01-Apr-2010 - Hyde Engineering + Consulting has opened an office in Dublin, Ireland, enhancing its ability to provide Europe-based biopharm with compliance, qualification and automation services.
30-Mar-2010 - The WHO has published its views on the production of starting materials in draft guidance which details recommendations to ensure product quality while keeping costs down.
29-Mar-2010 - The European Medicines Agency (EMA) has recommended a recall of Acino’s generic Plavix (clopidogrel bisulfate) because of alleged failings in GMP at the API production facility.
25-Mar-2010 - The UK budget was “a missed opportunity” to encourage manufacturing, according to UK Chemical Industries Association (CIA), but was free from unexpected tax increases.
23-Mar-2010 - GSK has confirmed that material from the PCV1 virus has been detected in Rotarix and, although there is no evidence of a safety risk, the FDA has recommended use is temporarily suspended.
18-Mar-2010 - The Botswanan government is seeking to initiate local pharma manufacturing, which would lower drug prices, by entering into public-private partnerships (PPP), according to a report by F&S.
18-Mar-2010 - Millipore has expanded its microbial detection offering with Milliflex Quantum which, it says, enables manufacturers to respond to contamination issues earlier in the drug and vaccine production process.
16-Mar-2010 - GSK, Genentech, BIO and PDA have stated that it is “unnecessarily burdensome” for pandemic production plans to conform to parts of 21 CFR and requested that the FDA revises its draft guidance.
15-Mar-2010 - Merck & Co has joined a coalition to build a vaccine facility which is capable of simultaneously manufacturing multiple products and can quickly switch in response to a crisis.
10-Mar-2010 - Pharmadule AB is creating a complete modular biologics production facility, which will be 80 per cent completed in its workshop before delivery, to Lithuania-based Silcor Biotech by 2011.
09-Mar-2010 - Mettler-Toledo CI-Vision has developed a new 360 degree bottle inspection system to spot packaging and labelling defects.
03-Mar-2010 - The US FDA wants to boost the production of cell-based viral vaccines and says new guidance will help manufacturers.
02-Mar-2010 - Stratophase and GSK are part of a consortium developing a multi-parameter device capable of performing the real-time monitoring of key criteria needed to employ QbD in API production.
24-Feb-2010 - The FDA has issued Eli Lilly with a warning letter detailing a significant deviation from cGMP at its API production facility in Puerto Rico, which makes ingredients used in Humalog (insulin lispro), a diabetes treatment.
22-Feb-2010 - The Chinese API sector shrank last year after a number of high profile quality problems hit demand from Western markets, according to new analysis by outsourcing consultant JZ Med.
16-Feb-2010 - Counterfeit drugs worth €10.5bn ($14.3bn) are sold in Europe each year with Germans and Italians being the biggest consumers of such products, according to new Pfizer sponsored research.
09-Feb-2010 - MDRNA’s liposomal drug delivery formulation, DiLA2, lost no potency when stored for 12 months in conditions ranging from -80ºC to 4ºC, helping to validate it for administration of UsiRNA.
09-Feb-2010 - Almost half of antimalarials in Senegal are substandard, according to a USP study which will be used by local regulators to focus efforts on high-risk products, brands and geographies.
08-Feb-2010 - The EFCG has welcomed the addition of excipient GMP requirements to the draft amendments of the EU falsified medicines directive but warned that deeper analysis is needed to establish which products warrant further regulation.
26-Jan-2010 - Detection of Mycoplasma contamination in biologics manufacture can be cut from up to 35 days to four hours using Millipore’s MilliPROBE, according to the company.
25-Jan-2010 - Nanotechnology safety legislation designed to address potential health and safety risks posed by the technology has been introduced to the US Senate.
19-Jan-2010 - Johnson & Johnson (J&J) has expanded its US OTC drug recall after revealing that many more products than first thought may be contaminated by the wood dye, 2,4,6-tribromoanisole (TBA).
14-Jan-2010 - SyberWorks is collaborating with the Validation and Compliance Institute (VCI) to provide FDA compliance training, including a programme covering cGMP production.
13-Jan-2010 - Genzyme has reported a small dip in preliminary fourth quarter and full year revenues, driven by declining sales of Cerezyme and Fabrazyme which have been affected by manufacturing problems.
12-Jan-2010 - Continuing production of medically necessary products (MNPs) in the event of a pandemic will be made easier by developing a contingency plan, according to the FDA which has issued guidance on the subject.