Clinical trials of cancer vaccines should enrol patients with no evidence of residual disease, according to FDA guidance, but this will increase development times compared to cytotoxic agents.
ATMI has launched a powder transfer bag, for substances such as APIs and excipients, which it claims has three times the shelf life of alternatives, increases process efficiency and improves safety.
Northern Irish Packaging specialist Sepha says increasing pressure to reduce waste is driving drug industry demand for its range of Press-Out deblistering technologies.
The FDA is to establish current good manufacturing practice (cGMP) requirements for combination products to eliminate inconsistencies that could affect product safety and public health.
Japanese CRO CMIC says rising demand for Medidata Solutions’ Rave EDC system in Asia drove its decision to seek top-level provider status under the US firm’s accreditation scheme.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at Catalent, MedSource and IGI Laboratories and PHT.
Increased use of adaptive clinical trials and biomarkers will benefit smaller laboratory services companies, according to Pacific Biometrics (PBI) that turned its operating income from loss to profit in fiscal 2009.
Dutch contract delivery services firm OctoPlus says it will cut 35 jobs as part of ongoing efforts to boost efficiency, improve competitiveness and broaden its client base and revenue streams.
Fierce competition from India and China means it is unlikely that CROs and CMOs in CEE can generate sustainable growth, according to a report that believes the service model must be a “stepping stone” to creating innovative R&D businesses.
Canadian biologics CMO BioVectra has been contracted to make trial supplies of the candidate cancer treatment Prolanta by US biopharmaceutical firm Oncolix.
Having filed for bankruptcy in December Introgen Therapeutics has sold its assets, including management and technical team, to Vivante, a company that formed last week as a contract manufacturing organisation (CMO).
The Pan-African Clinical Trials Registry (PACTR) has become the first such database to be endorsed by the WHO, providing the world with access to studies on the continent and improving efficiencies.
US CRO Health Decision says the new “Monitor View” module for its HD360 trial management system makes assessing study site performance an easier and more cost effective process.
West has opened its first manufacturing facility in China to meet rising demand but the process has taken since 2006 and been “very tedious”, its president of West Asia Pacific told Outsourcing-Pharma.
in-PharmaTechnologist presents its latest round up of appointments in the pharma sector, including a new president of Eli Lilly USA and a resignation over disagreements at Caraco.
UK based contract API maker Aesica Pharmaceuticals has been granted a Home Office license to make controlled substances at its facility in Cramlington, Northumberland.
The Chao Center for Industrial Pharmacy and contract manufacturing is to donate $360,000 worth of the antibiotic Seromycin to the Global Health Committee’s fight against multidrug rtesistant tuberculosis (MDR-TB) in Cambodia and Ethiopia.
A US court has ordered the USDA to disclose 1,017 pages of animal testing documents relating to its investigation into HLS, despite testimonies stating that their release could be detrimental to the CRO’s business.
ethica Clinical has added biomarker data analysis technology to its roster of services in a C$1.25m (€782,899) deal with fellow Canadian CRO Matrix Pharma.
Quintiles has opened its expanded facility near Edinburgh, Scotland, which has doubled its central lab capacity with the intention of improving the CRO’s service offering in Europe.
Ampac Fine Chemicals (AFC) has added three new commercial-scale Hastelloy liquid-liquid centrifuges to its API making business in a move that, it says, will increase batch size and lower manufacturing costs.
GATC Biotech has expanded its human genome sequencing services and, having performed a pilot study, is “amazed” by the potential the techniques have for cancer research and diagnostics.
US approval for Sanofi-Aventis’ H1N1 vaccine last week is an “example of extremely rapid action by [the] FDA” that should be used more widely, according to Parexel Consulting’s VP of global strategy services Alberto Grignolo.
Improved access to data and the ability for users to share comments are among the features added to latest version of Veracity, an electronic data capture (EDC) system from Kika Clinical Solutions.
Philips has entered into a joint research programme to evaluate ThermoDox with MR-HIFU, a combination therapy that could provide a precise, non-invasive way to treat difficult cancers.
Portugese CMO Hovione has had its captisol manufacturing contract extended until 2019 in a new agreement with US specialty drugmaker CyDex Pharmaceuticals.
LGC Standards has made the “next logical step” in its “concerted effort” to expand internationally by opening an office in St Petersburg, Russia, less than six months after it moved into China.
US CMO Florida Biologix (FB) says its new contract with America Stem Cell (ASC) shows that demand for trial-phase biologics manufacturing is starting to recover.
Bio-Path Holdings has signed an exclusive licence to develop a liposomal tumour targeting technology that delivers antisense and FAK siRNA and cuts toxicity.
The GAO sting operation and subsequent increased scrutiny will “definitely change how pharma and CROs choose IRBs”, according to the VP of NEIRB who spoke to Outsourcing-Pharma after successfully completing a FDA audit.
Israeli generics giant Teva Pharmaceutical Industries will close one of its manufacturing plants in the Czech Republic by the end of the year, resulting in the loss of around 400 jobs.
The FDA is hoping to increase the likelihood of a clinical trial being successful by making best use of science and alternative study designs and has issued end-of-Phase IIa (EOP2A) meeting guidance to explain the process.
Dalton Pharma Services has rolled out a new formulation development service that completes the firm’s contract drug manufacturing offering according to CEO Peter Pekos.
Gerresheimer is increasing its presence in the pharmaceutical plastics business, which it believes is increasingly important, by opening an R&D centre in the US and a production facility in Spain.
San Diego’s TriLink BioTechnologies has restarted its contract oligonuclotide radio-labelling service after receiving “anxious phone calls” from pharma customers, according to CEO Richard Hogrefe.
Coupling interferon to a synthetic PEG molecule could increase the therapeutic’s dosing schedule from every other day to every one to two weeks, according to researchers who believe the technology has blockbuster potential.
The Sentinel Initiative will help pharma and CROs pinpoint study objectives, according to a director at PRA who told Outsourcing-Pharma about the company’s postmarketing safety surveillance.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing space, including appointments at IMS Health, CPTC and LAB Research Canada.
UK CMO SCM Pharma says its new commercial supply service, due to be officially launched at next month’s ICSE conference in Madrid, has already won two long-term manufacturing contracts.
Shanghai The First Biochemical & Pharmaceutical Company has installed Praxair China’s NCOOL cryogenic heat exchanger, becoming the first company to sign this sort of liquid nitrogen supply contract.
The North American launch of a new range of mLLDPE resins will result in greater lightweighting, cost savings and sustainability for flexible packaging in the region, said manufacturers LyondellBasell.
Funding increases have failed to boost pharma drug development productivity and, with budgets tightening, the industry must revise its operations to improve output, according to a research paper.
in-PharmaTechnologist presents its latest round up of movements in the pharma space, including appointments at Sanofi-Aventis, MorphoSys and Ironwood Pharmaceuticals.