The advent of low-cost, real-time technologies has made capturing real-world patient experiences easier than ever, allowing CROs to address concerns over end-use needs.
Researchers have developed an organ-on-a-chip model that will allow for preclinical testing in an environment analogous to the human gastrointestinal tract.
As a significant amount of drug discoveries occur outside of pharma companies, Elsevier has launched The Hive Project to promote innovation in the market – outside its walls.
Brammer Biopharmaceuticals and Florida Biologix have merged to create a cell and gene therapy biologics CDMO in preparation for a “tidal wave” of gene therapy products.
With more than 130 biotech and 20 pharmaceutical companies currently developing immuno-oncology (I/O) therapies, the global oncology market could reach $40bn by 2020, says Tufts.
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.
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.
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.
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.
Regenerative medicine developers now have a new supplier for mesenchymal stem cells (MSCs), the multipotent stromal cells derived from marrow and other tissues like muscle and dental pulp for tissue repair.
Last week another Google spinoff, Verily, released a video introducing itself to the world and its goal of using technology to create “a true picture of human health.”
The UK regulatory agency is recruiting for medical assessors, but with drug-device combinations, biologics and personalised medicines making the job more complex, do you have what it takes?
A UK government report on accelerated access to medicines proposes overhauling conditional licensing and reimbursement pathways to drive drug development.
Increasing pharma R&D spending is helping grow revenues for Medidata, which has boosted its cloud-based clinical technology through a partnership with Validic.
US and China-based CRO FMD K&L has expanded into Armenia with a new office to support clients’ needs in the region and grow the company’s business further in Europe.
CRO Pharmaceutical Product Development (PPD) has formalized relationships with eight investigator sites to create a pediatric investigator network (PIN) as part of efforts to speed trial startups, more predictably enroll patients and offer higher quality...
BioClinica has opened offices in London and Munich to provide its European clients with expanded clinical trial services including medical imaging, site training and support, and eClinical product lines.
Generic juggernaut Teva Pharmaceuticals has partnered with Microchips Biotech to use its implantable drug delivery device to improve outcomes for patients on chronic drug therapies.
Swiss CMO Lonza and Canada’s Octane Biotech have entered an exclusive technology evaluation of the Octane Cocoon cell production platform for personalized cell therapy manufacturing with the goal of a global deployment.
The Society for Clinical Research Sites (SCRS), a trade organization representing the interests of clinical research sites, has announced a two-year partnership with LabCorp’s Covance.
AstraZeneca has partnered with two Algerian companies, AHT Health and Hasnaoui Finance, to create a joint venture with the aim of building a new $125m manufacturing facility in Algeria.
The strategic partnership between Baltimore-based CMO Cognate BioServices and Florida-based Akron Biotechnology will offer clients a more complete package of cGMP manufacturing services and regulatory support to develop regenerative medicines and cell-based...
The EMA has released draft guidelines to aid the gene therapy developers, many of which it says are small companies not familiar with the regulatory environment.
Japan’s membership of the PIC/S international inspection and manufacturing scheme bodes well for patients in Japan and elsewhere according to the Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency (MHLW)
As M&A continues to ramp up for the pharma and biotech industry, communication and agility are two of the major keys for CROs to adapt to an acquisition, experts said Thursday at the Partnerships in Clinical Trials Conference in Boston.
