Archive for the 'Europe News' Category

EC Releases Revisions of GMP Guidelines

The European Commission (EC) has released the draft revision for four chapters of its good manufacturing practice (GMP) guidelines—chapters 3, 5, 6 and 8.  A public consultation was launched earlier this year with comments due on 18 July 2013. The EC stated that these revisions were needed to reflect the latest thinking relating to best practices. Read more »

NICE Responsible for UK’s Value-Based Pricing of Medicines

The UK government has confirmed that from 2014 onwards, the National Institute for Health and Clinical Excellence (NICE), which is the country’s cost-effectiveness watchdog, will play a central role in the new value-based pricing system for assessing the costs and benefits of medicines. Read more »

Janssen and NHS Collaborate on Dementia Challenge

Janssen is partnering with the UK National Health Service (NHS) on a new programme that seeks to inspire innovative ideas that will help reshape and improve the way dementia care is delivered. The company recently launched the inaugural NHS innovation challenge prize for dementia, which is designed to harness the expertise of those working at the frontline of dementia care in the UK. Janssen is offering a prize of up to £150 000 for solutions that can make a real and sustained difference to the lives of those affected by dementia, both directly and indirectly. Read more »

Combined Oral Contraceptives Sparks Safety Review

There are growing concerns regarding the safety of third- and fourth-generation combined oral contraceptives following media reports on blood clots (venous thromboembolism) associated with the use of more recently-introduced contraceptive products containing newer progestins such as drospirenone, gestodene and desogestrel. France has requested that the European Medicines Agency (EMA) review this class of drugs to determine if their use should be restricted. This is the first time that a member state has requested the EMA to give an EU-wide recommendation for these medicines under the framework of the new pharmacovigilance legislation. Read more »

Pharma 2012 Layoffs


2012 European Outsourcing Award Winners

The 2012 European Outsourcing Awards—what some call the “Outsourcing Oscars”—were presented on October 10, 2012 during the CPhI Worldwide/iCSE show and included awards to Vetter for a high-speed filling line and to Catalent for updates to its controlled-release facility. Read more »

Roche Under EMA Investigation

Stephanie Sutton Pharm Tech EuropeEarlier this year in June, Roche’s name hit the headlines after a pharmacovigilance inspection discovered around 80000 safety reports that had not been evaluated by the company to determine whether they should be reported as adverse drug reactions. Included in the reports were approximately 15161 deaths, although the European Medicines Agency explained at the time that the actual number of reports could be lower once verified. EMA also added that the deaths may not have a casual link to the medicine. Either way, it’s still a huge number of reports that should have been assessed.

Today, the case accelerated as the European Medicines Agency launched an infringement procedure against Roche to investigate the alleged pharmacovigilance deficiencies. Read more »

Bayer Force One, Part II: Around the World with Solar Power

Earlier this year, the concept of solar-powered aviation was further propelled from its proverbial runway, testing many limits that had not been previously realized in the realm of energy-efficient transportation. However, as is the case with virtually every achievement since the dawn of civilization, the question remains the same: Where do we go from here?

From May–July 2012, Solar Impulse—with the help of several sponsors, including Bayer MaterialScience, the subsidiary of the pharmaceutical manufacturer Bayer—successfully completed a series of flights (known as Crossing Frontiers) as part of a round-trip journey from Switzerland to Morocco, setting several world records, according to the World Air Sports Federation, in the solar-powered subcategory (including for free distance along a course, and for straight distance with predeclared waypoints). In addition, the mission included the first solar-powered intercontinental flight linking Europe to Africa when Solar Impulse’s HB-SIA plane crossed the Strait of Gibraltar.

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Stepping Away From the Patent Cliff

Amy RitterIn a bit of good news for pharma, Moody’s Investors Service has upgraded its outlook for the global pharmaceutical industry to stable. The Moody’s rating reflects expectations for fundamental business conditions in the industry over the next 12 to 18 months, and until now, the industry had been limping along under a negative outlook assigned back in October 2007. According to a statement from Moody’s, the change in status reflects the fact that worst of the revenue drops caused by blockbuster drugs falling off patent are over, and so earnings are expected to stabilize. Read more »

Why Sanofi’s Recent Job Cuts Could be Worse

Stephanie Sutton Pharm Tech EuropeYesterday, Sanofi issued a press statement titled “Sanofi provides information on the adaption of its activities in France through 2015.” Read past the headline and you quickly realise that the ‘adaption of activities’ involves eliminating around 900 jobs at the company’s sites France by 2015. You can read the statement here.

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