biotech companies.
The State of Market Access in Italy 2023
To learn about the state of market access in Italy today, we spoke with Giovanni Firenze, Director of Market Access Italy for Alira Health, who attended the recent 2023 Conferenza Nazionale(...)
Real World Evidence on the Rise
Driven by the increased use of RWE to inform regulatory and reimbursement decisions, the bar for RWE methodologies, the type of data collected, and the criteria for acceptance of the(...)
How to Choose the Right Analytical Methods for Biologics
Analytical method development is an important component of biologics development and the control of quality attributes that affect product performance and stability is critical to success.
Critical Quality Attributes for Drug Products
In this article, we will explore the importance of Critical Quality Attributes (CQAs) in the drug development lifecycle and why it is vital that your selected CDMO is capable of addressing them.
Latest from Alira Health
Pharma Company Succeeds in Adding Medicine to World Health Organization Essential Medicines List
A pharma company with a blood disorder treatment needed support to submit a value dossier to the WHO to add a medicine to the Essential Medicines List.
Pharma Company Extends to New Markets through Strategic Licensing Agreements
A Swedish pharma company saw a market opportunity to expand access to its proprietary product outside of the Nordics and sought support developing strategic licensing deals.
Pharma Develops e-Health Solution That Prioritizes Patients’ True Unmet Needs
A leading pharma company in the respiratory market sought support developing the right digital platform to expand their patient base and increase retention.
Connect with our biotech experts onsite in Barcelona at Bio-Europe Spring. How can we support your development plan and funding path?
XXII Conferenza Nazionale Sulla Farmaceutica
Meet Giovanni Firenze, Partner Consulting Italy, onsite in Catania and learn more about the impact of the new AIFA reform.
World EPA Congress Europe
Look for market access and pricing experts Ahmad Bechara and Andrea Mantovani representing Alira Health on the agenda at World EPA Congress.
Robotic-assisted Surgery in Orthopedic Procedures: Current Landscape and 2024 Outlook
What Comes After the mRNA Vaccines?
In the third episode of VacciTalks, we’ll discuss these new alternatives to mRNA vaccines and the promise they hold.
Medtech CDMO: Market and M&A Global Trends in 2024
This webinar replay investigates the current state of the global medtech CDMO industry and highlight Europe as a promising frontier for consolidation.
Alira Health Releases The 2024 Global Medtech Contract Manufacturing Report
Alira Health announced the release of the 2024 Global Medtech Contract Manufacturing Report. This report offers a comprehensive analysis of trends in the global medtech contract manufacturing(...)
Alira Health Advises Aesculapius Farmaceutici Srl in Its Acquisition by Ceres Pharma NV
We are pleased to have represented as transaction advisor Aesculapius, a leading Italian pharmaceutical company active in the development and distribution of prescription drugs, OTC(...)
Alira Health Releases Global Report on Robotic-Assisted Surgery (RAS) in Orthopedic Procedures
New analysis reveals the RAS in Orthopedics market is anticipated to grow 10% annually over the next five years, reaching more than 2.5 million procedures in the EU, UK and US.
The 2024 Global Medtech Contract Manufacturing Report
Discover the trends in the world of medical device CDMOs and their meaning for the industry in 2024 and beyond.
FDA Approves GAMMAGARD LIQUID Based on Safety Data From an RWE Study
Food and Drug Administration (FDA) approves GAMMAGARD LIQUID based on safety data from a real-world evidence study.
UK HTA Recommends KANUMA in Pediatric Patients Based Partly on Comparative RWD
KANUMA underwent a recent appraisal by the UK's NICE for the treatment of Wolman disease in children aged two years and under.
Best Practices for Health Technology Assessment of Robotic Assisted Surgery
An expert panel developed seven best-practice recommendations for evaluating Robotics Assisted Surgical systems and here are the results.
Therapeutic IgG-Like Bispecific Antibodies: Modular Versatility and Manufacturing Challenges
Our experts conducted a deep evaluation of IgG-like bsAbs including general advantages and disadvantages compared with MAbs and more.
Immunoglobulin Fc-Fusion Proteins
Our experts published a series of articles in BioProcess International reviewing the state of the art of Fc – fusion proteins, including their structure and molecular design, manufacturing(...)