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).
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About Thomas Gabrielczyk
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Entries by Thomas Gabrielczyk
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.
EIB incentivises bioeconomy investments
The European Investment Bank (EIB) has issued its first Sustainability Awareness Bond worth €500m to support investments into water projects – health and nutrition to follow.
The future of agrochemistry
One of the worlds largest and most controversial mergers in the past few years was sealed in early June. German pharma and chemistry company Bayer has taken over US competitor Monsanto, forming the largest integrated provider of seeds, agrochemicals and digital farming solutions on the planet. The acquisition is part of a recent US$170bn deal binge that is already having a profound impact on the future of global agriculture.
New antibiotics on the block
Around 300 international AMR experts met at ESCMID-ASM drug development conference in Lisbon to discuss the latest progress in the field.