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Adalvo waiting EC’s marketing authorization for Livogiva

Pharmaceutical company Adalvo today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for Livogiva, indicated for use in postmenopausal women with osteoporosis who are at high risk of having bone fractures.

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Tiziana Life Sciences Announces Agreement with STC Biologics for GMP Manufacturing of an anti-Interleukin-6-Receptor Monoclonal Antibody for Clinical Studies in Patients with COVID-19

Tiziana Life Sciences today announced the execution of an agreement with STC Biologics, Inc. (“STC”) for GMP manufacturing of TZLS-501, an anti-IL-6 receptor (anti-IL-6R) monoclonal antibody (mAb) acquired from Novimmune in 2017, currently in agreement with Bristol Myers Squibb (BMS).

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CHMP Grants Positive Opinion for Kaftiro + Kalydecofor cystic fibrosis patients with the most common genotypes

Vertex Pharmaceutical said on Friday in a press release that, if Kaftrio combined with Kalydeco is granted Marketing Authorization, people ages 12 and older in Europe who have one F508del mutation and one minimal function mutation will for the first time be able to benefit from a medicine that treats the underlying cause of the disease.

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Novartis Resolves Legacy FCPA Investigations

Novartis has reached settlements with the US Department of Justice (DOJ) and the US Securities and Exchange Commission (SEC) resolving all Foreign Corrupt Practices Act (FCPA) investigations into historical conduct by the Company and its subsidiaries. As part of the settlements, Novartis and certain of its current and former subsidiaries will pay USD 233.9 million to the DOJ and USD 112.8 million to the SEC.

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