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.
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).
11-Sep-2014 - Industry groups BIO (Biotechnology Industry Association) and GPhA (Generic Pharmaceutical Association) are calling for outsourcing facilities to be held to the same standards as other, larger manufacturers.
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.
08-Sep-2014 - The drug industry and regulators have teamed up to develop a smartphone app to make the gathering and reporting of adverse drug reactions easier.
08-Sep-2014 - The International Society for Pharmaceutical Engineering (ISPE) last week offered up a preview to its plan to help manufacturers avoid or mitigate drug shortages due to manufacturing or quality issues.
04-Sep-2014 - Divested sterile manufacturer Ben Venue has continued to cause trouble for Boehringer Ingelheim with a second recall this year of an injectable drug made at the now defunct site.
03-Sep-2014 - Industry group TransCelerate Biopharma has developed a new recommended approach for protecting patients’ personal data in Clinical Study Reports (CSRs) shared with researchers, patients and others as part of plans to release more data under consideration in the EU and US.
02-Sep-2014 - Pharma firms must provide imaginative solid dosage alternatives to tablets and capsules, says research claiming more than half of patients have problems swallowing traditional pills.
02-Sep-2014 - A German biobank has made stem cells available to active pharmaceutical ingredient (API) firms this week in a bid to support industry drug development efforts.
02-Sep-2014 - Millions of fake pharmaceuticals seized earlier today were imported from Asia by an organised crime group that planned to sell them online say European law enforcement agencies that co-ordinated the swoop.
01-Sep-2014 - The US FDA has criticised the Compounding Shop and Zion Rx Formulations Services for making unapproved and contaminated drugs.
01-Sep-2014 - The US FDA import ban imposed on Apotex in 2009 was legal and the firm was not treated more harshly than generics rival Teva according to a State Department arbitration panel.
28-Aug-2014 - Dr Reddy’s Laboratories says accusations by the US Government’s Consumer Product Safety Commission (CPSC) that it violated childproof packaging rules could cause significant losses for the company.
26-Aug-2014 - Drug quality and standards organisation USP has joined a campaign to raise awareness about the risks posed by illegal online pharmacies.
25-Aug-2014 - Argentina decided to allow Indian drug imports after inspecting just five of the country's 793 manufacturing facilities according to documents released this week.
21-Aug-2014 - Indian manufacturer Claris Lifesciences has had its injectable drug manufacturing facility in Ahmedabad approved by the UK MHRA.