Hungary

Hungarian leader Gedeon Richter spoke at length of its recent European roll-out of generic competition to Bayer’s Xarelto blockbuster, while also providing key updates for its biosimilar pipeline, as the firm reported financial first-half results.

Gedeon Richter is looking to chart its own path in women’s healthcare and expand its global footprint, after buying up a bundle of businesses and key products and pipeline assets from Belgium’s Mithra.

With two M&A deals expected to close in the second quarter, Gedeon Richter counts its wins and losses from a “solid” start to the year.

While investigating the potential of the Japanese market for its denosumab, Gedeon Richter is preparing for several regulatory filings, including its tocilizumab biosimilar.

Fledgling biosimilars player Gedeon Richter has spoken candidly and openly with investors on its recent biosimilar investments, its goal to start generate cash from its young Biotech business, and its need to manage costs in order to make that happen.

Gedeon Richter is putting its hand back in its wallet following its recent investment in Formycon, opting to take control of a pair of joint ventures established with German firm Helm.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Ceres Pharma will grow its presence in Hungary, adding consumer health brands including 1x1 Vitamin and Innopharm supplements and Medistus medical devices, through its acquisition of Budapest's VitaPlus.

The proposed European Health Data Space aims to enable the seamless transition of health data sharing for certain purposes across the EU. A new report highlights how national variations in data storage and budgetary constraints may affect the initiative’s success.

The latest notified body listing brings total number of EU designated Medical Device Regulation testing and certification organizations to 35.