Canadian contract manufacturing and testing firm Garmen Laboratories will be acquired by Cancer drug developer Advanomics Corp in a deal announced today.
Dyax says the entry of its human antibody drug candidate DX-2930 into clinical trials is thanks to successful development and up-scale manufacturing by Laureate Biopharma.
Higher demand for methadone, buprenorphine and opiates coupled with the positive impact of a recent acquisition drove first half growth at Swiss supplier Siegfried.
Duke University will play contract research organisation (CRO) for clinical trials of a Parkinson’s disease treatment being developed by International Stem Cell Corp (ISCO).
Swiss API manufacturer Siegfried reported that higher API sales and custom synthesis orders drove a profit increase in the first half of the year and predicted that recent capacity hike and new China plant would help maintain positive momentum.
Amgen has spent $10.4bn (€7.8bn) in acquiring Onyx Pharmaceuticals saying its oncology products and pipeline will be strengthened by Amgen’s manufacturing capabilities.
Description of the manufacturing process in regulatory submissions must be the same whether the applicants use Quality by Design (QbD) or the traditional approach, the FDA and EMA have concluded.
Cutbacks are prompting more sponsors to outsource library design and screening during drug discovery according to UK-based software and consulting firm Cresset.
Covance has upgraded blood tube processing and kit production capabilities at its US central labs unit and says the efficiency drive is helping sponsors make better decisions.
Jubilant HollisterStier (JHS) says expansion of its sterile manufacturing capacity at its facility in Kirkland, Canada will be used to fulfill several new contracts.
Private equity group Parthenon Capital Partners has acquired eClinical services firm Bracket from US pharmacy benefit management organization Express Scripts.
Pfizer has remained the world’s largest public manufacturer of pharmaceuticals, according to an industry report, though dropped revenue in 2012 has left Novartis hot on its heels.
The MHRA says it will assess the quality of active pharmaceutical ingredients (APIs) imported from outside the EU at manufacturers’ facilities rather than at UK borders.
NanoViricides' nanotech drug delivery platform has the potential to eliminate viruses, the firm says as construction began on a manufacturing facility to support upcoming clinical trials.
German CMO Rentschler landed APN311 production deal thanks to location and cell culture based manufacturing skills according to BioPharma Apeiron Biologics.
A Non-profit group focused on reshaping the clinical research will have started registering research sites as part of an effort to set up a global network.
CROs have an important role to play in reducing the number of animals used in drug development and – potentially – much to gain by doing so, according to the European Commission.
Over the next three years Pfizer will work with the Sanford Burnham Medical Research Institute to discover therapeutic targets to prevent and treat complications related to obesity and diabetes.
The two-year pilot project will help the US Food and Drug Administration further assess the growing number of companies and countries involved in importing drugs to the US.
Codexis has denied breaching its licensing deal with Dyadic International and says losing rights to the C1 fungal expression system would hit its CodeXyme business hard.
CRO momentum in Asia is picking up as Icon has partnered with a clinical research centre at the National Taiwan University Hospital to accelerate drug development on the Chinese island.
The TransCelerate BioPharma industry group has launched its clinical trial comparator network to establish a reliable means for sourcing quality drugs for clinical trials.
Quintiles today announced it will expand its reach into the world of oncology, medical device and diagnostic trials with the acquisition of CRO Novella Clinical.
Early phase CRO Velesco Pharma has opened a new business development office in the greater Boston area to be closer to its existing and prospective clients.
Agilent Technologies and SomaLogic will partner to expand the dissemination of Soma’s proteomic assay to at least five academic and contract research centers by the end of the year as demand for the tool has skyrocketed among biopharma companies.
Having been granted a series of patents, MedSpray’s ‘patch-in-a-can’ spray-on-film technology can offer dermatological, topical and transdermal drug delivery, says MedPharm.
Consolidating its Indian injectable business under a new subsidiary will improve focus and align quality control, says Aurobindo who has invested in two manufacturing companies to support such plans.
As the modernization of the informed consent process looks to keep patients better informed with electronic presentations of trial information, sponsors and CRO may also utilize the tech to track more data.
Albany Molecular Research's (AMRI) stock fell more than 10% on Monday after announcing in an SEC filing that it was informed by its partner Bristol-Myers Squibb that it would terminate the development of an investigational depression drug.
The licensing and potential purchase of the Taper Dry Powder Inhaler (DPI) technology from 3M complements Adamis’ portfolio and future formulation expansion, Adamis says.
The US FDA has finalized guidance on clinical trial oversight, calling for more remote and targeted risk-based monitoring, though some experts believe such monitoring should be more judiciously employed.
CRO Parexel’s revenue, net income and earnings per share grew substantially in Q4 when compared to the same quarter last year and the company expects similar growth in the next fiscal year.
