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Trial transparency: NICE stands firm on data

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.

EMA guideline on pharmacovigilance inspections comes into effect

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.

EC rejig will see DG Enterprise and Industry take responsibility for EMA

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.

Drug prices will continue to vary accross Africa says analyst

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.

@MHRA: regulators could track #drug reactions via Twitter

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).

Industry groups take issue with FDA draft guidance on outsourcing facilities

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.

$20m Andromeda strains Hyperion as fake data ends diabetes drug development

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.

MHRA and Novartis lead consortium to develop adverse drug reaction app

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.

ISPE offers preview to drug shortages prevention plan

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.

Ben venue fallout continues to cause headache for Boehringer Ingelheim

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.

TransCelerate recommends what to protect in trial transparency efforts

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.

Find other oral forms for tablet-hating patients, drugmakers told

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.

Stem cells made available for API development by European biobank

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.

Gangsters imported fake drugs from Asia says Europol

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. 

Compounding the problem: US warns two more pharmacies

01-Sep-2014 - The US FDA has criticised the Compounding Shop and Zion Rx Formulations Services for making unapproved and contaminated drugs.

US FDA 2009 import ban legal NAFTA panel tells Apotex

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.

US claims Dr Reddy’s broke safety packaging rules for 4 years

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.

USP joins campaign against illegal online pharmacies

26-Aug-2014 - Drug quality and standards organisation USP has joined a campaign to raise awareness about the risks posed by illegal online pharmacies.

Argentina to allow Indian drug imports after inspecting five plants

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.

Claris gets MHRA OK for injectables plant

21-Aug-2014 - Indian manufacturer Claris Lifesciences has had its injectable drug manufacturing facility in Ahmedabad approved by the UK MHRA.

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