article thumbnail

FDA approves Amneal and Shilpa’s oncology product BORUZU

Pharmaceutical Technology

The US FDA has approved Amneal Pharmaceuticals and Shilpa Medicare’s oncology product BORUZU for subcutaneous administration.

article thumbnail

Are You Using Next-Gen Sequencing to inform AAV product and process quality? Here are 4 reasons you should

Bio Pharma Dive

Next-generation sequencing allows for critical insights into gene therapy products, which can help streamline and accelerate everything from process development and production to regulatory approval.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Dyadic expands Covid-19 licence with Rubic to bolster vaccine production in Africa

Pharmaceutical Technology

The now expanded agreement will enable Rubic to explore other therapeutic avenues in both the human and animal health product markets. The extension of the agreement beyond its original Covid-19 focus will accelerate development timelines, increase productivity, and lower manufacturing costs, according to Dyadic’s CEO Mark Emalfarb.

article thumbnail

Large Review Finds CBD Products Don’t Relieve Chronic Pain After All

AuroBlog - Aurous Healthcare Clinical Trials blog

Evidence does not support the use of cannabidiol (CBD) products as a treatment for chronic pain, a new review found.

article thumbnail

Commercial Drug Sourcing for Clinical Trials

Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others.

article thumbnail

NABL launches comprehensive training programme to enhance competence in reference material production

AuroBlog - Aurous Healthcare Clinical Trials blog

Click here Diagnostics + Font Resize – NABL launches comprehensive training programme to enhance competence in reference material production Shardul Nautiyal, […]

article thumbnail

Export of Ayush and herbal products registers 1.65% growth in first 10 months

AuroBlog - Aurous Healthcare Clinical Trials blog

Exports of Ayush (Ayurveda, Yoga, Naturopathy, Unani, Siddha, Sowa-Rigpa and Homoeopathy) drugs and herbal products from the country have reported 1.65 per cent growth during the first ten months of the current fiscal year. The growth in the month of January stood at 14.54

article thumbnail

Making the Case for Case Management for Cell and Gene Therapies

As demand for advanced therapies increases, so does the need for more specialized supply chain support, as these products have strict transportation and handling requirements.

article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight.