23-Feb-2017 - Several organizations have penned an open letter to NIH urging it adhere to 21st Century Cures deadlines that if missed, will affect improvements to ClinicalTrials.gov – and ultimately, study start up.
22-Feb-2017 - Vaccines do not cause autism and people who say otherwise are wrong.
21-Feb-2017 - A radiopharmaceuticals plant is the most likely source of the radioactive iodine-131 detected in several countries in recent weeks according to experts.
20-Feb-2017 - Takada Pharma A/S has recalled a batch of its Pamol paracetamol tablets in Denmark after two packs were found to contain ibuprofen.
20-Feb-2017 - Medical marijuana developer Tilray has begun shipping to overseas patients and trial sites outside Canada after partnering with local distributors to comply with regional regulations.
20-Feb-2017 - The US FDA has issued a warning letter to the former Hospira fill and finish facility in McPherson, Kansas – now part of Pfizer’s contract manufacturing business CentreOne.
16-Feb-2017 - Dr. Reddy’s Laboratories Ltd has said it may invest in additional manufacturing capacity to support its efforts to grow in the European hospital drug market.
15-Feb-2017 - The US FDA says Sato Pharmaceutical Co., Ltd. has not addressed environmental monitoring shortcomings at its Tokyo plant.
13-Feb-2017 - Indian regulators want manufacturers to discourage pharmacists from selling antibiotics to patients without prescriptions as part of an effort to curb the spread of superbugs.
09-Feb-2017 - Sanofi intends to resubmit its licensing application for Kevzara within the next few weeks following subject to a US FDA re-inspection of a French fill/finish plant.
08-Feb-2017 - Denmark has bid to be the new home of the European Medicines Agency (EMA) after the UK leaves the European Union.
06-Feb-2017 - If reinstated, Donald Trump’s order restricting travel to the US would hurt the cell therapy sector according to the International Society for Cellular Therapy (ISCT).
06-Feb-2017 - Banned wholesaler Europharma DK has appointed a new CEO and hired Abacus Medicine to repackage and distribute drugs on its behalf.
01-Feb-2017 - Spanish regulators have criticised operations at a facility operated by vaccine firm Euro Far Alergi S.L.
31-Jan-2017 - Data integrity issues have landed Italian drugmaker FACTA Farmaceutici with a US FDA warning letter.
31-Jan-2017 - The European Commission has approved oral formulation of Novartis' seizure treatment Everolimus under the trade name Votubia.
26-Jan-2017 - The GMP certification of a Dutch cannabis production facility is a “major step” in bringing medicinal marijuana to the level of evidence based medicines, says Bedrocan.
25-Jan-2017 - Porton Biopharma says it is undergoing a manufacturing review to address US FDA concerns about the production of Jazz Pharmaceuticals’s orphan drug Erwinaze.
23-Jan-2017 - Ocular Therapeutix Inc. has resubmitted its eye pain drug Dextenza to the US FDA claiming it has solved manufacturing problems that saw the agency reject the drug in July.
23-Jan-2017 - The EDQM has set out how it will integrate risk-based elemental impurities testing into the European Pharmacopoeia.
23-Jan-2017 - ICH is currently seeking public comment on proposed "modernizations" to the clinical trial design, planning, management, and conduct guidelines ICH E8 and E6.
19-Jan-2017 - Czech authorities have ordered B. Braun Medical s.r.o to stop supplying medicines from a warehouse in Rudná after identifying breaches of good distribution practice (GDP) guidelines.
18-Jan-2017 - The US FDA is inspecting more foreign plants but has not shown if its efforts have improved the quality of API and drug imports according to a GAO report.
18-Jan-2017 - The US FDA has criticised Sato Yakuhin Kogyo Co responses to data integrity concerns an inspection team raised after visiting its drug plan last June.
17-Jan-2017 - Problems at a CMO have forced Janssen-Cilag to ship Haldol made in Austria to patients in Switzerland to maintain supplies.