The US FDA has almost cleared a backlog of 4000 excipient formulations in its Inactive Ingredient Database (IID) and wants drugmakers to help ensure ongoing accuracy.
Researchers in sub-Saharan Africa have developed a plug-and-play lab-on-a-chip - a ‘nontraditional approach’ to a global problem, says AAPS plenary speaker.
Industry efforts to comply with new US track and trace rules are accelerating, but concerns remain about the quality of symbols used to mark products according to GS1 US.
The flexibility of clinical development for products on designated accelerated pathways is leading to at-risk investments in commercial manufacturing, say Pfizer and the FDA.
Thermo Fisher Scientific has provided Rutgers’ researchers with hot-melt extrusion tech to support development of continuous manufacturing for drug production.
Despite requiring more API, the price of inhaled insulin Afrezza has dropped below that of injected rapid-acting rivals says MannKind's CEO, reporting a resilient Q3.
inVentiv Health announced last week that it has closed its previously announced transaction agreement with the private equity firm, Advent International.
The new packaging solution is the first innovation to emerge from World Courier's Climate Optimization Research & Engineering (CORE) Labs, which it launched in 2015.
Addressing training methodologies will ‘go a long way’ in improving investigator satisfaction, according to a recent survey by Worldwide Clinical Trials.
Teleflex Medical Corp. has recalled devices used to deliver rescue therapies to people who have overdosed on opioids, following complaints of mechanism failure leading to a "public health crisis".
The US FDA has cleared Adaptimmune to start a trial of its fat cancer cell therapy, lifting the clinical hold imposed in August when the agency asked for more manufacturing data.
Saneca Pharma will invest in its manufacturing site in Slovakia to service a five-year agreement supplying the Menarini Group with controlled release pellets.
Analysts suggest a Trump presidency won’t have a material impact on contract research organizations – though a shake-up in trade policy could complicate the larger, global pharmaceutical industry.
Pfizer has earmarked two sites in the UK for closure, including an ex-Hospira aseptic plant in London it says would need ‘significant investment’ to remain open.
US public health programmes will use lower dose vaccines administered over longer periods from 2017 if President elect Donald Trump adheres to a plan he outlined last year.
Adents and Microsoft have introduced a new platform that allows contract manufacturing organizations (CMOs) to leverage data generated during the serialization process.
CiToxLAB has acquired AccelLAB, a preclinical medical device contract research organization (CRO) as the industry works to align the development of new drugs and medical devices.
CluePoints has launched a new solution to help support clinical data quality improvement as the industry looks to mitigate fraud – both unintentional and malicious.
CSSi LifeSciences has launched its fully integrated medical device contract research organization (CRO) as an alternative to “traditional ‘big-box’ CROs.”
Endo International has signed an agreement to sell its facility in Charlotte, North Carolina to an unnamed buyer that will take on 125 workers currently employed at the site.
Solithromycin’s benefits outweigh its risks but developer Cempra has not adequately characterized how likely the antibiotic is to cause liver damage according to a US FDA panel.
Exco InTouch has been granted a US patent for to its mobile health solutions, as the company works to establish its “leadership in the digital health field.”
Increasing demand for reduced particle loads in pharmaceutical containers has driven Datwyler to build a CHF 100m plant making elastomer components for injectable drug delivery systems.
Knudra Transgenics has licensed CRISPR-Cas9 genome editing patents from ERS Genomics to turn model organisms into ‘powerful platforms for discovery,’ says CSO.
The NORLUX Neuro-Oncology Laboratory has installed MR Solutions’ preclinical scanner to advance cancer research and translation to clinical applications.
