01-Jul-2015 - Europeans who want to fund organised crime can now do so more easily by buying medicines 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 intellectual property (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.
25-Jun-2015 - Charity Sense About Science is attempting to intervene in a UK CRO’s legal action against trial transparency.
25-Jun-2015 - Demand for CNS assets will help break records for pharma M&As in 2015, Neel Patel, VP of inVentiv Health consultancy Campbell Alliance, tells in-Pharmatechnologist.com.
24-Jun-2015 - Naming drugs using active pharmaceutical ingredients (API) rather than their salts will cut down on medication and dosing errors according to the US Food and Drug Administration (FDA).
24-Jun-2015 - The US FDA has seized illegal medicines and medical devices sold by more than 1,050 websites.
23-Jun-2015 - Eli Lilly’s President of Biomedicines says the transatlantic trade agreement TTIP will “force” the FDA and EMA to standardise regulations on manufacturing and trials.
23-Jun-2015 - Generic pills are a safety risk if they are too different from their reference drug according to the US FDA, which wants developers to consider physical characteristics when making copycat meds.
23-Jun-2015 - China is set to become a major vaccines manufacturer for emerging markets once it untangles some regulatory quirks, says a panel at BIO 2015.
23-Jun-2015 - Industry efforts set up a drug database to help Europeans identify fake pharmaceuticals progressed this week after thee software firms signed development deals with project leader, EMVO.
23-Jun-2015 - Health Action International (HAI) has set up an office in Brussels, Belgium in a bid to further influence European pharmaceutical policy and improve access to medicines and public health.
22-Jun-2015 - As the death toll from MERS in South Korea edged to two dozen scientists there say the outbreak is different from in Saudi Arabia and also from its the related virus SARS.
18-Jun-2015 - EMA guidance on process validation for drugmakers is the latest update in cGMP regulations to manage a pharma world shifting from chemical to biological processing, says NNE Pharmaplan.
18-Jun-2015 - Ex-Allergan CEO David Pyott has spoken of his “total war” battling Valeant’s failed hostile takeover, and given advice to other pharmaceutical companies on how to deal with activist shareholders.
17-Jun-2015 - Rumoured Big Pharma takeover target GSK has invested $95m to set up an cell genetics research institute to help developers better identify drug candidates.
17-Jun-2015 - The pharma industry must fight “vendor indifference” so suppliers and services companies are not prey to cyber attacks that can lose drug companies hundreds of thousands of dollars in minutes, according to US Homeland Security’s former head of cybercrimes Mark Weatherford.
16-Jun-2015 - Trade secrets proposals supported by the European Parliament’s legal affairs committee could allow drugmakers to withhold trial results and drug safety data says Health Action International.
16-Jun-2015 - A new trial model is needed to encourage cardiovascular disease drug development say researchers who claim the large, lengthly studies used to prove safety and efficacy of such drugs are a disincentive.
16-Jun-2015 - Health Canada has issued Hospira with an import ban over concerns about a testing lab at its manufacturing facility in Liscate, Italy.
15-Jun-2015 - Drugmakers will be able to upload drug safety data to a single website from next year after a database developed by the EMA has been deemed fit for purpose by independent auditors.
15-Jun-2015 - PatientsLikeMe says a deal allowing the US FDA to use its patient-generated data is an “unprecedented step toward enhancing post-market surveillance.”
12-Jun-2015 - A Jubilant HollisterStier sterile manufacturing facility hit with a warning letter in 2013 has been upgraded following inspections by the US FDA last year.