30-Jun-2016 - An oncology centre to support the Moonshot Initiative, conflict-of-interest guidance and calls to become independent. Welcome to in-Pharmatechnologist’s US FDA round-up.
29-Jun-2016 - Set standards for Phase I trials could stop serious adverse events and patient deaths, says a DIA panellist discussing the recent Bial trial tragedy.
28-Jun-2016 - The Swiss drugs regulator saw a near-doubling in the number of inspections prompted by complaints or suspected infringements in 2015, according to its latest annual report.
28-Jun-2016 - Indian companies in the UK are among many in the pharma industry facing an uncertain future after Britain voted to exit the single-market last week.
24-Jun-2016 - Japan “welcomes innovation” as it makes significant investments in infrastructure and regulatory changes.
24-Jun-2016 - The UK biosimilars industry has urged the Government to push for a single marketing authorisation in its upcoming negotiations with the EU, following today’s shock Brexit result.
23-Jun-2016 - Automated systems and reducing hiring time will be crucial in revamping the US FDA’s “antiquated” HR systems, says Commissioner Robert Califf.
23-Jun-2016 - India has withdrawn a proposed amendment to its drug laws after deciding a more extensive rewrite is needed to allow the effective regulation of biologics, regenerative medicines and clinical trials.
22-Jun-2016 - Czech regulators say three drug wholesalers have “seriously violated” good distribution practices (GDP) guidelines.
22-Jun-2016 - The US FDA has approved Opko Health’s kidney disease drug Rayaldee, delayed by almost three months due to manufacturing concerns at its CMO Catalent.
21-Jun-2016 - Scancell Holdings has stopped dosing in a long-term extension arm of a trial of its cancer vaccine SCIB1 after discovering the product is no longer within original specification.
20-Jun-2016 - Clinical trial sponsors are required by law to report results to ClinicalTrials.gov; however it’s not clear if these posts are complete and accurate.
20-Jun-2016 - The US FDA has drug manufacturer Cheryl Laboratories from shipping products to the US after the CMO stopped inspectors from visiting its facility in Navi Mumbai, India.
16-Jun-2016 - Indian regulator CDSCO is developing a new Drug and Cosmetics Act that is more in keeping with the modern pharmaceutical industry.
15-Jun-2016 - The Taiwanese drugmaker stopped shipping products to the US after an FDA inspection but failed to commit to corrective actions, states a warning letter published this week.
14-Jun-2016 - French authorities have started a manslaughter investigation in connection with a Ph I trial conducted by Rennes-based CRO Biotrial in which one volunteer died and five others were hospitalised.
13-Jun-2016 - CDSCO has renewed a number of API firms’ ‘written confirmation’ documents – which are needed to ship to Europe – days after an industry group called for renewals without re-inspection citing trade concerns.
13-Jun-2016 - The UK MHRA has identified GMP deficiencies at an Akums Drugs & Pharmaceuticals facility in India that was being lined up to make progesterone for Nordic Pharma.
13-Jun-2016 - Expect industry guidance on product communication soon says US FDA Commissioner Robert Califf, though a more pragmatic approach to social media will be taken.
09-Jun-2016 - With the emergence of the empowered patient, the reimbursement landscape is shifting and stakeholders must navigate who really holds the power – and how this changes the definition of value.
09-Jun-2016 - Risk algorithms and international agreements will help ensure imported API quality, says FDA Commissioner Robert Califf but industry must also take responsibility for its own supply chain.
08-Jun-2016 - Parties negotiating TTIP have discussed measures that would end EMA API and drug manufacturing plant inspections in the US and FDA inspections in Europe.
08-Jun-2016 - Teva has confirmed it stopped making all but two sterile injectable drugs at its plant in Godollo, Hungary in January after a US FDA inspection.
07-Jun-2016 - The EU will be a more attractive place to test drugs when the EMA clinical trial portal goes live in 2018 according to industry group EUCROF.
06-Jun-2016 - A revised concept paper on first-in-human trials will be ready next month according to the EMA which is reviewing the French Phase I trial in which one volunteer died in January.