02-Feb-2011 - The EU and US are using substandard medicines as an excuse to tighten IP rules, boosting pharma profits while making it harder for the poor to access drugs, according to Oxfam.
27-Jan-2011 - Mitsubishi Tanabe Pharma has recalled three lots of injected drugs made at its plant in Ashikaga, Japan after “some aspects of [quality] testing were inadequate.”
26-Jan-2011 - Failure to reduce counterfeiting is one of a number of issues slowing healthcare regulation harmonisation in ASEAN.
25-Jan-2011 - Hospira has confirmed it will no longer make Pentothal - an anaesthetic used in lethal injections – as the company “never condoned” its use in executions.
25-Jan-2011 - Baxter has shut down a production area at its plant in Castlebar, Ireland, telling the EMA it cannot guarantee peritoneal dialysis (PD) solutions made there are free of endotoxin contamination.
24-Jan-2011 - The US FDA has suggested pharmaceutical firms use a maximum bead size of 2.0mm for modified-release drugs formulated for “sprinkle” delivery to avoid problems resulting from inadvertent chewing.
24-Jan-2011 - Genzyme will build a second manufacturing plant in Geel, Belgium to ensure it has the capacity to meet demand for its Pompe disease drugs Myozyme and Lumizyme.
20-Jan-2011 - Teva has confirmed it will cut 200 jobs this year after a voluntary hold was placed on all manufacturing at its Irvine, California, US facility.
17-Jan-2011 - Bristol-Myers Squibb has recalled 64m tablets of its Avalide blood pressure drug in the US and Puerto Rico over fears it has the potential for reduced efficacy.
17-Jan-2011 - German technology group Schott and Japan’s Naigai Glass Industry Company have teamed up to enter the country’s pharmaceutical packaging market.
13-Jan-2011 - Telstar Group and Puretech Process Systems are teaming up to meet the flood of pharma and biotech demand for water treatment technologies.
13-Jan-2011 - KV Pharmaceutical saw its share price plummet after an FDA delay prompted it to evaluate its liquidity outlook.
13-Jan-2011 - Genzyme has lowered 2011 financial projections after delaying the date it expects Fabrazyme production to return to normal.
12-Jan-2011 - Mobile software developer Wind River says Fedegari Autoclavi has adopted its VxWorks real-time operating system (RTOS) for its Therma4 control systems for its industrial sterilisation machines.
10-Jan-2011 - Sixty-two workers at Wanbei Pharmaceutical’s manufacturing facility in Suzhou, China have been sickened after a chemical leak.
10-Jan-2011 - Legislation and resources are needed to support Croatian pharmaceutical regulators in preparation for accession to the European Union (EU).
06-Jan-2011 - in-PharmaTechnologist.com presents a round up of cGMP related warning letters published recently by the FDA.
06-Jan-2011 - Instrument supplier Mocon has taken its business to new heights, literally, by installing two testing units at a Government pharmaceutical laboratory in Lhasa, Tibet.
05-Jan-2011 - The European Medicines Agency (EMA) has highlighted the quality APIs manufactured outside the EU as an area of concern in the draft 2015 road map it unveiled this week.
04-Jan-2011 - GSK says there is no evidence that patients were harmed as a result of production issues at its manufacturing plant in Cidra, Puerto Rico.
03-Jan-2011 - The US FDA has finally become a member of the Pharmaceutical Inspection Convention and Pharmaceutical Co-Operation Inspection Scheme (PIC/S) after a five-year application process.
03-Jan-2011 - US drugmakers Luitpold and Cumberland have both withdrawn injectable pharmaceutical products after contamination concerns.
23-Dec-2010 - Regulations and enforcement were big topics yet again in 2010. in-PharmaTechnologist presents five of our most read on the topics, covering starting material quality and overseas inspections.
22-Dec-2010 - Catalent has been fined after contact with olanzapine led to employees developing dermatitis, an incident the company “deeply regrets”.
22-Dec-2010 - Johnson & Johnson (J&J) dominated recall and quality control (QC) news over the past year but others also faced issues. in-PharmaTechnologist presents five of our most read QC articles of 2010.