AMO Pharma receives FDA Fast Track Status
London-based orphan drug developer AMO Pharmas drug AMO-02 has been granted FDA fast track status as treatment for congenital myotonic dystrophy, a sub-indication muscular dystrophy.
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Entries by Thomas Gabrielczyk
Biocorp partners with Virbac
French drug delivery specialist Biocorp S.A. (Issoire) has signed an industrialisation contract with Virbac, one of the top-ten vet-med makers.
Janssen speeds up guselkumab approval process
Janssen speeds up US approval of psoriasis antibody guselkumab and targets further indications.
Abzenas partner True North Therapeutics subject of US$825m take-over
British Abzena plc has announced that True North Therapeutics (TNT) will be taken over by Bioverativ Inc. Bioverativ will further develop TNT’s complement factor C1-blocking antibody TNT009, developed using technology, which was licenced from Abzenawhich was licenced from Abzena.
RA: Sanofi/Regeneron IL-6R blocker FDA-approved
Following the EMAs recommendation for EU approval of sarilumab as second-line treatment for rheumatoid arthritis, French drug giant Sanofi and partner Regeneron have also been given the green light from the US FDA.
Safety event delays US market approval of romosozumab
Top-Line Phase 3 data of Amgens/UCBs osteoporosis antibody romosozumab in postmenopausal women suggest efficacy but uncover a new safety signal.
Vesalius Biocapital fund raises €65m
Luxembourg-based venture capital specialist Vesalius Biocapital has closed the first round of Biocapital III fund that aims to invest into later-stage European life sciences companies.
Merck presents new CRISPR genome editing method
German Merck KGaA has developed a new genome editing tool dubbed proxy-CRISPR providing access to previously inaccessible microenviroments of the genome by modification of chromatin modifications.
Astellas completes Ogeda takeover
Astellas Pharma Inc. has completed the acquisition of Ogeda SA (previously Euroscreen SA, Gosselies, Belgium).
Vifor Pharma acquires US$50m share in Akebia
Swiss Vifor Pharma has agreed to acquire shares of Cambridge-based distributor Adebia worth US$50m in order exclusivly distribute its hypoxia-inducible factor (HIF) stabiliser vadadustat to 40% of US dialysis clinics.