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Tag: European Medicines Agency

Europe’s Medicinal Cannabis Growth: Regulations & Perspectives

By: Juan Sebastian Chaves Gil Recently, there has been a notable increase in interest in medicinal cannabis in Europe, leading to regulatory changes in several...

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Strategies for non-viral vectors targeting organs beyond the liver – Nature Nanotechnology

Zhang, Y.-N., Poon, W., Tavares, A. J., McGilvray, I. D. & Chan, W. C. W. Nanoparticle–liver interactions: cellular uptake and hepatobiliary elimination. J. Control....

CRISPR Gene Editing Had a Breakthrough Year—and It’s Only Getting Started

CRISPR ended 2023 with a bang.In November, the gene editing tool scored its first clinical approval for treating sickle cell anemia and beta-thalassemia in...

Boehringer Ingelheim signs up with IBM for AI therapy

Boehringer Ingelheim is the latest pharma company to turn to AI in the hunt for new treatments and therapies. The German company announced earlier this...

HPRA Guidance on Fees for Human Products: Medicines – RegDesk

The article provides an overview of the approach to be applied when calculating regulatory fees associated with registration...

Certainty, wine and haematology – Bone Marrow Transplantation

Pliny the ElderNatural Philosopher AD 23/79. In these matters the only certainty is that nothing is certain. Pliny the Elder was a man of...

PTC to lay off more staff following drug setback in Europe

Dive Brief: PTC Therapeutics on Friday announced its second round of layoffs this year in an attempt to preserve cash following a regulatory setback for its...

Generative AI-focused biotech startup Evozyne raises $81m

<!----> Deep learning biotech Evozyne has closed a Series B investment round worth $81m to advance its generative...

Navigating the Regulatory Maze: How PSC Biotech Lights the Way

Regulatory affairs (RA) is a profession in the life science industry that involves checking whether a...

What is a Data Monitoring Committee?

Clinical trials receive a lot of oversight from regulatory agencies, as well as independent committees reviewing different aspects of the trial. Depending on the...

CHMP to review Iveric Bio’s MAA for geographic atrophy treatment

Iveric Bio’s marketing authorisation application (MAA) for avacincaptad pegol (ACP) to treat a leading cause of blindness has been accepted for review by the...

FDA approval for Janssen’s prostate cancer treatment

The US FDA approval of Akeega (niraparib and abiraterone acetate) is based on positive results from the Phase III MAGNITUDE study. The US Food and...

How will this startup expand treatment options for a rare children’s cancer?

Nearly 50% of the children diagnosed with neuroblastoma are considered high-risk, where the tumor has spread, making surgery no longer a viable treatment option....

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