An expert from the health tech company explains how AI, natural language processing, and other tools can improve pharmaceutical product safety reporting.
As complex drugs see little competition, the FDA will distribute guidelines to increase approvals of generic medicines for ‘economic stability’ and to bring affordable drugs to patients.
The US FDA has released draft guidance documents on gene therapy programmes, which “should help sponsors avoid expending time and resources on unproductive drug development efforts,” says expert.
Aurobindo Pharma Limited has received a Form 483 detailing two problems identified by US FDA inspectors who visited its Unit VI facility in in Chitkul Village, Andhra Pradesh, India.
Regulatory reviewers spend more time managing incoming data than on the drug evaluation process, says Instem which has inked a deal with WIL Research for its nonclinical IT systems.
Novasep has joined the growing number of manufacturers betting on the antibody drug conjugate (ADC) market with a €3m investment at its plant in Le Mans, France.
Thermo Fisher Scientific has launched a predictive assay that, it claims, can assess a drug candidate’s potential to cause liver damage earlier than traditional methods.
The USP has clarified its proposed revision to the labelling of injectable drug vials which states that ferrules and cap overseals can only have markings intended to prevent an imminent life-threatening situation.
Watson Pharmaceuticals has voluntarily withdrawn one lot of its arrhythmia drug propafenone HCl in the US after the tablets were found to contain slightly higher levels of the drug’s API.
A bill has been introduced to the US House of Representatives that would require pharmaceutical manufacturers pay a fee and have their facilities inspected more frequently.
in-PharmaTechnologist.com's round-up of developments in the pharmaceutical manufacturing space features news of a fire at MY Healthcare, Helsinn's FDA approval and a safety award for Wyeth.
Solvay Pharmaceuticals still believed it was on track for meeting
US regulatory deadlines for pancreatic insufficiency drugs despite
receiving an approvable letter for its own newly formulated drug
Creon.
A novel drug designed to prevent coronary heart disease has failed
a pivotal clinical trial although the developers are hopeful the
drug might still win approval.
Drug manufacturers are increasingly turning to specialised
providers of analytical services for the solid state
characterisation of their formulations, seeking answers to
processing issues, drug delivery challenges and even protecting...
Using human tissue to test new drugs at earlier stages of
development can speed drugs to market faster, however, human tissue
remains a scarce resource for drug firms - something that US firm
Asterand has set out to change.
Contract manufacturer of sterile injectable products HollisterStier
has outlined plans to double its production capacity and laboratory
facilities, as it responds to increasing demand.
AssurX have launched a software process for document control, which
will enable pharmaceutical manufacturing companies to streamline
their approach to monitoring safety issues and overall quality
control efforts.
A US think tank, The Centre for Medicines in the Public Interest,
has released a new report projecting counterfeit drug sales to
reach $75 billion in 2010, a 92 per cent increase from 2005.
France's Valois will launch a new-generation dispensing pump that
should improve the accuracy of drug dosing into the nasal passages
at the Interpack show later this week, reports Phil Taylor.
Scientists may be fighting a losing battle to develop alternative
treatments to drug resistant pathogens, as research reveals the
evolution of drug resistance in bacteria is a trait that is
favoured through the process of natural...
Innercap Technologies has developed a new capsule drug delivery
system that makes it possible to combine two incompatible drug
compounds into a single dosage unit.
The EU and US move a small step closer to a harmonised regulatory
system with the first-ever collaboration on the review of
scientific data in an application to start a clinical trial.
