Roundtable discusses creating a biogeneric pathway
The challenges in establishing a regulatory pathway for biogenerics were discussed at a recent FTC roundtable, with a FDA official saying in most cases it will be “impossible” to establish that the APIs are identical.
Enzon biotech sale under threat
The possible sell-off of Enzon Pharmaceuticals’ biotechnology drugs business has come under fire by one of the firm’s shareholders, DellaCamera Capital Management, which says it is opposed to the move.
Lawsuit filed claiming Pfizer PCB release
A Terre Haute, US resident has filed a lawsuit against Pfizer alleging that the company “negligently or recklessly” maintained its dam, resulting in the release of PCB.
Taiwan’s biotech statute continues to attract global players
Taiwan’s efforts to position itself as a major biotechnology hub received a further boost today with the opening of Merck KGaA’s dedicated technology training centre in Xizhi City, Taipei County.
SSB signs deal for virus clearance tech
Sartorius Stedim Biotech (SSB) and Bayer Technology Services (BTS) have signed an exclusive cooperation agreement for the manufacture and marketing of UVivatec products.
EU votes in chemical labelling law
The European Parliament has voted in favour of incorporating the United Nations’ (UN) Globally Harmonised System (GHS) for chemical packaging into EU law.
Piramal expands contract services and research
India-based Piramal Healthcare has extended the range of early phase drug product development and manufacturing on offer at its Morpeth, UK facility.
Pharma manufacturing: People on the move
in-PharmaTechnologist.com presents its latest round-up of personnel changes in the pharmaceutical manufacturing sector.
Pharma manufacturing products: News in brief
in-PharmaTechnologist.com’s latest round up of products launched in the pharmaceutical manufacturing sector includes new offerings from Premier Pneumatics, GE Healthcare and WaterSep.
Agilent and Millipore join forces to further epigenetics research
Agilent and Millipore have formed a collaboration to develop fully validated chromatin immunoprecipitation (ChIP) microarray kits that will improve productivity and streamline epigenetic analysis.
Abraxis and ProMetic target US biopharma market
Abraxis has licensed rights to use ProMetic’s protein technology in the development of four new biopharmaceuticals that it hopes will generate around $600m (€422.5m) in US sales.
Contract manufacturing: News in brief
in-PharmaTechnologist.com’s latest round up of developments in contract manufacturing includes Therapure’s launch and facility expansions by Hollister-Stier, West and Dow.
UCB refocuses and cuts workforce 17%
UCB is moving forward with efforts to focus on CNS disorders and immunology and plans to cut around 2,000 jobs as part of its SHAPE restructuring program.
Applied Biosystems removes the bias from gene expression analysis
Applied Biosystems (ABI) has developed a sequencing-based tool for gene expression analysis that can detect even minute amounts of previously unknown RNA transcripts.
Vaccine sales help Crucell cut Q2 loss
An increase in the sale of vaccines such as Quinvaxem and Epaxal, helped Dutch drugmaker Crucell reduce its loss some 56 per cent to €7.9m ($12.5m) in the second quarter.