CHMP with new Chair 13 meds recommended
The CHMP elected Harald Enzmann as its new Chair on Friday, and recommended thirteen medicines for approval, three thereof orphan medicines.
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European biotech companies enter IPO prep course
/in News/by Thomas GabrielczykEuropean 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
/in News/by Thomas GabrielczykNovo 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 […]
Pharming receives complete response letter from FDA
/in News/by Thomas GabrielczykThe 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
/in News/by Thomas GabrielczykCRISPR 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
/in News/by Thomas GabrielczykPositive 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 […]
Calcium does not contribute to heart failure
/in News/by Thomas GabrielczykSlowing 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
/in News/by Thomas GabrielczykEMBL 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
/in News/by Thomas GabrielczykOrphan 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 […]
PD1/PD-L1blockers trigger metastases
/in News/by Thomas GabrielczykDrug Developers dealing with PD1-PDL1 checkpoint inhibitors must consider new safety problems associated with the hyped cancer meds.