The European Directorate for the Quality of Medicines & HealthCare (EQDM) has begun Phase 2 of its “track & track” anti-counterfeiting strategy and is seeking manufacturer participation.
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.
The EU and India have resolved a dispute about the seizure of generic medicines passing through Europe on route to Africa and Latin America, according to reports.
Clinical trials in Latin America recruited 91 per cent more patients per site than studies conducted in the US from 2005 to 2009, according to EU MAA data.
Minipigs are a practical and flexible model for safety testing which probably provide better prediction of toxicity in humans than rats and dogs, according to EU funded research.
Univar is now exclusively distributing Dow's Carbowax Sentry PEGs in Europe and the range is proving popular at CPhI 2010 with manufacturers facing restricted supply from other sources.
Pharming has entered into a toll manufacturing agreement with Sanofi Chemie to boost capacity, secure supply and lower costs of Ruconest (conestat alfa).
Hungary-based Ubichem Research has gained approval to supply cGMP radiolabelled APIs in the European Union (EU), positioning it to benefit from increased demand.
Kuehne + Nagel is providing Boehringer Ingelheim with temperature-controlled road transportation of medical products to Czech Republic, Poland, Hungary, Greece and Croatia.
The IPEA's issuance of good manufacturing practice (GMP) “certification” is mark of manufacturing quality, says US specialty chemicals supplier W R Grace & Co.
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.
Lek has opened a 430m² modified protein manufacturing facility in Slovenia to produce epoetin alfa drug substance for use in the biosimilars marketed by its parent company, Sandoz.
Clinical trials are often biased against the recruitment of older people says the European Union's PREDICT group, which has launched a charter designed to protect such patients' right to take part.
Companies are failing to protect their products with tamper evidence but the EU falsified medicine directive, plus the ease of implementation, will drive adoption, according to a director at Schreiner ProSecure.
Environmental certification of production facilities should be introduced to GMP legislation and sustainability risk assessments linked to marketing authorisations, according to a MPA report.
The US Department of Justice (DOJ) has given partial approval for Amcor’s takeover of Alcan after announcing it would now limit its review to Alcan’s Medical Flexible operations.
Amcor’s takeover of Alcan has been cleared by the European Commission after the Australian company agreed to sell off two pharmaceutical and food packaging plants in Spain.
Amcor has unveiled its proposed management shake up in preparation for the $2.025bn takeover of Alcan – three days before the European Commission is due to deliver its verdict on the deal.
Officials carried out another set of surprise inspections at pharma companies yesterday, in the latest stage of the European Commission's clampdown on anti-competitive practices.
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.
Repeated mandatory inspection of overseas API facilities should be performed to prevent falsified products entering the EU, according to a committee which has published proposed amendments to the draft directive.
CDMO Haupt Pharma has invested in a combined heat and power unit (CPHU) for its site in Wolfratshausen, Germany, which is now expected to produce 14 per cent less CO2 a year.
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”.
IQWiG says Pfizer’s refusal to make some data available “hindered” its report on antidepressants and called for EU mandated trial registration and publication rules.
Amcor has indicated it would be prepared to sell a flexible packaging business to address European Union anti-trust fears over its proposed takeover of Alcan.
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.
Insulated packaging specialist ThermoSafe Brands has formed a supply partnership with German firm Storopack Hans Reichenecker in an effort to expand in Europe.
GlaxoSmithKline (GSK) and other pharmas concerned by parallel trade have been given encouragement by Europe’s highest court which said the EC must reconsider the company’s Spanish sale conditions.
Fierce competition from India and China means it is unlikely that CROs and CMOs in CEE can generate sustainable growth, according to a report that believes the service model must be a “stepping stone” to creating innovative R&D businesses.
Millipore has expanded its European biotech services business by acquiring BioAnaLab, a UK-based company that provides analysis of biologics and vaccines.
Rumours suggest that US drug giant Pfizer is considering a bid for Turkish generics group Abdi Ibrahim as part of its strategy of expanding in emerging markets.
Mylan has followed Teva’s lead by partnering to develop follow-on biologics (FOB), with the Indian generic maker regarding Biocon as the “ideal partner” to help it enter the market.
The Association of Southeast Asia Nations’ (ASEAN) member states will recognise each others GMP certificates as part of a programme intended to raise standards and eliminate trade barriers.
A US trade organisation has drawn up its own set of standards for Braille on pharmaceutical packaging in the absence of any legislative decision by the US.
Shipments of drugs that do not violate patent rights in the exporting or importing countries should not be seized in transit or labeled as counterfeit, as occurred recently, according to health advocates.
IMA chief financial officer Sergio Marzo says that although demand for its machines has been strong so far this year, the number of orders it receives in the second quarter will provide a better reflection of the pharmaceutical industry’s position.
Seidenader Vision is gearing up to launch a modular track and trace (T&T) solution which, it says, will give drug manufacturers the flexibility to adapt to the changing legislative landscape.
Haupt Pharma has acquired Pfizer’s production facility in Latina, Italy, which moves the contract manufacturer into antibiotics and allows it to provide additional services to clients.
Two months after the European Union (EU) released antitrust findings the FTC is suing Solvay Pharmaceuticals and two other companies for illegally agreeing to a delay generic’s release.
A new report suggests the large numbers of fake drugs produced in China could drive CMO customers away and see Central and Eastern Europe (CEE) emerge as a contract manufacturing hotbed.
