06-Jul-2015 - Toronto-based Attix Pharmaceuticals has received a US FDA warning letter after an inspection from November and a lack of corrective actions in the company’s response to the FDA.
News in brief
- Suspect Viagra pills seized in EU-wide swoop on organised crime gang
- Dutch pharma policy NGO Health Action International opens Brussels office
- EMA PSUR database fit for purpose
- Sobi terminates talks with unnamed suitor
- Indian industry group calls for clearer expiry date labelling rules for topic drugs
News in brief
02-Jul-2015 - More evidence linking fake pharmaceuticals and organised crime emerged today with Dutch police seizing suspicious Viagra pills along with cocaine, MDMA and burglary tools.
02-Jul-2015 - The UK health minister has announced plans to label all British prescription medicines with their cost to the taxpayer.
02-Jul-2015 - MHRA, the UK pharma regulator, says its staff cuts over the next three years will not impact its work with pharma.
01-Jul-2015 - Europeans who want to fund organised crime can now do so more easily by buying meds from web pharmacies that lack a new logo launched by the EC to stop the sale of fakes online.
01-Jul-2015 - The US FDA says has granted a four month amnesty to pharmacies which do not comply with new track-and-trace regulations that come into force today.
30-Jun-2015 - US IP rules and a string of recent court cases are reducing the types of inventions pharma companies can patent, and “calling into question entire portfolios,” says a specialist lawyer.
30-Jun-2015 - In response to a flood of requests over uncertainties regarding ICH Q7 guidance, the international consortium recently released a question and answer (Q&A) document intended help companies implement appropriate GMPs (good manufacturing practices) at all stages of the API supply chain.