Researchers studying chemical reactions in urine have created an adhesive gel for drug delivery applications that they say is cheaper and easier to make than hydrogel-based carriers.
The Swiss importer that supplied fake Harvoni to Israel has named the Indian manufacturer from which it bought the drug and is cooperating with an investigation say regulators.
Almac Group’s Diagnostics Business Unit has opened a companion diagnostic development facility, giving the company a US base to support further growth.
With the first deadline for the ICH Q3D guideline on elemental impurities just a few weeks away, pharma companies are still facing some uncertainty about how to comply with the requirements.
Theravectys has outlined a 1-year plan to fix GMP deficiencies at its Paris facility and said the current manufacturing ban will not delay its clinical programmes.
With 320m monthly active users, Twitter could potentially serve as a new, unexploited resource to stimulate interest and enrollment in clinical trials.
Swissmedic has warned hepatitis C sufferers not to buy Harvoni from unknown sources after fake versions of the Gilead drug imported by a Swiss trading company were found in Israel.
ANSM has banned Theravectys from manufacturing candidate vaccines and immunotherapies at its Paris facility until September after observing critical GMP deficiencies during an inspection last year.
Drugmakers seeking to stop “commercially confidential information” being made public in trial reports will need to demonstrate the likely economic harm publishing it would cause says the EMA.
One-third of clinical-trials results in the US go unreported, according to new figures published in the British Medical Journal underlining how far the drugs industry remains from full transparency.
Enabled-FIH programs integrate GMP manufacturing with clinical testing, which enables drug product manufacturing to occur in real-time prior to clinical dosing.
The larger the discount the more likely a US physician is to prescribe a biosimilar rather than an originator biologic according to the results of a survey.
The WHO hopes Syrian authorities will soon let it ship surgical supplies to Moadamiyeh after a consignment of antibiotics and painkillers was allowed into the besieged city.
DCAT Week, which will be March 14-17 in New York, is organized by the Drug, Chemical & Associated Technologies Association (DCAT), and brings together key players from across the industry.
Hackers trying to steal drug formulae for counterfeiters can wreak havoc says an IT expert advocating stronger security for networked pharmaceutical manufacturing facilities.
Sanofi will tap Japanese academics' personalised medicine knowhow under a new collaboration with the University of Tokyo's translational research initiative (TR).
Bial says BIA 10-2474 met safety and tolerability requirements for human trials, but the firm cannot rule the drug out as the cause of lesions in dogs in a preclinical study.
Indian drug and API importers can apply for licenses online through a new service launched by the Central Drugs Standards Control Organisation (CDSCO).
Potentially hazardous bio-waste generated at the UK National Biologics Manufacturing Centre (NBMC) in Darlington is being made safe using a bespoke system developed by Suncombe.
ScinoPharm Taiwan announced its unaudited financial results for fiscal year 2015, and with it, plans to expand its contract businesses through strategic acquisitions.
Bacterial resistance to ciproflaxin is spreading according to the European CDC which wants the drug industry to invest in development of alternatives to the "last resort" antibiotic.
Pharmakon Pharmaceuticals has recalled a batch of morphine after reports three infants reacted badly to the painkiller while being treated in hospital.
Multiple sclerosis patients taking Tysabri (natalizumab) who are deemed to be at high risk for the lethal infection PML should have regular brain scans according to the EMA.
Ennaid Therapeutics has announced it is developing therapeutic cures to help those that may become infected with the Zika Virus, and it may be available in less than four years.
The European Pharmacopoeia Commission (Ph. Eur.) has decided to recruit international experts to ensure the compendium evolves with the globalisation of the pharma industry.
Zika researchers are using animal models and epidemiological studies to try and determine if the virus causes birth defects and neurological disorders.
Silicon Biosystems Menarini and Macrogen announced they will form a partnership to provide clinical assays and new procedures for precision medicine in cancer.
China has pledged to review drugs for serious childhood diseases ahead of other meds if developers can show they have significant therapeutic advantages over current treatments.
Drug industry efforts to develop a Zika vaccine are accelerating but it will be at least 18 months until the first candidates are ready for trials according to the WHO.
