CHMP with new Chair – 13 meds recomm...The CHMP elected Harald Enzmann as its new Chair on Friday, and recommended thirteen medicines for approval, three thereof orphan medicines. more ➔
European biotech companies enter IPO prep...European stock exchange operator Euronext kicked off its fourth annual capital markets training programme for non-listed companies – this time also including companies from Germany, Italy, Spain, and … more ➔
Novo Nordisk reveals details about its R&#...Novo Nordisk A/S (NOVOB:DC) said it plans to restructure its entire Research & Development (R&D) organization. Consequently, the company will lay off 400 employees from R&D roles in Denmark … more ➔
Pharming receives complete response letter...The FDA has requested additional clincal data demonstrating that Pharming Group’s recombinant C1 esterase blocker Ruconest can prevent hereditary angioedema attacks (HAE). more ➔
CRISPR Therapeutics and Viacyte launch dia...CRISPR Therapeutics AG announced a development partnership with ViaCyte Inc to develop genome-edited pancreatic islet cells, which do not require immunosuppression, to treat diabetes. more ➔
Sanofi preparing label extension for dupil...Positive Phase 3 results with Sanofi/Regeneron’s IL4/IL-13-targeting antibody dupilumab (Dupixent) in adolescents with moderate-to-severe atopic dermatitis will form the basis of a regulatory … more ➔
Calcium does not contribute to heart failu...Slowing the leak of Calcium leak into cardiomyocytes does not improve the pumping malfunction in heart failure, German cardiologists report in Science Translational Medicine. more ➔
Boehringer Ingelheim bags ViraT in €210m...EMBL Ventures has announced that its portfolio company ViraTherapeutics is set to be acquired by Boehringer Ingelheim in a €210m million (US$245m) transaction. more ➔
EU approves Shire’s van Willebrand f...Orphan drug leader Shire plc has been granted EU marketing authorization for its recombinant van Willebrand factor (rVWF) vonicog alfa as second-line treatment for van Willebrand disease, the most … more ➔
PD1/PD-L1blockers trigger metastasesDrug Developers dealing with PD1-PDL1 checkpoint inhibitors must consider new safety problems associated with the hyped cancer meds. more ➔
