BioCentury | Mar 24, 2021
Management Tracks

Abernethy to leave FDA in April; plus ICER, Maze, Nuvalent and Andera

...plc (LSE:GSK; NYSE:GSK); and Daniel Spiegelman, who most recently served as EVP and CFO at BioMarin Pharmaceutical Inc....
BioCentury | Jan 9, 2021
Finance

Targeted oncology is having a moment, again

...for hemophilia A therapy valoctocogene roxaparvovec from BioMarin...
BioCentury | Nov 18, 2020
Product Development

Nov. 17 Quick Takes: Phase III miss for BrainStorm’s ALS program; plus Novo, BioMarin-Deep Genomics, Lexicon, Seed-Lilly and RhoVac

...the approved dose without any increases in the frequency of known adverse events for the class.BioMarin...
...platform to identify oligonucleotide therapies in four undisclosed rare disease indiccations; financial terms are undisclosed. BioMarin...
BioCentury | Nov 14, 2020
Regulation

BioMarin withdraws MAA for hemophilia gene therapy following safety, durability concerns

...of opinions was an MAA withdrawal for BioMarin’s...
...the safety profile of Roctavian valoctocogene roxaparvovec from BioMarin Pharmaceutical Inc....
...Factor VIII to treat severe hemophilia A, BioMarin...
BioCentury | Nov 3, 2020
Regulation

BioMarin’s vosoritide clears regulatory hurdle as FDA sets goal date

...By Paul Bonanos, Associate Editor Although BioMarin’s NDA for its achondroplasia treatment doesn’t quite match up...
...date of Aug. 20, 2021.FDA’s action removes some uncertainty as to whether the dataset from BioMarin Pharmaceutical Inc....
...refusal-to-file letter was possible. The therapy received standard review to treat achondroplasia, a form of dwarfism.BioMarin...
BioCentury | Oct 8, 2020
Product Development

First patient dosed in Phase III hemophilia A trial could narrow gap between Pfizer/Sangamo and BioMarin

...One-year follow up for giroctocogene fitelparvovec will occur around the same time as BioMarin’s two-year follow-up...
...12 months, it could put the partners very close to the timing of key competitor BioMarin...
...after, Pfizer Inc. (NYSE:PFE) and Sangamo Therapeutics Inc. (NASDAQ:SGMO) could be neck and neck with BioMarin Pharmaceutical Inc....
BioCentury | Oct 6, 2020
Management Tracks

BioMarin, Sanofi tap new execs for early R&D positions

...promotes Nestle to head of research, CSO; Eggan joins BioMarin By Paul Bonanos, Associate Editor BioMarin...
...the French pharma has promoted from within to replace two executives who are leaving the company.BioMarin...
...Stanley Center for Psychiatric Research at the Broad Institute of MIT and Harvard.In recent years, BioMarin...
BioCentury | Oct 2, 2020
Finance

3Q20 Wrap: Biotech’s sideways quarter

...BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) the hardest hit down 38%, closing the quarter at a $13.8 billion valuation. BioMarin...
BioCentury | Aug 21, 2020
Regulation

Data Bytes: FDA approving new drugs at rapid clip in 2020

...Inc. (NASDAQ:GILD) and Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG); and Roctavian valoctocogene roxaparvovec, a hemophilia A gene therapy from BioMarin Pharmaceutical Inc....
BioCentury | Aug 20, 2020
Regulation

What FDA’s request for a new endpoint means for BioMarin’s hemophilia gene therapy

...Collecting two-year data will set BioMarin back at least 15 months, but it still has a...
...to market first By  Sandi Wong, Assistant Editor FDA has moved the goal post for BioMarin’s Roctavian...
...candidate could still be the first gene therapy to win approval for hemophilia A.Shares of BioMarin Pharmaceutical Inc....
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BioCentury | Mar 24, 2021
Management Tracks

Abernethy to leave FDA in April; plus ICER, Maze, Nuvalent and Andera

...plc (LSE:GSK; NYSE:GSK); and Daniel Spiegelman, who most recently served as EVP and CFO at BioMarin Pharmaceutical Inc....
BioCentury | Jan 9, 2021
Finance

Targeted oncology is having a moment, again

...for hemophilia A therapy valoctocogene roxaparvovec from BioMarin...
BioCentury | Nov 18, 2020
Product Development

Nov. 17 Quick Takes: Phase III miss for BrainStorm’s ALS program; plus Novo, BioMarin-Deep Genomics, Lexicon, Seed-Lilly and RhoVac

...the approved dose without any increases in the frequency of known adverse events for the class.BioMarin...
...platform to identify oligonucleotide therapies in four undisclosed rare disease indiccations; financial terms are undisclosed. BioMarin...
BioCentury | Nov 14, 2020
Regulation

BioMarin withdraws MAA for hemophilia gene therapy following safety, durability concerns

...of opinions was an MAA withdrawal for BioMarin’s...
...the safety profile of Roctavian valoctocogene roxaparvovec from BioMarin Pharmaceutical Inc....
...Factor VIII to treat severe hemophilia A, BioMarin...
BioCentury | Nov 3, 2020
Regulation

BioMarin’s vosoritide clears regulatory hurdle as FDA sets goal date

...By Paul Bonanos, Associate Editor Although BioMarin’s NDA for its achondroplasia treatment doesn’t quite match up...
...date of Aug. 20, 2021.FDA’s action removes some uncertainty as to whether the dataset from BioMarin Pharmaceutical Inc....
...refusal-to-file letter was possible. The therapy received standard review to treat achondroplasia, a form of dwarfism.BioMarin...
BioCentury | Oct 8, 2020
Product Development

First patient dosed in Phase III hemophilia A trial could narrow gap between Pfizer/Sangamo and BioMarin

...One-year follow up for giroctocogene fitelparvovec will occur around the same time as BioMarin’s two-year follow-up...
...12 months, it could put the partners very close to the timing of key competitor BioMarin...
...after, Pfizer Inc. (NYSE:PFE) and Sangamo Therapeutics Inc. (NASDAQ:SGMO) could be neck and neck with BioMarin Pharmaceutical Inc....
BioCentury | Oct 6, 2020
Management Tracks

BioMarin, Sanofi tap new execs for early R&D positions

...promotes Nestle to head of research, CSO; Eggan joins BioMarin By Paul Bonanos, Associate Editor BioMarin...
...the French pharma has promoted from within to replace two executives who are leaving the company.BioMarin...
...Stanley Center for Psychiatric Research at the Broad Institute of MIT and Harvard.In recent years, BioMarin...
BioCentury | Oct 2, 2020
Finance

3Q20 Wrap: Biotech’s sideways quarter

...BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) the hardest hit down 38%, closing the quarter at a $13.8 billion valuation. BioMarin...
BioCentury | Aug 21, 2020
Regulation

Data Bytes: FDA approving new drugs at rapid clip in 2020

...Inc. (NASDAQ:GILD) and Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG); and Roctavian valoctocogene roxaparvovec, a hemophilia A gene therapy from BioMarin Pharmaceutical Inc....
BioCentury | Aug 20, 2020
Regulation

What FDA’s request for a new endpoint means for BioMarin’s hemophilia gene therapy

...Collecting two-year data will set BioMarin back at least 15 months, but it still has a...
...to market first By  Sandi Wong, Assistant Editor FDA has moved the goal post for BioMarin’s Roctavian...
...candidate could still be the first gene therapy to win approval for hemophilia A.Shares of BioMarin Pharmaceutical Inc....
Items per page:
1 - 10 of 1077