EU Drug Regulators Urge SMEs To Seek Scientific Advice 'Again And Again'
EMA's Small and Medium-Sized Enterprises Office has 1,450 companies registered, but many are still daunted about approaching the agency.
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The European Commission has granted a marketing authorization for UCB and Amgen’s bone-building MAb, romosozumab, and first launches are expected in the first half of 2020; patient groups suggest that the prevention and treatment of fragility fractures has not attracted the attention it deserves.
Turku, Finland-based Forendo Pharma has entered into a license and collaboration deal with Novartis involving the identification of novel drugs to treat chronic liver diseases.
A PFS benefit and favorable tolerability profile associated with AstraZeneca’s BTK inhibitor acalabrutinib used first-line in CLL, when given alone or combined with obinutuzumab, may serve it well against entrenched competitors and BTK inhibitors in clinical development.