16-Nov-2016 - The US FDA has almost cleared a backlog of 4000 excipient formulations in its Inactive Ingredient Database (IID) and wants drugmakers to help ensure ongoing accuracy.
15-Nov-2016 - Manufacturing quality is key for biosimilar success says Pfenex, as the US FDA continues to increase its regulatory oversight.
15-Nov-2016 - The flexibility of clinical development for products on designated accelerated pathways is leading to at-risk investments in commercial manufacturing, say Pfizer and the FDA.
14-Nov-2016 - AAPS 2016 kicked off yesterday with a focus on new technologies, new delivery modalities, accelerated drug development and precision medicines - oh and a microscope on an iPhone.
08-Nov-2016 - The USP has proposed monograph for hypromellose capsule shells used to make vegetarian friendly medicines.
08-Nov-2016 - EAG Laboratories has set up an elemental impurities lab in response to US FDA moves to align testing rules with ICH Q3D guidance and USP requirements.
03-Nov-2016 - Endo International has withdrawn over half a million birth control pills made by contract manufacturer Patheon after tests indicated
02-Nov-2016 - Lonza has opened a drug quality testing and formulation laboratory in Basel, Switzerland.
02-Nov-2016 - Data integrity issues and the unexplained disappearance of drums of pharmaceutical ingredients have landed a Chinese API maker with a US FDA warning letter.
31-Oct-2016 - The US FDA has issued a complete response letter for Sanofi and Regeneron’s rheumatoid arthritis candidate sarilumab due to manufacturing deficiencies at a fill/finish plant in France.
27-Oct-2016 - Development of an EMA and US FDA mutual recognition agreement on drug facility inspections has progressed according to European Commission negotiators who say a deal could be signed by January.
26-Oct-2016 - The US FDA wants more information on Czech API firm Interpharm Praha AS’s efforts to prevent repetition of data manipulation uncovered during 2015 inspection.
24-Oct-2016 - Biotrial has accused French newspaper Le Figaro of leading a “smear campaign” through its coverage of the Phase I trial in which one man died and five others were hospitalised in January.
24-Oct-2016 - APIs made by Laxachem Organics pvt ltd were not the source of bacteria in Pharmatech laxatives linked to a spate of Burkholderia cepacia infections according to the US Food and Drug Administration (FDA).
20-Oct-2016 - The US FDA has warned Teva Pharmaceutical Industries about its facility in Godollo, Hungary over ongoing concerns about manufacturing operations.
19-Oct-2016 - US FDA inspectors found vermin in drug production areas at a manufacturing facility operated by Montana Compounding Pharmacy.
19-Oct-2016 - The US FDA has identified quality control problems at a sterile drug manufacturing facility operated by Akorn Pharmaceuticals.
18-Oct-2016 - Recipharm has said it will spend SEK5m ($567,000) on a bioanalysis laboratory in Sweden citing the lack of capacity in the Nordic region as a driver for the investment.
17-Oct-2016 - The WHO has added side-effect heavy, TB drug ingredient gatifloxacin to its prequalification list to encourage production.
13-Oct-2016 - The US FDA has found a direct link between contaminated water at CMO PharmaTech and a multistate B. cepacia outbreak.
With advances in synthetic biology and a global focus on sustainable manufacturing, microbial fermentation is undergoing a renaissance...