Ipsen

#Haematology #Ipsen #Mergers and acquisitions #Oncology

Ipsen acquires Kartos Therapeutics in $450m deal 

Biopharmaceutical company Ipsen has agreed a deal to acquire Kartos Therapeutics, expanding its haemato-oncology late-stage pipeline.  Ipsen will pay $450 million upfront as per the terms of the agreement, with Kartos Therapeutics shareholders eligible to receive payments of up to $1.3 million subject to regulatory approval milestones and sales-based milestones. … Read More

#Business & Investment #News

Human liver
#European Commission #Ipsen #Liver disease #Phase III trial #Rare disease

EU approves first new treatment for rare liver disease in a decade

The European Commission has conditionally approved Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA). The approval is limited to adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA. Read More

#News #Regulatory

#FDA #Ipsen #Phase III trial #Rare disease #Regulatory

FDA approves first treatment for rare connective tissue disorder

Ipsen’s Sohonos (palovarotene) has become the first drug approved for patients with fibrodysplasia ossificans progressiva (FOP) in the US, following the granting of a marketing authorisation by the Food and Drug Administration (FDA). The capsules are approved for reduction in the volume of new heterotopic ossification… Read More

#News #Regulatory

#CHMP #EMA #Ipsen #Marketing approval authorisation #Phase III trial #Regulatory

CHMP rejects rare bone disease treatment in EU

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended not to grant marketing authorisation for Ipsen’s investigational palovarotene as a treatment for fibrodysplasia ossificans progressiva (FOP).   The company says it will be requesting a re-examination of the CHMP opinion,… Read More

#News #Regulatory