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 navigate the current regulatory landscape to ensure compliance. To start, companies must know the importance of UKCA and CE markings.
US FDA Gives Quick Approval for First Low-HER2 Breast Cancer Drug
The US Food and Drug Administration (FDA) has approved Enhurtu, the first drug to treat metastatic or unresectable low-HER2 breast cancer, a recently defined category of the disease. The drug, developed by AstraZeneca and Daiichi Sankyo, received expedited approval from the agency, in part because of the potential for the breast cancer category, which covers over half of cases previously defined as HER2-negative.
EU Committee Supports New Roche and Eli Lilly Meds as Clovis’ Ovarian Cancer Drug is Rejected
The European Committee for Medicinal Products for Human Use (CHMP) has given the nod to Eli Lilly for its type 2 diabetes drug Mounjaro and Roche’s macular degeneration drug Vabysmo. Clovis’ Rubraca, a third-line treatment for ovarian cancer, was not reccomended by the committee based on the manufacturer’s request. The drugmaker had already voluntarily pulled the drug in the US due to data linking the drug to increased mortality risk.
ICER Announces Initiative to Develop Health Equity-Targeted HTA Practices
Health technology assessment (HTA) agencies are primarily focused on efficacy and safety of a therapeutic on a general population. A [...]
Bayer’s Kidney Disease Drug Kerendia Approved in China
Bayer has just earned approval in China for the use of its drug Kerendia (finerenone) in the treatment of chronic [...]
Bavarian Nordic’s RSV Vaccine Candidate Granted PRIME Eligibility
The PRIME scheme helps accelerate assessment by the European Medicines Agency for therapeutics that treat otherwise unmet medical needs. Bavarian [...]
FDA Will Present Draft Guidance on Real-World Evidence in Grand Rounds on June 22nd
The US Food and Drug Administration will unveil its highly anticipated draft guidance on real-world evidence this Friday, June 24th. [...]
ISPOR Publishes HTA Deliberative Process Guidance
ISPOR – The Professional Society for Health Economics and Outcomes Research has published a new guidance on deliberative processes for [...]
Fishawack Health Teams Up with Avalere to Expand Market Access Offerings
The market access and health economics and outcomes research (HEOR) consulting experts at Fishawack Health have added Avalere Health to [...]
US Senate Advances its Version of Accelerated Approval Reforms
Right on the heels of similar legislation in the US House of Representatives, the Senate is pushing forward its version [...]
Cytel Announces Free Statistical Programming Ebook
When submitting data to the US Food and Drug Administration, maintaining a steady line of communications is essential. Frequent [...]
FDA Roundup – Week of May 10th
In the latest weekly FDA roundup, the agency has approved the immunomodulatory COVID-19 drug for use in hospitalized adult patients [...]
Report: HEOR Services Market 2022-2028
The health economics and outcomes (HEOR) research market has seen a massive expansion in recent years, and it appears this [...]
ISPOR Short Course: Market Access & Value Assessment of Medical Devices
Achieving market access for medical devices requires a nuanced understanding of the value assessment processes of health technology assessment (HTA) [...]
Webinar: Lessons Learned from Inspections and Audits During COVID-19
While the efforts and procedures of many regulatory bodies ground to a halt during the COVID-19 pandemic, the US Food [...]
Biogen Alzheimer’s Drug Pulled from European Application Process
Following a rocky series of setbacks in Europe and abroad, Biogen has backed out of the application process in Europe [...]
What can Europeans learn from Canada for the upcoming EU joint HTA, Gabriel Tremblay?
EU joint HTA will become reality in the next few years as communicated recently by the European Commission. However, applicability [...]
Value, Pricing, and Access in the New Healthcare Landscape
Healthcare is moving towards a new model, wherein digital technology, data analytics, and artificial intelligence are seamlessly integrated with traditional [...]
ISPOR 2022: Short Morning Course Sessions
Five short course morning sessions are being offered at ISPOR 2022 on Sunday, May 15th. The courses span a range [...]
Evidence Generation for Patient-Centered Health Technology Assessment
Health technology assessments are increasingly shifting from payer-focused analyses towards a more patient-centered approach. However, understanding what value metrics patients [...]
ISPOR 2022 Plenary Session: HTA on the Run
Health Technology Assessment (HTA) agencies have accelerated their process in response to the COVID-19 pandemic. In a plenary session at [...]
FDA’s New Guidance on Real-World Data Spurs Questions from Pharma
Pharma and biotech companies have several questions for the FDA regarding the new guidance documents about real-world data (RWD) that [...]
The UK’s New Approach to Market Access: Innovative Licensing and Access Pathway
Brexit signaled a major shift in medicine regulation in the UK, with the Medicines and Healthcare Products Regulatory Agency (MHRA) [...]
Xcenda Explores the EU’s Transition To a Joint HTA Assessment Framework
The EU began its transition to a pan-European health technology assessment (HTA) framework this January. Xcenda covers this process in [...]
Preparing for UK Medical Device Regulations: 4 Ways to Get Ready
With new guidance from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for regulated medical devices, companies are facing [...]