Drug, vaccine and medical device developers should publish all trial results according to the WHO, which says anything less skews R&D priorities and public healthcare investment.
In a sign that pharmaceutical regulators are merging their regulations further, Australia’s TGA (Therapeutic Goods Administration) is seeking to adopt 10 EMA (European Medicines Agency) guidelines on quality, biologics, clinical efficacy, safety, and...
The Society for Clinical Research Sites (SCRS), which represents the interests of clinical research sites, has announced a two-year partnership with North Carolina-based CRO PRA Health Sciences, while the group’s work with INC Research has resulted in...
Pharma has focused investment in lower risk specialty and orphan diseases to the detriment of 80% of the population, according to Sanofi’s head of R&D who calls for regulatory convergence to help reverse the trend.
Margaret Hamburg has called for increased regulatory co-operation to tackle the issues raised by globalisation of the drug industry as she steps down as Commissioner of the US FDA.
In another sign that early phase research demand is picking up, North Carolina-based CRO PRA Health Sciences (PRA) is increasing its Phase I clinical footprint in the US and Russia.
The WHO’s latest report on substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products has the organization divvying up certain responsibilities for controlling the fraudulent products between countries.
The Broad Institute of MIT and Harvard has entered into a partnership with Calico to study the biology and genetics of aging as part of early-stage drug discovery efforts.
More drugs for tropical diseases have been donated since the London declaration of 2012, but getting them to the remote communities is still a challenge according to a consortium led by the Liverpool School of Tropical Medicine (LSTM).
Celltrion has emphasised the savings Remsima ((inflizimab) could offer at a conference in Spain as partner Napp Pharmaceuticals prepares to extend the roll out of the Remicade biosimilar to the UK.
CRO Theorem Clinical Research and service provider Biomedical Systems have formed a strategic partnership to expand the type of services available to their clients worldwide.
CRO consolidation continues with Rockville, MD-based Accelovance expanding its footprint into Europe with the acquisition of Cambridge, UK-based Altair Clinical.
The US Food and Drug Administration (FDA) is requesting a budget of $4.9bn for fiscal year (FY) 2016 – a 9% increase over the enacted budget for FY 2015.
Draft guidance distinguishing wearable medical devices from ‘general wellness’ devices could slow pharma’s adoption of such data in the short-term, according to an analyst.
Big pharma and CROs looking to exploit wearable technology in clinical trials will need to overcome reliability and regulatory problems, says an expert.
German CRO Evotec AG and Padlock Therapeutics have successfully completed an initial goal in developing inhibitors of protein-arginine deiminases (PADs) and have further extended their collaboration through March 2017.
Aurobindo Pharma has recalled one lot of Gabapentin for the treatment of epilepsy and postherpetic neuralgia (pain after shingles), after it was found to contain empty capsules.
In the future pharma will be reliant on technology, says physician-scientist Daniel Kraft, who warns that companies which fail to innovate risk being left behind.
US academics have licensed a mobile clean room design from Xoma for a vaccine and medical countermeasure plant being built in Texas as part of an HHS-funded project.
At the request of the European Commission, the EMA (European Medicines Agency) announced Friday that it would open a review into findings that GVK Biosciences’ site in Hyderabad, India falsified electrocardiograms in all nine clinical trials evaluated.
The rarity of medical research reanalysis and the extent to which reanalysis changes the original findings has two physicians calling for more transparency in an editorial in this month’s JAMA (Journal of the American Medical Association).
WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for clinical research, announced today it has acquired New England Independent Review Board (IRB).
GMP failures at an aseptic plant owned by SCM Pharma are part of a wider industry trend affecting several sterile sites in the UK, according to the ex-owner of the CDMO.
AmerisourceBergen has reported “outstanding operational and financial performance” for the third quarter 2014, and is set to pass the $100bn revenue mark for the fiscal year.
UK-based CRO Chiltern has agreed to acquire Ockham, a North Carolina-based full-service CRO, and the combined company will now compete with mid-sized CROs. Financial terms of the acquisition were not announced.
CRO Parexel has shifted its attention overseas with the acquisition of Atlas Medical Services, a provider of clinical research services in Turkey, the Middle East, and North Africa.
Small biotechs thinking of outsourcing should carefully weigh up the pros and cons say industry experts, who warn that for firms that do contract out clinical development choosing the right CRO is vital.
Medpace Laboratories, Singapore will serve and support new and existing Medpace pharmaceutical clients conducting clinical research in the rapidly expanding Asia Pacific region.
The National Institute for Health Research (NIHR) Clinical Research Network, which provides more than £284m ($475m) a year to support the delivery of clinical research studies, has reconfigured to become 15 local clinical research networks across England.
Better data on the global burden of tick-borne illnesses may encourage profit driven drugmakers to spend their R&D budgets on much needed treatments says the WHO.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) will launch a scheme next month to allow doctors to prescribe medicines without a marketing authorisation to patients with life-threatening conditions.
As part of an effort to increase transparency, the EMA (European Medicines Agency) has published the first summary of a risk-management plan (RMP) of a newly authorised medicine.
WuXi PharmaTech is partnering with Pacific Biomarkers to gain access to its menu of validated biomarker assays to support WuXi's integrated clinical trial testing services.
Clinical research group Venn Life Sciences has acquired the rights to LabSkin (pictured), a human skin substitute that behaves like the real thing, from dermatology CRO Evocutis.
National prioritization, investments in healthcare infrastructure and building better epidemiological and cost databases could bring more innovative medicines to middle-income countries, according to an independent study conducted by Charles River Associates.
CRO Pharmaceutical Product Development (PPD) and the Charité – Universitätsmedizin hospital in Berlin are collaborating to increase the volume of clinical trials conducted in Germany.
Theorem Clinical Research has announced the formation of a strategic alliance with Decision Driver Analytics (DDA) to integrate health economics and outcomes research, predictive modeling and definitive analysis to maximize return on investment for pharmaceutical...
The National Institutes of Health and 10 pharmaceutical companies have launched a partnership to transform the current model for identifying and validating promising biological targets for Type 2 diabetes, Alzheimer’s disease, lupus and rheumatoid arthritis.
