Pharma

191 articles available

The Dutch authorities have handed over to the European Medicines Agency (EMA) its new premises, located in the Zuidas business area of Amsterdam. On 15 November EMA’s Executive Director Guido Rasi …

One of the features that render the European Union’s Supplementary Protection Certificate (SPC) unique in comparison to similar legal instruments in other jurisdictions, including the United States…

In the field of supplementary protection certificates (SPCs) in the European Union, the majority of all CJEU referrals resolved to date have dealt with the interpretation of the – presumably simple –…

Among the flurry of pre-summer vacation judgments coming from the Patents Court is one from Mr Justice Birss (17 July 2019), concerning the validity of Hoffman-La Roche’s patent EP (UK) 2 007 809. EP…

Pemetrexed, yet again: last Wednesday the District Court of The Hague, swimming against the current and after a deep dive in the prosecution file, decided that Fresenius did not infringe Eli Lilly's …

The focus in The Netherlands on the option of compounding medicines as a means to circumvent the use of (expensive) authorised medicinal products of pharmaceutical companies and to pressurize them…

The legislative procedure introducing an SPC manufacturing waiver in the European Union has been completed today on 11 June 2019 with the publication of the corresponding new Regulation (EU) 2019/933…

 Russian law provides that information on state registration of drugs shall be publicly available. For a long period, MoH used to turn a blind eye to this obligation, keeping information on all filed…

44 U.S. states filed a lawsuit last Friday accusing Teva Pharmaceuticals USA of conspiring illegally with 19 other drug companies to inflate drug prices - sometimes by more than 1,000 percent - and…