28-Jul-2016 - Scientists at AstraZeneca’s former R&D site in Alderley Park will play a key role in researching antibiotics and the spread of resistance under an initiative launched by US President Barack Obama.
26-Jul-2016 - The European Medicines Agency (EMA) has released a concept paper proposing changes to its current guidance on first-in-human clinical trials.
26-Jul-2016 - The US FDA says it identified “significant deviations” from manufacturing standards a facility in Denmark operated by allergy immunotherapy developer ALK-Abello (ALK).
26-Jul-2016 - The US FDA will not approve the candidate eye pain eye treatment Dextenza until developer Ocular Therapeutix addresses concerns about how the product is made.
25-Jul-2016 - Sandoz is repeating bioequivalence studies and Teva is withdrawing an antimalarial after the EMA recommended that drugs trialled by Semler Research Centre should be suspended.
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.
21-Jul-2016 - GSK will recall more antibiotics made at a UK API unit that has been offline since the US FDA raised contamination concerns last 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 - 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 - Bayer has continued talks with agri-giant Monsanto over the past several weeks, upping its previous offer to the company.
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 - The Council of the EU has unveiled a plan to analyse the competitive landscape for pharmaceuticals in Europe in a bid to improve patients' access to medicines.
06-Jul-2016 - UK biopharma company Scancell was forced to halt trials of its flagship cancer immunotherapy SCIB1 because its supplies of the drug no longer meet quality specifications.
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.