FDA Grants Priority Review for Genzyme’s Cerdelga

US regulatory body, the Food and Drug Administration (FDA), have announced that they will be undertaking an accelerated a review of Sanofi’s Genzyme unit’s Gaucher disease drug, Cerdelga (eliglustat), having granted a six-month priority review for the application. Gaucher disease is a genetic disorder where lipids build up in cells and certain organs, causing problems

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NICE Requests Further Information on Genzyme’s Lemtrada

The regulatory body for the NHS in England and Wales has requested additional information from Genzyme prior to making a decision on the submission of Lemtrada. The National Institute for Health and Care Excellence (NICE) are currently unlikely to recommend the use of Genzyme’s Lemtrada (alemtuzumab) for relapsing, remitting multiple sclerosis, as a result of

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Tresiba and Ryzodeq Approved by EU Regulators

European regulators have approved Novo Nordisk’s Tresiba and Ryzodeg, which Novo hopes will challenge Sanofi’s Lantus, the largest selling insulin product globally. The European Commission have granted marketing authorisations for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) for the treatment of diabetes in adults.

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Sanofi Job Cuts Lower Than Expected

Sanofi have revealed details regarding their intended job cuts in France which are expected to affect 900 people, and currently appear to be a lot lower than the numbers that had been rumoured. The Paris-based organisation has announced “a project for the adaptation of its activities in France through 2015.”  They now plan to begin

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Sanofi Job Cuts Backed by French Minister

With Sanofi expected to be near to announcing the number of planned job losses in France, and worker protests increasing, the Paris-headquartered organisation have received unexpected support from a French government minister. In July this year, Sanofi announced that they planned to cut jobs at two French sites with the aim to protect the organisation’s

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Sanofi Announces Mixed News for Zaltrap

Sanofi and Regeneron have announced varied fortunes for their cancer drug Zaltrap, with the drug gaining a quick evaluation in the USA for colorectal cancer, but failing in a late-stage prostate cancer clinical trial. Sanofi announced today that the US Food and Drug Administration (FDA)  has granted priority review of the Biologics License Application for

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Lantus Does Not Increase Cancer Risk, Claims Sanofi

Sanofi yesterday presented new data which they say supports the safety profile of their blockbuster drug, Lantus, hours after dismissing claims from a study that using the diabetes treatment more than doubled the risk of developing cancer. The French giant unveiled new meta-analysis data at the World Diabetes Congress in Dubai, which they say adds

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Sanofi Announces Positive Phase III TEMSO Results

Sanofi and their subsidiary Genzyme announced the publication of their pivotal Phase III TEMSO (Teriflunomide Multiple Sclerosis Oral) study with investigational once-daily oral medication teriflunomide in The New England Journal of Medicine (NEJM). The results showed that teriflunomide, at the 14mg dosage, significantly reduced the yearly relapse rate, reduced disability progressions and improved numerous magnetic

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Study finds that Gardasil is ‘More Cost Effective’ than Cervarix

According to new data published in the British Medical Journal, the cervical cancer vaccine, Gardasil, produced by Merck and Sanofi, may be more cost effective than its competitor GlaxoSmithKline’s Cervarix. However, the differential benefits of both vaccines remain unclear, say researchers from the Health Protection Agency. The study has been updated from the one previously

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