07-Jan-2010 - The Hong Kong pharma sector should aim to adopt current World Health Organisation (WHO) GMP standards for drug manufacture within two years, according to a new report.
04-Jan-2010 - McNeil Consumer Healthcare has recalled all lots of its Tylenol Arthritis Pain caplet 100 count bottles in the US due to reports of nausea and stomach pain.
16-Dec-2009 - Sanofi Pasteur has recalled four lots of its pediatric H1N1 vaccine in the US that were found to have fallen below potency limits despite being be in spec at the time of manufacture.
09-Dec-2009 - The EU industry commissioner has said the scale of pharmaceutical counterfeiting “exceeded our worst fears” and the EPHA has weighed into the debate on the development of the draft directive.
07-Dec-2009 - Alexion Pharmaceuticals’ manufacturing facility in Rhode Island, US has received a positive opinion from the CHMP, furthering its efforts to gain in-house capacity to supplement a deal with Lonza.
03-Dec-2009 - Pfizer and Protalix have increased the pressure on Genzyme by signing a new accord to commercialise Uplyso (taliglucerase alfa), a potential rival to its Gaucher’s disease treatment Cerezyme, just days after the US biotech resumed production.
02-Dec-2009 - A MEP has questioned the EC’s estimate that 20,000 API producers supply the EU, which was used to justify not having mandatory inspections, and the CEO of Hovione added that the numbers have been “dramatically misunderstood”.
30-Nov-2009 - Sanofi-Aventis plans to participate with a Russian state-owned corporation in a project to attract innovative drug manufacturers to the country, using its insulin facility as a pilot initiative.
23-Nov-2009 - A five-day international anti-counterfeiting operation involving regulators, police and customs officials from 24 countries has resulted in the seizure of 167,000 counterfeit pills.
19-Nov-2009 - It is “legislative madness” to allow reimportation in the US, according to the chair of EAASM who spoke at AAPS about Europe’s “porous supply chain” and how it could affect the standard of medicines in the States.
17-Nov-2009 - Regulatory enforcement efforts to tackle counterfeit and substandard APIs are in disarray, according to Guy Villax, CEO of Hovione, who spoke at AAPS about the scale of the problem.
16-Nov-2009 - US FDA maintains market approval for key Genzyme drugs despite reports of steel and rubber fragments in some batches.
09-Nov-2009 - The ICH says it made progress on its S9 guideline on non-clinical data requirement for late-stage cancer treatments at its most recent steering committee meeting in Missouri, US.
05-Nov-2009 - US contract services firm Catalent has launched a new test service capable of detecting trace amounts of the toxic chemical melamine in pharmaceuticals.
05-Nov-2009 - Particulate Systems (PS) and Surface Measurement Systems (SMS) have entered into a strategic collaboration drawing on their knowledge of using analytic equipment for the characterisation of particulate, porous and complex materials.
28-Oct-2009 - Nokia, SAP and G&D are forming a company to provide anti-counterfeiting services which will draw on the firms’ respective expertise in mobile phones, supply chain technology and encryption.
28-Oct-2009 - CDC Software has launched Trace Express Viewer which helps identify suspect materials, provides cGxP compliant transaction processing and covers users’ ePedigree requirements.
27-Oct-2009 - Malvern Instruments and Kaiser Optical Systems have teamed up to meld Raman spectroscopy with particle characterisation in a unique combination that has application across the drug development and manufacturing process.
26-Oct-2009 - Portuguese CMO Hovione has bought an aseptic spray-drying line from US firm Acusphere and says that the demand for the technology is increasing as drug firms aim to boost bioavailability.
21-Oct-2009 - The FDA has warned consumers about the spread of counterfeit H1N1 treatments after the agency bought products advertised as Tamiflu (oseltamivir) that contained none of the active ingredient.
21-Oct-2009 - US drugmaker Bristol-Myers Squibb will close its QC facility in Evansville, Indiana by the end of the year according to reports in the local media.
21-Oct-2009 - Kimberly-Clark Professional has launched Kimtech Pure A5 cleanroom coveralls, for sterile and non-sterile environments, to provide an affordable way to reduce the risk of contamination.
19-Oct-2009 - The EC’s plan to make excipients comply with GMP is “still alive”, according to Cargill which spoke to in-PharmaTechnologist at CPhI about its Zerose erythritol product that it claims can improve compliance.
15-Oct-2009 - As CPhI 2009 draws to a close we take a look back on the show, which, despite some negatives, appears to have been an overall success.
12-Oct-2009 - The USAID and USP have launched a campaign to tackle counterfeits in Cambodia and Greater Mekong Subregion, using a film to educate the population of the dangers of fakes and need to use legitimate pharmacies.