Capsugel says it is bolstering its service to offer specialised dry powder inhalation (DPI) formulations, allowing biotherapeutics to be delivered to the lung rather than by injection.
A new study is shaking up ideas about a known therapeutic strategy for Alzheimer’s disease, following a discovery by scientists at Scripps Research Institute testing enzyme inhibitors.
Cloud-based tool provider Medidata has built an open-source connector linking the new Apple ResearchKit with its cloud to enable biopharma companies, CROs and academic institutions to map data generated by ResearchKit apps.
Wasting no time in furthering its lab-based JV with Quest Diagnostics the world’s largest CRO Quintiles has opened a GLP-compliant bioanalytical liquid chromatography-mass spectrometry (LC-MS) laboratory in Oss, the Netherlands.
Inaccurate and incomplete information on excipients referenced in the US FDA Inactive Ingredient Database (IID), as well as other agency policies and guidance on the review of inactive ingredients in ANDAs (Abbreviated New Drug Applications) “continue...
Persuading API manufacturers to seek prequalification is a challenge according to the WHO, which wants to raise awarness about the process and the positive impact it has on a suppliers' reputation.
Despite a growing interest in adaptive clinical trial (ACT) designs, few designs have been used relative to the overall number of trials conducted, and more ethical concerns need to be considered, according to a new study published Sunday from University...
A liquid-gel which solidifies in the stomach could offer drugmakers an effective modified-release delivery option, according to the lead scientist behind the project.
WuXi PharmaTech subsidiary WuXi Biologics has begun construction on a new $150m biologics manufacturing facility in Wuxi, China, which is expected to be the largest mammalian cell culture manufacturing sire using disposable bioreactors in the world.
A number of small, mid-sized and large CROs (contract research organizations) and other companies tied to the world of clinical research have announced various partnerships and other financial moves over the past week. Here’s a roundup of the latest:
Indian generics firms see opportunities in the Japanese drug market according to a trade delegation that visited Tokyo last week seeking supply contracts.
Though making the switch from batch to continuous manufacturing may be difficult, costly and time consuming, pharma manufacturers and CMOs should begin to consider the switch as in the long-run it will end up saving companies time, money and space, FDA’s...
Although Parexel’s consolidated service revenue increased by only 2% for the quarter, the company reported that its backlog included gross new business wins of $942.4m, which was 5.3% higher than the same quarter as last year.
With the aim of getting new drugs to patients more quickly, a new House draft bill released Wednesday offers a whole set of new ideas around what the NIH and FDA can do to speed drug discovery and development.
Charles River Laboratories saw only slight growth in revenue compared to the same quarter last year, which was driven by its safety assessment and endotoxin and microbial detection businesses, and double-digit revenue increases from mid-tier biotech clients.
China-based contract research and manufacturing company WuXi PharmaTech has received a proposal to be taken private by a consortium led by its CEO and Ally Bridge Group Capital Partners.
As the cost of clinical trials continues to grow, Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA told Senators earlier this week that there are “ways to greatly improve clinical trial efficiency,” and cut costs through...
CRO Quintiles’ recent purchases of oncology and medical device specialist Novella and EHR service firm Encore Health Resources are starting to reap new benefits for the world’s largest CRO, the company reported in its earnings call on Wednesday.
Japanese drug firms eyeing international investments should not be put off by Daiichi Sankyo’s turbulent ownership of Ranbaxy according to an Indian delegation in Tokyo last week to seek collaborations.
Lonza has predicted that revenues and profits will grow in 2015 despite the strong franc, citing pharma portfolio optimization and demand for outsourced manufacturing services.
Biotech giant Amgen has begun hiring about 100 more research scientists and production engineers as part of an expansion at its office in Cambridge, Massachusetts at the same time as laying off more than 2,000 employees at other sites.
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)
Nearly a week since Pfizer formally announced its third CRO partner as PPD, the spotlight shifted to Icon as the CRO earns nearly one-third of its revenue from Pfizer.
With sky-high valuations and soaring M&A prices, the question of whether there’s a biotech bubble continues to crop up, though now some analysts are saying this so-called bubble and its inevitable pop may be a cause for concern for CROs (contract...
Hospira has recalled one lot of the anaesthetic Bupivacaine after a customer discovered orange and black particles floating and embedded in a glass vial.
CRO INC Research saw its net service revenue increase by 14.5% to $211.5m in Q1, which was considerably higher than analyst expectations and driven by particularly strong growth in trials around CNS (central nervous system), oncology and other complex...
Just two months after Covance shareholders signed off on LabCorp acquiring the company, and all seems to be going according to plan, though financial expectations for the rest of the year were slightly lowered by the diagnostics company.
AstraZeneca has inked a development and commercialisation deal with Celgene for its haematology programmed cell death ligand 1 (PD-L1) candidate, MEDI4736.
‘Epoch making’ revisions to Japanese drug laws have provided a pathway for development of safer, more innovative drugs according to MHLW director, Haruo Akagawa.
Reluctant doctors and varying reimbursement policies are affecting biosimilar trial recruitment, experts said at the European Generics Association’s biosimilars conference in London last week.
Medidata has reported its strongest ever quarter and says strategic CRO partnerships and risk-based monitoring offer opportunities to penetrate more of the market.
As 20 of the largest biopharma companies have now joined industry group TransCelerate, the group is beginning to use patient centricity and connectivity to influence the clinical trial environment, CEO Dalvir Gill told attendees at the Partnerships in...
Cheaper disposable manufacturing techs and increased demand for outsourced production will see more CMOs enter the contracting sector according to HighTech Business Decisions
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.
Agilent Technologies has launched a quadrupole-time of flight (Q-TOF) mass spectrometry system for applications including food safety and pharmaceuticals.
Pfizer reduced costs 40% without cutting jobs at a facility in Sweden using an alternative approach to organisational and cultural behaviour, and hopes to do the same at its newly acquired Austrian plant.
Merck & Co. has struck a deal with Organovo to use a 3D printed human liver system for toxicology testing as a supplement to in vitro and preclinical animal testing.
