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- Comments from Novartis, Eli Lilly and Pfizer revealed that industry is taking serious issue with some aspects of the draft guidance from the US FDA on social media and promotional materials online.
16-Apr-2014 - Roche has recalled nine batches of breast cancer drug Herceptin after tampered vials were discovered in the UK, Finland and Germany.
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.
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.
14-Apr-2014 - New appointments at biopharma and equipment companies also feature in this week's column.
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.
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.
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.
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.
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.
07-Apr-2014 - The EMA (European Medicines Agency) has cut what it charges small and medium-sized enterprises (SMEs) and micro businesses to help them comply with regulations once their drugs are approved.
07-Apr-2014 - Regulatory compliance will be the number one focus for Sun Pharma, the company says, following its $3.2bn (€2.3bn) takeover of Indian generics firm Ranbaxy.
07-Apr-2014 - Plus other people on the move in the pharma industry in this week's column.
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.
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.
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.
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.
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.
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.
31-Mar-2014 - In light of the implementation of the Drug Quality and Security Act of 2013 in the US, which calls for the phased implementation of electronic tracking down to the package level, companies are looking at options to catch up and reduce counterfeiting at the same time.
31-Mar-2014 - People are on the move at Baxter, Merck & Co., Johnson & Johnson, and elsewhere in this week's column.
27-Mar-2014 - GlaxoSmithKline has issued an alert and US voluntary recall of its OTC weight-loss drug Alli after discovering some bottles had been tampered with.
26-Mar-2014 - Pharmaceutical firms working in Europe may need to update their address books next month after more reorganisation at the EMA.
24-Mar-2014 - New hires at Merck Serono, Amgen, Takeda and Fate Therapeutics this week. It's in-Pharmatechnologist.com's people column.
20-Mar-2014 - The UK Medicines and Healthcare Products Regulatory Agency (MHRA) will launch a scheme next month to allow doctors to prescribe medicines without a marketing authorisation to patients with life-threatening conditions.
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