CMO consolidation is resurrecting the ‘all-under-one-roof’ manufacturing model, but will firms fall into the same inefficiency pitfalls that drove pharma to outsource in the first place?
CROs, as well as sponsors, are receptive to, and plan to increase their use of ePRO (electronic patient reported outcomes), according to a survey published Monday from the Tufts Center for the Study of Drug Development.
India’s CDSCO (Central Drugs Standard Control Organization) has released a new draft bill that would amend the country’s landmark law governing pharmaceuticals from 1940.
Novacyl Wuxi Pharmaceutical has received a US FDA warning letter for failing to investigate the origin of metal particles found in drugs made at its paracetamol plant in China.
Sweden’s pharmaceutical regulator is pushing hard to make water pollution regulations a binding part of GMP, and says “embarrassed” European agencies are dragging their feet more than big pharma.
Regulatory reviewers spend more time managing incoming data than on the drug evaluation process, says Instem which has inked a deal with WIL Research for its nonclinical IT systems.
Cromos Pharma has launched a free or reduced cost trial model to help small and mid-sized drugmakers overcome the funding Catch-22 that can derail development efforts.
Indian regulators have accused a hospital of conducting unauthorised clinical trials of stem cell therapies and of charging patients who took part for the treatments.
GVK Biosciences has called marketing authorisation withdrawals by various European regulators “disproportionate,” arguing that ECG results at centre of data manipulation investigation have no bearing on safety.
Pharma companies have called on the Swedish government to prevent manufacturing going the way of R&D and leaving the country, after AstraZeneca closed its research in Lund in 2012.
Third-party logistics providers (3PLs) will have to report annually to the US FDA according to draft guidance published to help implement track and trace legislation.
Quintiles has been upgraded to stable by ratings agency Standard & Poor after a second stock offering and the consolidation of debt through a $300m securitisation facility.
INC Research has expanded its partnership with the Society for Clinical Research Sites (SCRS) through the end of 2015 to become the first organization to support SCRS' new member Scholarship Program as well as the first CRO to establish a Site Advocacy...
Cultural differences and broken promises are behind Indian GMP failures and acute generics shortages in the UK, according to one pharmaceutical distributor.
CRO industry group ACRO has welcomed a US NIH draft policy promoting use of a single IRB for site reviews per institute-backed multi-centre study, arguing that the approach would accelerate trials without compromising safety.
Third-party manufacturers anxious about Big Biopharma investments and downbeat industry reports can relax as experts concur “it’s a time of growth for biopharmaceutical outsourcing.”
Aid agencies in countries hardest hit by Ebola rely on manual, paper-based data collection according to one expert who says CDISC templates and mobile data capture would help.
The pace of recruitment is the biggest challenge in carrying out trials in Eastern Europe, says Mabion which has extended an agreement with local CRO Altiora for its biosimilar study.
Just in time for the holidays, GSK can ‘give thanks’ to the US Federal Trade Commission (FTC) which has approved the $7bn acquisition of Novartis’ vaccine business.
Recipharm will acquire a facility and add technologies including spray granulation and spray coating as part of a “truly strategic” collaboration with France-based Flamel Technologies.
The advent of Big Data in clinical trials will mean companies not using digital biomarkers are unlikely to exist by 2025, the President of cloud-based technology firm Medidata has warned.
Rottendorf is looking to break from being “the best kept secret in the CMO world” by targeting the thousands of virtual and SME pharma firms in the US, according to its CEO.
Dispatches from FT Global Pharmaceutical and Biotechnology conference, London
How can a pharma company invest in continuous manufacturing without bleeding money when it retreats from a local market? Pfizer’s answer is production pods it can roll out anywhere in the world via helicopter… and pack away again if a market turns.
Soon PPD and inVentiv will be the only privately-owned top eight CROs, which prompted us to weigh up the firms in the event that either goes public in the near future.
Making clinical trials more open has pros and cons for CROs and drugmakers according to experts from Amgen, Celgene, AstraZeneca, Icon and Lab Corp who spoke at an industry conference in Spain last week.
Lack of funding is threatening development of a nasal spray vaccine shown to provide long-term protection for non-human primates against the Ebola virus, the lead researcher told this publication in an exclusive interview.
Patient safety and efficacy endpoint data collector ERT has acquired eClinical Insights (eCI), a provider of cloud-based clinical trials management software, for an undisclosed sum.
The Chinese authorities are supplementing their current regulations around clinical trials with new mandates for the hospitals that conduct the studies.
The IPO boom for CROs is kicking off with INC Research’s stock offering, which as of Friday afternoon saw a nearly 10% rise, meaning the company raised more than $150m.
GSK is keeping its Ebola vaccine production in-house, despite previously leaked documents which suggested the company could not ramp up volume of BS-2 manufacturing without impacting its other vaccine lines.
Lab Corp will buy Covance for $6.1bn in a surprise deal that follows another quarter in which early phase gains were offset by underperformance in central labs.
Quintiles reported almost 14% growth in revenue, which was largely due to increasing revenue from its Integrated Health Services (IHS), which saw almost 35% quarterly growth.
The World Health Organisation says a meeting between drugmakers and high-level government representatives last week has yielded plans to fast-track scale-up of Ebola vaccines in the face of incomplete trials and leaked production problems.
Although the barriers for going paperless are relatively low for CROs, the service providers have yet to fully adopt electronic TMFs (trial master files), a new survey says.
India will ban PET packaging for liquid drug formulations for children, the elderly and women of reproductive age in November according to a Government statement.
Ebola vaccine developers can seek scientific guidance and approval through a rolling assessment system established by EMA to accelerate the process review.
The head of the US National Institutes of Health has said the organisation would have developed a finished Ebola vaccine by now if its funding had not been slashed over the last decade.
A seasonal flu vaccine taken in the form of an oral solid dose has been found comparable to currently available jabs, according to data presented by developer Vaxart.
EMA tells us it looks forward to continuing close relationship with DG SANCO
DG Health will keep responsibility for the EMA according to European Commission President-elect Jean-Claude Juncker, who confirmed plans to hand the agency to DG Enterprise have been abandoned.
