Pharma companies may be moving away from global CROs and towards more specialised early phase partners, according to German firm CRS who has inked a partnership deal with Bayer.
In an effort to stave off expected drug shortages, the EC has approved a waiver that will allow US API manufacturers to export their products to Europe.
SCM Pharma says its new contract manufacturing facility will cater for clients upscaling towards commercial production and the trend towards orphan drugs.
Drugmakers have been slow to adopt releasable PEGylation according to Belrose Pharma, which plans to use a tech it has bought from Enzon to expand the market.
Ash Stevens is planning to expand its API manufacturing facility in Michigan, which was recently approved by the US FDA to produce Ariad Pharmaceuticals’ oncology drug Iclusig (ponatinib).
As private equity firms look to cash in on their investments, CROs could consolidate more, especially as the market for middle- and top-tier CROs gets more competitive, experts say.
The Big Pharma company has licensed a range of compounds to molecule research tools company Abcam to be made available for sale to pre-clinical researchers.
Europe could face drug shortages if the US is not granted exemption from new API import requirements, according to a US chemical industry trade association.
The DEA has approved AMRI’s Burlington facility to work with Schedule 2 controlled substances, placing it in a competitive position to win contract manufacturing bids, the company says.
Pfizer has chosen three of Synexus' clinical research centres in South Africa to be a part of its 100-site INSPIRE programme based on the sites’ experience and audit history.
Ambrx and Zhejiang Medicine have selected Wuxi to accelerate the development of a potential ADC (antibody drug conjugate) targeting Her2-positive breast cancer.
Shasun Pharmaceuticals’ says it is trying to restart operations at the earliest opportunity after workers went on strike at its API and formulation facility in India last Sunday.
The latest technology platform from Capsugel's four-month old DFS Unit offers greater bioavailabilty and stability in oral dose formulation, says the company.
Manufacturers’ quality issues were among the most prevalent reasons for drug shortages, according to a survey conducted by the ISPE (International Society for Pharmaceutical Engineering).
The US Supreme Court has ruled unanimously that naturally occurring DNA is not patentable “merely because it has been isolated,” but synthetic DNA can be patented.
Catalent says customers are applying controlled release technology to transform drugs into better treatments across all stages of development as it expands its Kentucky manufacturing site.
Pharma employees who report manufacturing misconduct to stop adulterated drugs getting to market put their careers at risk and face being blackballed by industry says an American advocacy group.
Biosimilar developers such as Mylan and Pfizer are taking issue with FDA draft guidance that in some circumstances could extend biosimilar development timelines and discourage their development.
Canadian CMO Patheon’s second quarter revenues increased almost 40 percent as the company’s commercial manufacturing services revenues saw a similarly high rise over the same period from last year.
Some Chinese firms wont have the 'written confirmations' required to ship APIs to the EU from July according to the German audit firm tasked with helping manufacturers prepare by Beijing industry group, CCCMHPIE.
GSK has ‘paused’ a Phase I trial of an MS drug and fired its China R&D chief, Jingwu Zhang, after finding 'manipulated' data in a paper published in Nature Medicine in 2010.
Failure to clean up unsanitary conditions at a US plant and address cGMP violations at a facility in Puerto Rico have earned Baxter another warning from the US FDA.
In a rare win for a CRO, Quintiles was awarded a two-year, $1.088M research grant from the Patient-Centered Outcomes Research Institute (PCORI) to compare the effectiveness of uterine fibroid treatments.
Altasciences’ purchase of Vince and Associates Clinical Research highlights the industry's shift to conducting more specialized Phase I trials in patients rather than healthy volunteers, experts say.
Packaging specialist Contract Pharmaceutical Services of Australia (CPSA) has received a warning letter from the US FDA due to humidity control violations on products distributed in the US.
Epidemiological and other medical research could be prohibitively difficult to conduct if a new European regulation is passed, according to three professors from the University of Amsterdam.
