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RSS FeedPosted by Michael Wonder on 27 May 2020
FDA grants priority review of Nucala for patients with hypereosinophilic syndrome
27 May 2020 - An approval would give Nucala a third indication in an eosinophil driven disease. ...
Posted by Michael Wonder on 27 May 2020
Alnylam announces U.S. FDA has granted priority review of the lumasiran new drug application for the treatment of primary hyperoxaluria type 1
26 May 2020 - PDUFA date set for 3 December 2020. ...
Posted by Michael Wonder on 22 May 2020
Passage Bio receives rare paediatric disease designation for PBGM01 for patients with GM1 gangliosidosis
21 May 2020 - PBGM01 to enter the clinic in fourth quarter of 2020. ...
Posted by Michael Wonder on 19 May 2020
Eiger BioPharmaceuticals announces FDA acceptance of NDA for filing with priority review of Zokinvy (lonafarnib) for treatment of progeria and progeroid laminopathies
19 May 2020 - Eiger BioPharmaceuticals today announced that the U.S. FDA accepted the new drug application for accelerated review of ...
Posted by Michael Wonder on 18 May 2020
Seelos Therapeutics receives rare paediatric disease designation for SLS-005 (trehalose) in Sanfilippo syndrome
15 May 2020 - Seelos Therapeutics today announced it has been granted rare paediatric disease designation for SLS-005 in Sanfilippo ...
Posted by Michael Wonder on 14 May 2020
FDA grants priority review of sutimlimab, potential first approved treatment of haemolysis in adult patients with cold agglutinin disease
14 May 2020 - Sutimlimab targets C1-activated haemolysis in cold agglutinin disease. ...
Posted by Michael Wonder on 11 May 2020
CRISPR Therapeutics and Vertex Pharmaceuticals announce FDA regenerative medicine advanced therapy designation granted to CTX001 for the treatment of severe hemoglobinopathies
11 May 2020 - CTX001 has received orphan drug designation from the U.S. FDA for transfusion-dependent beta thalassemia and from the ...
Posted by Michael Wonder on 07 May 2020
FDA grants paediatric disease designation for Mateon's CA4P
5 May 2020 - Treatment of stage IIB–IV melanoma due to genetic mutations that disproportionately affect paediatric patients. ...
Posted by Michael Wonder on 06 May 2020
Immunicum receives regenerative medicine advanced therapy designation from FDA for ilixadencel in kidney cancer
6 May 2020 - Immunicum announced today that it has received regenerative medicine advanced therapy designation from the U.S. FDA for ...
Posted by Michael Wonder on 06 May 2020
Antabio receives FDA qualified infectious disease product designation for MEM-ANT3310, a novel broad-spectrum combination therapy targeting WHO’s priority pathogens
6 May 2020 - QIDP is granted to Antabio’s MEM-ANT3310 for major hospital indications including nosocomial pneumonia. ...
Posted by Michael Wonder on 05 May 2020
Acceleron receives PRIME Designation from EMA for sotatercept in pulmonary arterial hypertension
4 May 2020 - PRIME designation comes just three weeks after US FDA granted sotatercept breakthrough therapy designation. ...
Posted by Michael Wonder on 01 May 2020
U.S. FDA accepts for priority review Bristol Myers Squibb’s application for CC-486 for maintenance treatment of adult patients in remission with acute myeloid leukaemia
1 May 2020 - Application based on results from the Phase 3 QUAZAR-AML-001 study. ...
Posted by Michael Wonder on 22 Apr 2020
Novartis Kymriah receives FDA regenerative medicine advanced therapy designation in follicular lymphoma
22 April 2020 - US regulatory filing for Kymriah in relapsed/refractory follicular lymphoma anticipated in 2021. ...
Posted by Michael Wonder on 17 Apr 2020
FDA accepts for priority review biologics license application for REGN-EB3 to treat Ebola
16 April 2020 - REGN-EB3 developed via same rapid response platform currently being leveraged to develop novel COVID-19 antibody therapy. ...
Posted by Michael Wonder on 07 Apr 2020
Merck receives priority review from FDA for second application for Keytruda (pembrolizumab) based on biomarker, regardless of tumour type
7 April 2020 - Supplemental biologics license application accepted for Keytruda monotherapy in patients whose tumours are tumour mutational burden-high who ...