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UK generics makers and MHRA pool manufacturing knowledge

23-Apr-2014 - The British Generic Manufacturers Association (BGMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) will launch a forum for the generics industry to discuss manufacturing and quality issues.

Hospira announces two US recalls due to manufacturing, supplier issues

22-Apr-2014 - Hospira has announced US recalls for seven lots of its propofol injection and one lot of 1% Lidocaine HCI Injection due to a glass contamination.

Anti social? Big Pharma balks at US FDA social media guidance

17-Apr-2014 - Comments from Novartis, Eli Lilly and Pfizer revealed that industry is taking serious issue with some aspects of the draft guidance from the US FDA on social media and promotional materials online.

Discovery of tampered vials leads to Roche cancer drug recall

16-Apr-2014 - Roche has recalled nine batches of breast cancer drug Herceptin after tampered vials were discovered in the UK, Finland and Germany.

USCC: making sure Chinese APIs are safe is “hopeless task” for US FDA

14-Apr-2014 - Inspecting the thousands of Chinese factories making APIs for the US market is a “hopeless task” even if the FDA gets the extra staff it wants according to a Congressional committee review.

UPDATE

Sugar in place of APIs discovered in EU's largest fake drug seizure

14-Apr-2014 - Fake aspirin and anti-diarrhoeal medicines were amongst the largest counterfeit drugs haul discovered to be destined for the European Union, a French customs official says.

EMA requests more stability data for some manufacturing changes

14-Apr-2014 - Drugmakers in the EU making changes to their manufacturing processes will have to submit additional stability data, according to a new EMA (European Medicines Agency) guideline.

Canton Labs hit with US FDA Import Alert at Indian API plant

11-Apr-2014 - The US FDA has banned imports of drug products made at Canton Laboratories’ Baroda, India plant weeks after the plant was pulled up for data failures.

Tamiflu spat: Roche ‘disingenuous,’ say review authors

10-Apr-2014 - Roche has clashed with the authors of a report slamming the efficacy of Tamiflu, each claiming the other’s analysis of patient data is seriously flawed.

Governments urged to rethink stockpiling after Tamiflu and Relenza reviewed

10-Apr-2014 - Tamiflu shortens the duration of influenza symptoms by only half a day, does not stop person-to-person spread and increases the risk of nausea say the authors of a new review who want Governments to rethink stockpiling neuraminidase inhibitors.

EU and Aus to share resources in 'time-saving' orphan drug approval

08-Apr-2014 - The EMA and TGA have agreed to share full assessment reports related to marketing authorisations of orphan drug in the latest regulatory collaboration intended to save time and resources.  

WHO calls for more industry invesment in tick-borne disease treatments

07-Apr-2014 - Better data on the global burden of tick-borne illnesses may encourage profit driven drugmakers to spend their R&D budgets on much needed treatments says the WHO.

All clinical trials to be published under European law

03-Apr-2014 - Pharmaceutical companies will be made to publish all European clinical trials in a public database under a draft law passed by the European Parliament yesterday.

US FDA issues import alert on Apotex’s Indian API facility

03-Apr-2014 - The US FDA has banned generic drugmaker Apotex from importing drugs made at its plant in Bangalore, India after discovering GMP violations.

Counterfeit crackdown: EDQM launches fake drug database

02-Apr-2014 - Collating drug counterfeiting cases from across Europe into a central database will help law enforcement authorities catch criminals trying to flood the region with fake medicines, according to the EDQM.

News in brief

Hikma's NJ plant given the all clear from the US FDA

02-Apr-2014 - Hikma has received a close-out letter for its oral manufacturing facility in New Jersey, two years after the US FDA issued a warning.

Politicians spar over US FDA proposed rule for generic manufacturers

02-Apr-2014 - With generic drugs covering 80% of all dispensed drugs in the US, Democrats and Republicans seem split over a proposed FDA rule that would allow generic manufacturers to submit labelling changes within 30 days after discovering a new adverse event or safety issue.

UPDATE

GSK issues recall after Irish API plant slammed by US FDA Warning Letter

01-Apr-2014 - GlaxoSmithKline has issued a recall of its antidepressant drug Paxil after receiving a US FDA Warning Letter for failing to fully investigate contamination issues at an Irish API plant.

Dispatches from DIA Euromeeting

Expert: ‘We lack the regulatory models’ for next generation drugs

01-Apr-2014 - The pharmaceutical industry lacks the regulatory models to govern sweeping changes in the near future surrounding combination products and large molecule drugs, said an expert at DIA Euromeeting in Vienna last week.

Portable tech advancing fight against counterfeits, says MHRA

01-Apr-2014 - Making API detecting technologies more portable has been a major development in the fight against counterfeit drugs, according to the MHRA, though the biggest threat comes from online sellers.

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