21-Jul-2016 - European authorities want to revise the guidelines covering first-in-human studies in light of the French trial in which one man died and others were hospitalised earlier this year.
19-Jul-2016 - The US FDA has issued Sandoz with a complete response letter for its Neulasta biosimilar.
19-Jul-2016 - Ethical principles for conducting research involving humans were originally detailed in 1978 – today, a new report is urging Congress to make updates to the decades old document.
19-Jul-2016 - A constipation medication made by PharmaTech LLC has been recalled after being linked to an outbreak of the bacteria B. cepacia in five US states.
19-Jul-2016 - Two Chinese and two Indian companies have been banned from importing APIs to the US – one manufacturer says it’s making GMP compliance a “priority.”
19-Jul-2016 - Legal loopholes and poor enforcement let criminals in China divert APIs for illegal drug production according to a US congressional committee which says the country is fast becoming the major global supplier of crystal meth precursors.
19-Jul-2016 - Drug manufacturers seeking approval in India now have 45 days to provide the CDSCO with any supplementary information or the application will be rejected.
18-Jul-2016 - Ziopharm Oncology has started investigating a death that occured during a Ph I trial of its candidate brain cancer gene therapy, Ad-RTS-hIL-12.
15-Jul-2016 - The US FDA’s decision to let Juno Therapeutics restart its JCAR015 trial is positive, but the CAR-T sector must learn from safety and efficacy findings says French biotech TxCell.
14-Jul-2016 - The FDA has issued two new guidances as part of the President’s Precision Medicine Initiative.
13-Jul-2016 - Senior leadership from key regulatory bodies gathered at the DIA 2016 Annual Meeting to discuss challenges they face as global regulators, both domestically and as part of international cooperative initiatives.
13-Jul-2016 - The EMA has started assessing some drugs made by Pharmaceutics International Inc (Pii).
11-Jul-2016 - In their pursuit to apply criminology theory to counterfeit medications, Nigerian leaders faced death, says researcher – but the country's efforts have ultimately been successful.
11-Jul-2016 - After announcing a new pricing model that promises transparency, affordably, and reasonable return, KaloBios has emerged from bankruptcy – but transparency moving forward will be a shared burden.
11-Jul-2016 - With deadlines around the corner, companies are beginning to plan their serialization initiatives – a process defined by regulatory changes, says Antares Vision.
07-Jul-2016 - Compliance consultant Sequence Inc. has partnered with software firm Adents to develop a track & trace solution for pharmaceutical products.
05-Jul-2016 - Almost one in five active pharmaceutical ingredient (API) facilities inspected by the European Directorate for Quality of Medicines and Healthcare (EDQM) last year failed to meet quality standards.
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.
29-Jun-2016 - Quality system and data integrity issues have landed two Chinese API makers with US FDA warning letters.
Amino Acid Analysis in general can be used for identification testing of biopharmaceutical active ingredients and the determination of...
It is well known that implementation of Rapid Microbiological Methods in Pharma environments is accompanied by a large validation work...