07-Oct-2014 - The world is getting larger, at least it is in terms of the pharmaceutical industry, according to execs who cite security concerns when shipping to new markets as the top logistics worry.
30-Sep-2014 - Hampered by manufacturing issues, Impax Laboratories has decided to settle a lawsuit over allegations related to the issues in order “to eliminate the uncertainty, distraction, burden and expense of further litigation,” the company said in a SEC filing .
29-Sep-2014 - The US Food and Drug Administration has rejected a petition to force drugmakers to reformulate CNS-acting drugs like Adderall, Ritalin, and painkillers to prevent illegal use, but experts say the rule is only a matter of time.
29-Sep-2014 - The Indian Government has accused the authors of a paper analysing the quality of drugs sold in Africa of leading an attack on the Indian drug industry, but researcher Roger Bate says they are “shooting the messenger.”
29-Sep-2014 - The Chairman who steered the Royal Bank of Scotland Group (RBS) after its financial crisis losses will join GSK’s Board as a Non-Executive Director and...
25-Sep-2014 - An anti-addiction group has called for a change in leadership at the US FDA following the approval of Zohydro and other high-dose opioid analgesics.
24-Sep-2014 - The Pharma industry has responded to the Ebola crisis in West Africa with developmental vaccines and aid donations, but drugmakers still need to be incentivised to develop new therapies according to the WHO.
24-Sep-2014 - As the US Drug Supply Chain Security Act (DSCSA) traceability requirements become mandatory in 2015, standards group GS1 is offering a 137-page guideline to help manufacturers follow the new stipulations.
23-Sep-2014 - GlaxoSmithKline will not restart production at a vaccine plant in Belgium until an independent investigation determines how liquid contaminated with polio virus was released into the local sewage system.
23-Sep-2014 - The US Food and Drug Administration (FDA) says compounding pharmacies must not manufacture medicines for hospitals and doctors’ offices, except for named patients.
22-Sep-2014 - The US National Institutes of Health (NIH) is collecting photos of pills and tablet in a database for use in apps to improve public safety.
18-Sep-2014 - Use of the muscle relaxant atracuriam to resuspend freeze-dried measles vaccines instead of the proper diluent almost certainly caused the death of more than a dozen Syrian infants according to the WHO.
18-Sep-2014 - After much discussion and some confusion , the ICH’s (International Conference on Harmonization) Q3D guideline , which will govern elemental impurities in final drug products, is expected to be finalized at the end of this month.
17-Sep-2014 - The US FDA has warned the public not to use any sterile medicines made by Downing-owned NuVision Pharmacy, Texas, which failed to comply with a recall order.
17-Sep-2014 - Shifting EMA oversight to DG Enterprise and Industry will put patients at greater risk of adverse events according to NGO Health Action International, which suspects EFPIA “had a hand” in planned European Commission reshuffle.
16-Sep-2014 - The UK’s NICE says it will go over drug companies’ heads and get clinical trial data from regulators if sponsors fail to supply their results.
16-Sep-2014 - As the EMA has announced that the main objectives of its pharmacovigilance legislation are largely being achieved , the agency is still implementing a number of the individual modules that make up the over-arching law.
15-Sep-2014 - The EU commission plans to strip DG Sanco of responsibility for the running the European Medicines Agency (EMA) and hand it to the directorate in charge of enterprise and industry.
15-Sep-2014 - Hospira has pulled a lot of heparin sodium after human hair discovered in vial.
15-Sep-2014 - Who's in, who's out: all the latest changes in senior pharmaceutical appointments.
11-Sep-2014 - High importation costs and country-to-country differences in national healthcare systems mean drugmakers will continue to vary the cost of products in Africa according to an industry analyst.
11-Sep-2014 - The UK Medicines and Healthcare products Regulatory Agency (MHRA) says Twitter, Facebook and smartphone apps could soon be used to gather adverse drug reactions (ADRs).
10-Sep-2014 - A new list of biopharmaceuticals published by the US FDA provides limited information with only the entries for Neupogen, Perjecta and Granix including expiry dates.
09-Sep-2014 - Hyperion says it is “shocked and disheartened” after discovering Phase III trial data for a type 1 diabetes candidate was manipulated by employees of recently acquired Andromeda Biotech.
Almac’s subsidiary Galen has licensed UK sales and marketing rights to an emergency pain drug nicknamed the...
The UK’s NICE says it will go over drug companies’ heads and get clinical trial data from...
Mannkind says Sanofi could become a second API supplier for its recently approved inhalable insulin drug Afrezza...
High importation costs and country-to-country differences in national healthcare systems mean drugmakers will continue to vary the...
Hyperion says it is “shocked and disheartened” after discovering Phase III trial data for a type 1...
The International Society for Pharmaceutical Engineering (ISPE) last week offered up a preview to its plan to...