Marken’s Moscow-based depot has been granted a new pharmaceutical license from the Russian Federation, further extending the company’s capabilities in the area.
As clinical trials “continue to shift to emerging markets,” the translation company Welocalize has acquired Global Language Solutions (GLS) to further support its clients’ linguistic validation processes.
An Indian facility owned by Pfizer’s Hospira unit has been banned from supplying some drugs to the EU after MHRA inspectors found breaches of manufacturing regulations.
Fast-tracked Factor Xa inhibitor is being made for Portola by CMC Biologics and Lonza
Portola Pharmaceuticals says it was "caught off guard" after the US FDA raised manufacturing concerns in a complete response letter for its Factor Xa inhibitor, AndexXa.
Biologics developers need to be more vigilant about immunogenicity and manufacturing changes than small molecule drug manufacturers according to the EMA.
Roche is updating instructions for its Accu-Chek insulin pump after patients who failed to load the device correctly experienced hyperglycemic symptoms as a result of under dosing.
Biomanufacturing demand will drive revenues for Patheon according to an Evercore ISI analyst, who has predicted the newly-listed CDMO will strengthen its capabilities through M&A.
Purdue Pharma has joined the National Pharmaceutical Council (NPC), a health policy research organization working to advance good evidence and science.
World Courier is set to open a new Moscow, Russia-based investigational drug depot in August – and it will be nearly six times larger than the current depot.
Ashfield, a provider of outsourced healthcare services to pharmaceutical, device, and biotech companies, has announced a new international initiative, Ashfield Cares.
Pharmaceutical Product Development (PPD) is set to acquire evidence-based solutions provider Evidera, as the need for real-world data continues to grow.
The US FDA has criticised Chinese manufacturer Concept Products for not fixing cGMP violations observed by inspectors who visited its manufacturing site in Tianjin.
Pfizer unit Hospira has recalled one lot of the anaesthetic made at its facility in Rocky Mount, North Carolina after particulate matter was found in a vial of the drug.
Teva has recalled an injectable antibiotic that is one of only two products currently made at the Godollo, Hungary facility that was hit with a US import ban in May.
Pfizer has temporarily halted production at a former-Hospira aseptic plant in Chennai, India after regulators observed manufacturing issues during an inspection in June.
The US FDA has identified quality problems at a Smithfield, Rhode Island plant where Alexion makes the immunosuppressant Soliris (eculizumab) and other products.
The US FDA has ordered Adaptimmune to halt a trial of its candidate liposarcoma therapy and asked for more information about how the treatment is made.
As part of the company’s “site-centric” approach, inVentiv has expanded its relationship with the Society of Clinical Research Sites (SCRS) to elevate the “voice” of clinical sites.
The contract research organization (CRO) Velesco Pharma has opened a new laboratory in its Plymouth, MI-based facility to support an increased demand for materials management.
India has relaxed its study rules to let clinical investigators to take part in multiple drug trials and to allow smaller sites to be used for research.
The US Department of Agriculture (USDA) has fined Covance Research Products for violating animal care rules at its preclinical testing facility in Alice, Texas.
As part of a recent survey, 62% of respondents said they are more likely to engage a clinical research organization (CRO) partner for clinical research than they were five years ago.
Scientists at AstraZeneca’s former R&D site in Alderley Park will play a key role in researching antibiotics and the spread of resistance under an initiative launched by US President Barack Obama.
According a recent survey, while there is a disconnect between Sponsors and Providers in some areas, the industry as a whole agrees that there is room for improvement.
The US FDA says it identified “significant deviations” from manufacturing standards a facility in Denmark operated by allergy immunotherapy developer ALK-Abello (ALK).
The US FDA will not approve the candidate eye pain eye treatment Dextenza until developer Ocular Therapeutix addresses concerns about how the product is made.
The acquisition of Compass Research expands Bioclinica’s access to several specialized populations with neurodegenerative disorders and other diseases.
Micro Labs completes repeat studies and predicts drugs will be back on the market in autumn
Sandoz is repeating bioequivalence studies and Teva is withdrawing an antimalarial after the EMA recommended that drugs trialled by Semler Research Centre should be suspended.
The EMA is recommending the suspension of several medicines after inspections revealed flawed studies at the India-based contract research organization (CRO), Semler Research Centre.
European authorities want to revise the guidelines covering first-in-human studies in light of the French trial in which one man died and others were hospitalised earlier this year.
