04-Aug-2016 - The US National Institutes of Health (NIH) has permanently halted trial drug production at a site where cGMP violations were identified last year.
03-Aug-2016 - The US FDA says Xiamen Origin Biotech Co. lied to investigators during an inspection of its API facility in Fujian in which significant deviations from cGMP were identified.
02-Aug-2016 - Keryx Biopharmaceutical's CMO has halted production of Auryxia (ferric citrate) as a results of manufacturing problems.
02-Aug-2016 - Jinan Jinda Pharmaceutical Chemi has not fixed GMP deficiencies at its Shandong plant say Spanish regulators calling for ban on nitrofurantoin shipments to the EU.
28-Jul-2016 - US FDA warnings and Venezuela's economic crisis have contributed to “a challenging quarter” for Dr Reddy’s, with its API business being particularly affected.
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 - 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 - 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 - 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.
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.
13-Jul-2016 - The EMA has started assessing some drugs made by Pharmaceutics International Inc (Pii).
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 - In-house manufacturing investments have been key to the clinical development of Advaxis’ oncology candidates, the firm says.
29-Jun-2016 - Quality system and data integrity issues have landed two Chinese API makers with US FDA warning letters.
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.
27-Jun-2016 - The pharma industry is underprepared for the upcoming global regulations says Recipharm, which has inked three new tech deals as part of its €40m serialisation effort.
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 - 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.
22-Jun-2016 - AMRI has licensed technology needed to make an analytical standard drug firms working with cannabinoids can use for research and quality control.
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