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The US FDA has released draft guidance documents on gene therapy programmes, which “should help sponsors avoid expending time and resources on unproductive drug development efforts,” says expert.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.
Pulmatrix Inc has extended its IP portfolio with a European patent for its particle-based drug delivery technology.
Arch Biopartners has selected Catalent to carry out studies and make batches of its orphan drug candidate AB569 for upcoming clinical trials.
Recombinant albumin supplier Albumedix will help Hebei Changshan Biochem Pharma develop a once-a-week diabetes treatment.
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.
The US FDA says it requires a colour change of the painkiller patch Duragesic in order to reduce injury and death caused by accidental exposure.
Report from PCT Europe
Risk-based monitoring for clinical trials was a hot topic at this year’s PCT Europe thanks to recent draft guidances from the FDA and the EMA.
DaVita Clinical Research has opened a Phase I facility focussed on kidney research in a bid to meet a “growing demand” for renal trials.
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.
The FDA has published a 483 detailing some of the 400 customer complaints that led to it sending a warning letter to APP Pharmaceuticals.
The US FDA has published final guidance on the CMC data needed to support early phase trials of live biotherapeutics.
Flat Congress funding will make FDA more reliant on user fees
President Obama’s budget for 2013 projects FDA funding of $2.5bn (€1.9bn), flat year-on-year, but user fees will give it more cash.
K-V prompts FDA investigation into compounding pharmacies
The FDA is investigating compounding pharmacies’ Makena after K-V Pharmaceutical said they differ from approved forms.
United Drug looking for M&A as packaging demand grows
Contract generics packaging demand and possible acquisitions of up to €300m ($408m) will drive growth at United Drug, an analyst reports.
FDA registers Aptar sites for extractables testing services
Aptar Pharma is providing extractables measurement services after registering two of its sites as contract testing laboratories with the FDA.
Thermo rolls out predictive liver toxicity assay
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.
Batch variation has implications for developing world
Variation between drug batches in developing countries poses “serious clinical implications” and should be tackled by regulators.
USP revises vial labelling standard
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 recalls batch oversized arrhythmia drug
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.
Bill calls for more inspections funded by pharma fees
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.
Manufacturing facility news in brief
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 'still on path' for Creon
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
Nature undervalued in drug discovery
Mother nature still has the jump on major pharma firms when it
comes to designing therapeutic products, a new study suggests.
AtheroGenics rethink strategy for heart drug
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.
Seeing through formulation problems
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...
Human tissue worth more than diamonds
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.
HollisterStier doubles capacity and lab space
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 launches corporate compliance system
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
Fake drug sales 'could nearly double by 2010'
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.
Valois launches new generation nasal spray
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.
Evolvability -a factor in drug resistance?
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...
Combo pills made simple with capsule tech
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.
Closer EU/US ties
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.