BioCentury | Nov 14, 2020
Regulation

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

...a major objection by the Committee for Advanced Therapies...
BioCentury | Aug 29, 2020
Deals

Data Bytes: Cryoport deals show continued interest in cell, gene therapy manufacturing and supply chain players

Cryoport’s acquisitions of MVE Biological Solutions and CRYOPDP are the latest in a string of takeovers focused on the support network that fuels cell and gene therapies. Cell and gene therapies are unique in that...
BioCentury | Jul 29, 2020
Politics, Policy & Law

Alliance for Regenerative Medicine sees advanced therapies as pilot for EU's regular use of real-world evidence

As the European Commisson hammers out how best to incorporate real world evidence into the future of medicines regulation and reimbursement, the Alliance for Regenerative Medicine is calling for the EU bloc to use cell...
BioCentury | Jun 27, 2020
Deals

Who’ll buy uniQure now?

UniQure’s out-licensing deal for its lead gene therapy program in hemophilia B may have disappointed investors, but that does not preclude the Dutch company from remaining an attractive takeout target. Investors immediately soured on Wednesday’s...
BioCentury | May 9, 2020
Deals

jCyte-Santen deal positions CIRM-funded stem cell therapy for pivotal studies, global access

Cash from an ex-U.S. licensing deal with Santen, plus years of grants from CIRM, position jCyte to bring its genetic blindness stem cell therapy into pivotal studies. Santen Pharmaceutical Co. Ltd. (Tokyo:4536) will receive exclusive...
BioCentury | Apr 10, 2020
Product Development

COVID-19 roundup: New immune targets to address pandemic; plus updates from CanSino, Arcturus, Fujifilm and more

...caused by COVID-19. The study evaluating the oral anti-inflammatory will be conducted by Yale University’s Advanced Therapies...
BioCentury | Apr 4, 2020
Management Tracks

CureVac names Stéphenne chairman; plus Desmond-Hellmann to Pfizer’s board, Reagan-Udall, Kyowa Kirin, Assembly, BioCryst and more

...of the boards of the American Society of Gene and Cell therapy, was president of Advanced Therapies...
BioCentury | Mar 28, 2020
Translation in Brief

17 FDA-approved drugs show activity against SARS-CoV-2; two groups seek COVID-19 patient-derived mAbs; plus NYU, Scholar Rock and LIfT-King's College

...iPS cell-derived antitumor neutrophils LIfT BioSciences Ltd. partnered with King's College London, via the London Advanced Therapies...
BioCentury | Mar 12, 2020
Regulation

As EMA shifts to virtual meetings, agency doesn’t expect impact on drug assessments, safety monitoring

...decision affects 20 events, including two CHMP meetings and two meetings of the Committee for Advanced Therapies...
BioCentury | Feb 5, 2020
Regulation

EMA’s plan to integrate real-world data across Europe

...make their way to market, RWD will only become more important, as many of these advanced therapies...
...chair of the committee for advanced therapies (CAT) at EMA, told BioCentury that since 2009, 14 advanced therapies...
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1 - 10 of 143
BioCentury | Nov 14, 2020
Regulation

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

...a major objection by the Committee for Advanced Therapies...
BioCentury | Aug 29, 2020
Deals

Data Bytes: Cryoport deals show continued interest in cell, gene therapy manufacturing and supply chain players

Cryoport’s acquisitions of MVE Biological Solutions and CRYOPDP are the latest in a string of takeovers focused on the support network that fuels cell and gene therapies. Cell and gene therapies are unique in that...
BioCentury | Jul 29, 2020
Politics, Policy & Law

Alliance for Regenerative Medicine sees advanced therapies as pilot for EU's regular use of real-world evidence

As the European Commisson hammers out how best to incorporate real world evidence into the future of medicines regulation and reimbursement, the Alliance for Regenerative Medicine is calling for the EU bloc to use cell...
BioCentury | Jun 27, 2020
Deals

Who’ll buy uniQure now?

UniQure’s out-licensing deal for its lead gene therapy program in hemophilia B may have disappointed investors, but that does not preclude the Dutch company from remaining an attractive takeout target. Investors immediately soured on Wednesday’s...
BioCentury | May 9, 2020
Deals

jCyte-Santen deal positions CIRM-funded stem cell therapy for pivotal studies, global access

Cash from an ex-U.S. licensing deal with Santen, plus years of grants from CIRM, position jCyte to bring its genetic blindness stem cell therapy into pivotal studies. Santen Pharmaceutical Co. Ltd. (Tokyo:4536) will receive exclusive...
BioCentury | Apr 10, 2020
Product Development

COVID-19 roundup: New immune targets to address pandemic; plus updates from CanSino, Arcturus, Fujifilm and more

...caused by COVID-19. The study evaluating the oral anti-inflammatory will be conducted by Yale University’s Advanced Therapies...
BioCentury | Apr 4, 2020
Management Tracks

CureVac names Stéphenne chairman; plus Desmond-Hellmann to Pfizer’s board, Reagan-Udall, Kyowa Kirin, Assembly, BioCryst and more

...of the boards of the American Society of Gene and Cell therapy, was president of Advanced Therapies...
BioCentury | Mar 28, 2020
Translation in Brief

17 FDA-approved drugs show activity against SARS-CoV-2; two groups seek COVID-19 patient-derived mAbs; plus NYU, Scholar Rock and LIfT-King's College

...iPS cell-derived antitumor neutrophils LIfT BioSciences Ltd. partnered with King's College London, via the London Advanced Therapies...
BioCentury | Mar 12, 2020
Regulation

As EMA shifts to virtual meetings, agency doesn’t expect impact on drug assessments, safety monitoring

...decision affects 20 events, including two CHMP meetings and two meetings of the Committee for Advanced Therapies...
BioCentury | Feb 5, 2020
Regulation

EMA’s plan to integrate real-world data across Europe

...make their way to market, RWD will only become more important, as many of these advanced therapies...
...chair of the committee for advanced therapies (CAT) at EMA, told BioCentury that since 2009, 14 advanced therapies...
Items per page:
1 - 10 of 143