FDA to deactivate out-of-date drug listings in its database
In order keep up-to-date records and protect public health the FDA has announced it intends to deactivate out-of-date drug listings.
List view / Grid view
News
Letter highlights issues with US drug returns verification requirements
An open letter has underscored the challenges of return failure in the US drug supply chain, especially after the introduction of the Drug Supply Chain Security Act in November.
Voluntary recall issued for lidocaine cream and liquid gel products
Lidocaine topical cream and liquid gel products are being recalled as the lidocaine amount is higher than the label states.
Ebola clinical trial stopped early due to positive results
An Ebola clinical trial has been stopped early as Regeneron's REGN-EB3 therapy shows superiority to ZMapp in preventing Ebola deaths.
Amgen wins court patent ruling over Sandoz biosimilar
The US District Court has decided in favour of Amgen’s Enbrel, ruling over Sandoz’s Erelzi in a patent conflict.
US court rules in favour of Lilly in Alimta® patent lawsuit
The US District Court has ruled in favour of Eli Lilly in the Alimta patent lawsuit against Dr. Reddy's Laboratories and Hospira, Inc.
FDA grants Orphan Drug Designation to DYN101 treatment
A treatment for Centronuclear Myopathies has received Orphan Drug Designation from the FDA and will begin Phase I/II trials.
Clinical trial reporting is improved by professional medical writers
A new systematic review has shown that the speed and quality of clinical trial reports are improved by professional medical writers.
NICE releases draft guidance for using cannabis-based medicinal products
The NICE and NHS have announced their draft recommendations for the prescribed use of cannabis-based treatments.
FDA antibody biosimilar product approvals increase in 2019
2019 has seen a marked increase of antibody biosimilar product approvals in the first half of the year, according to a report.
Increasing number of diseases causing alopecia boosts treatment market
The global alopecia treatment market is projected to exhibit a CAGR of 4.9 percent from 2018–2026.
Thermally-stable TB vaccine developed using new technique
A new process developed by the University of Bath protects a TB antigen and a novel vaccine adjuvant from heat damage.
Pharma contract placements found to increase 250 percent
Pharma contract placement was found to increase by 250 percent compared to last year, according to figures from a recruitment firm.
Novartis could face legal action over Zolgensma application
The pharmaceutical company failed to inform the FDA of manipulated data when the gene therapy was under review and could face a legal battle.
UK pharma reputation falls due to Brexit and other factors
Less than one-third of UK patient groups rate the reputation of the pharma industry as good or excellent.
