BioCentury | Dec 31, 2020
Regulation

Dec. 30 Quick Takes: A first for Chi-Med; plus Orphazyme, BMS, FDA REMS, Pfizer, Astellas, Alkermes, Osmotica, Quanterix, Ampio and Novartis

...a partner.Delay for Orphazyme’s arimoclomolFDA extended the review period of the NDA for arimoclomol from Orphazyme...
...Niemann-Pick disease type C by three months. The new PDUFA date is June 17, 2021. Orphazyme...
BioCentury | Dec 12, 2020
Management Tracks

Lum & Dipp’s Biospring rounds out team; plus CHOP’s Smith-Whitley joins GBT and updates from Orphazyme, Kronos, Dewpoint, Enanta and more

...and objectives. He is succeeded as joint corporate secretary by Director of Investor Relations Jin’nan Wang.Orphazyme...
...NASDAQ:VRTX), where she was most recently VP, external innovation, business development. BC Staff Biospring Partners Global Blood Therapeutics Inc. Alphamab Oncology Orphazyme Adagene Kronos...
BioCentury | Sep 30, 2020
Product Development

Sept. 29 Quick Takes: Ironwood reduces headcount following Phase III miss; plus Sandoz, Catalyst, Myovant, Orphazyme, Synklino, WHO, BridgeBio, Kurma, Junshi, Arcutis, Genfit-LabCorp and GSK

...Relugolix is under Priority Review by FDA for the indication with a Dec. 20 PDUFA date. Orphazyme...
BioCentury | Sep 17, 2020
Product Development

Sept. 16 Quick Takes: AAT deficiency data lift Arrowhead; plus Metacrine’s IPO, Seer spinout and PDUFA dates for Niemann-Pick, burn therapies

...for Orphazyme’s Niemann-Pick therapyFDA accepted and granted Priority Review to an NDA for arimoclomal from Orphazyme...
...the small molecule inducer of Hsp70, which has a PDUFA date of March 17, 2021. Orphazyme...
...June 29, 2021.TARGETSHsp70 – heat shock protein 70 BC Staff NexoBrid (debrase gel dressing) arimoclomol (BRX-345, OR-01) ARO-AAT Vericel Corp. MediWound Ltd. Orphazyme...
BioCentury | Nov 27, 2019
Company News

Management tracks: Ultragenyx COO to step down next year; plus Agios, MiMedx, Iveric, Ardelyx, Novo Seeds, Axcella, NervGen

...served as CEO of F-star Biotechnology Ltd. from 2012-18; and Anders Hinsby, former CEO of Orphazyme...
BioCentury | Jul 15, 2019
Company News

Management tracks: GSK, Orphazyme, Kymera and more

...of the planned split of its consumer healthcare and innovative R&D businesses. Protein misfolding company Orphazyme...
...and neurosciences at AbbVie Inc. (NYSE:ABBV). Mary Romeo, Assistant Editor Cabaletta Bio Inc. GlaxoSmithKline plc Kymera Therapeutics LLC Navitor Pharmaceuticals Inc. Orphazyme...
BioCentury | Feb 1, 2019
Clinical News

Orphazyme finds path forward for Niemann-Pick therapy in subgroup data

...in 1H20 for the small molecule inducer of heat shock protein 70 (Hsp70). In September, Orphazyme...
...Clinical Global Impression of Improvement (CGI-I) from baseline to 12 months (p=1.00) vs. placebo (see "Orphazyme...
...pediatric disease designations in the U.S. for NPC, and Orphan Drug designation in the EU. Orphazyme...
BioCentury | Jan 30, 2019
Clinical News

Orphazyme finds path forward for Niemann-Pick therapy in subgroup data

...in 1H20 for the small molecule inducer of heat shock protein 70 (Hsp70). In September, Orphazyme...
...Clinical Global Impression of Improvement (CGI-I) from baseline to 12 months (p=1.00) vs. placebo (see "Orphazyme...
...designations in the U.S. for NPC, and Orphan Drug designation in the EU. Chris Lieu arimoclomol (BRX-345, OR-01) Orphazyme...
BioCentury | Jan 5, 2019
Finance

Ready to launch

...Onconova Therapeutics Inc. (NASDAQ:ONTX) / SymBio Pharmaceuticals Ltd. (Tokyo:4582) Rigosertib MDS Phase III data 2H19 Orphazyme...
BioCentury | Oct 19, 2018
Clinical News

Orphazyme seeking path forward for arimoclomol in NPC after Phase II/III miss

...patients to receive placebo or thrice-daily oral arimoclomol in addition to standard of care (SOC). Orphazyme...
...pediatric disease designations in the U.S. for NPC, and Orphan Drug designation in the EU. Orphazyme...
...Phase II/III data Milestone: Final Phase II/III (4Q18); extension study data (2Q19) Jaime De Leon arimoclomol (BRX-345, OR-01) Orphazyme...
Items per page:
1 - 10 of 33
BioCentury | Dec 31, 2020
Regulation

Dec. 30 Quick Takes: A first for Chi-Med; plus Orphazyme, BMS, FDA REMS, Pfizer, Astellas, Alkermes, Osmotica, Quanterix, Ampio and Novartis

...a partner.Delay for Orphazyme’s arimoclomolFDA extended the review period of the NDA for arimoclomol from Orphazyme...
...Niemann-Pick disease type C by three months. The new PDUFA date is June 17, 2021. Orphazyme...
BioCentury | Dec 12, 2020
Management Tracks

Lum & Dipp’s Biospring rounds out team; plus CHOP’s Smith-Whitley joins GBT and updates from Orphazyme, Kronos, Dewpoint, Enanta and more

...and objectives. He is succeeded as joint corporate secretary by Director of Investor Relations Jin’nan Wang.Orphazyme...
...NASDAQ:VRTX), where she was most recently VP, external innovation, business development. BC Staff Biospring Partners Global Blood Therapeutics Inc. Alphamab Oncology Orphazyme Adagene Kronos...
BioCentury | Sep 30, 2020
Product Development

Sept. 29 Quick Takes: Ironwood reduces headcount following Phase III miss; plus Sandoz, Catalyst, Myovant, Orphazyme, Synklino, WHO, BridgeBio, Kurma, Junshi, Arcutis, Genfit-LabCorp and GSK

...Relugolix is under Priority Review by FDA for the indication with a Dec. 20 PDUFA date. Orphazyme...
BioCentury | Sep 17, 2020
Product Development

Sept. 16 Quick Takes: AAT deficiency data lift Arrowhead; plus Metacrine’s IPO, Seer spinout and PDUFA dates for Niemann-Pick, burn therapies

...for Orphazyme’s Niemann-Pick therapyFDA accepted and granted Priority Review to an NDA for arimoclomal from Orphazyme...
...the small molecule inducer of Hsp70, which has a PDUFA date of March 17, 2021. Orphazyme...
...June 29, 2021.TARGETSHsp70 – heat shock protein 70 BC Staff NexoBrid (debrase gel dressing) arimoclomol (BRX-345, OR-01) ARO-AAT Vericel Corp. MediWound Ltd. Orphazyme...
BioCentury | Nov 27, 2019
Company News

Management tracks: Ultragenyx COO to step down next year; plus Agios, MiMedx, Iveric, Ardelyx, Novo Seeds, Axcella, NervGen

...served as CEO of F-star Biotechnology Ltd. from 2012-18; and Anders Hinsby, former CEO of Orphazyme...
BioCentury | Jul 15, 2019
Company News

Management tracks: GSK, Orphazyme, Kymera and more

...of the planned split of its consumer healthcare and innovative R&D businesses. Protein misfolding company Orphazyme...
...and neurosciences at AbbVie Inc. (NYSE:ABBV). Mary Romeo, Assistant Editor Cabaletta Bio Inc. GlaxoSmithKline plc Kymera Therapeutics LLC Navitor Pharmaceuticals Inc. Orphazyme...
BioCentury | Feb 1, 2019
Clinical News

Orphazyme finds path forward for Niemann-Pick therapy in subgroup data

...in 1H20 for the small molecule inducer of heat shock protein 70 (Hsp70). In September, Orphazyme...
...Clinical Global Impression of Improvement (CGI-I) from baseline to 12 months (p=1.00) vs. placebo (see "Orphazyme...
...pediatric disease designations in the U.S. for NPC, and Orphan Drug designation in the EU. Orphazyme...
BioCentury | Jan 30, 2019
Clinical News

Orphazyme finds path forward for Niemann-Pick therapy in subgroup data

...in 1H20 for the small molecule inducer of heat shock protein 70 (Hsp70). In September, Orphazyme...
...Clinical Global Impression of Improvement (CGI-I) from baseline to 12 months (p=1.00) vs. placebo (see "Orphazyme...
...designations in the U.S. for NPC, and Orphan Drug designation in the EU. Chris Lieu arimoclomol (BRX-345, OR-01) Orphazyme...
BioCentury | Jan 5, 2019
Finance

Ready to launch

...Onconova Therapeutics Inc. (NASDAQ:ONTX) / SymBio Pharmaceuticals Ltd. (Tokyo:4582) Rigosertib MDS Phase III data 2H19 Orphazyme...
BioCentury | Oct 19, 2018
Clinical News

Orphazyme seeking path forward for arimoclomol in NPC after Phase II/III miss

...patients to receive placebo or thrice-daily oral arimoclomol in addition to standard of care (SOC). Orphazyme...
...pediatric disease designations in the U.S. for NPC, and Orphan Drug designation in the EU. Orphazyme...
...Phase II/III data Milestone: Final Phase II/III (4Q18); extension study data (2Q19) Jaime De Leon arimoclomol (BRX-345, OR-01) Orphazyme...
Items per page:
1 - 10 of 33