CHMP with new Chair 13 meds recommended
European biotech companies enter IPO prep course
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 Switzerland.
Novo Nordisk reveals details about its R&D transformation
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 and China.
Pharming receives complete response letter from FDA
The FDA has requested additional clincal data demonstrating that Pharming Group’s recombinant C1 esterase blocker Ruconest can prevent hereditary angioedema attacks (HAE).
CRISPR Therapeutics and Viacyte launch diabetes partnership
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.
Sanofi preparing label extension for dupilumab
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 submission in this new patient population, according to announcements of Sanofi.
Calcium does not contribute to heart failure
Slowing the leak of Calcium leak into cardiomyocytes does not improve the pumping malfunction in heart failure, German cardiologists report in Science Translational Medicine.
Boehringer Ingelheim bags ViraT in 210m deal
EMBL Ventures has announced that its portfolio company ViraTherapeutics is set to be acquired by Boehringer Ingelheim in a 210m million (US$245m) transaction.
EU approves Shire’s van Willebrand factor
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 common blot clotting disorder..
PD1/PD-L1blockers trigger metastases
Drug Developers dealing with PD1-PDL1 checkpoint inhibitors must consider new safety problems associated with the hyped cancer meds.