BioCentury | May 6, 2020
Politics, Policy & Law

Bright shines harsh light on America’s COVID-19 preparedness, FDA’s independence

This story was updated to reflect additional comments from FDA that were provided after publication of the initial version. Cronyism has crippled America’s pandemic response, enriching undeserving entrepreneurs and politically potent consultants who siphoned funds...
BioCentury | Feb 13, 2019
Financial News

Arch-backed HiberCell launches with over $60M to target dormant cancer cells

...targeting dormant cancer cells. Cancer recurrence is driven by dormant disseminated tumor cells (DTCs) that lodge...
BioCentury | Feb 7, 2019
Financial News

Arch-backed HiberCell launches with over $60M to target dormant cancer cells

...targeting dormant cancer cells. Cancer recurrence is driven by dormant disseminated tumor cells (DTCs) that lodge...
BioCentury | Oct 5, 2018
Company News

GenScript denies data fraud claims, engages legal counsel

GenScript Biotech Corp. (HKSE:1548) recovered about HK$2.5 billion ($319.3 million) in market cap Sept. 28 after denying all allegations published in a report by short seller Flaming Research. The biotech lost about HK$8 billion ($1...
BioCentury | Aug 4, 2018
Strategy

Addressing sexual harassment claims at the board level

In today’s environment, no industry is immune from claims of workplace harassment. Allegations can not only tarnish a company’s -- and a board’s -- reputation, and impair shareholder value, but imperil the existence of a...
BioCentury | Oct 20, 2017
Clinical News

Spark gene therapy wins unanimous FDA panel vote

On Oct. 12, FDA's Cellular, Tissue and Gene Therapy Advisory Committee voted 16-0 that the benefit-risk profile for Luxturna voretigene neparvovec from Spark Therapeutics Inc. (NASDAQ:ONCE) supports the gene therapy's approval to treat biallelic retinal...
BioCentury | Oct 20, 2017
Regulation

Patients in focus

Just as FDA was wrapping up the inaugural meeting of its Patient Engagement Advisory Committee, another agency panel unanimously endorsed a gene therapy for a rare vision disorder based in large part on the testimony...
BioCentury | Oct 12, 2017
Politics & Policy

FDA patient panel offers ideas to improve trial participation

Panelists on FDA's Patient Engagement Advisory Committee (PEAC) concluded the group's inaugural meeting with recommendations for improving recruitment, retention and results communication in clinical trials of medical devices. The panel did not vote on any...
BioCentury | Oct 12, 2017
Company News

Spark gene therapy wins unanimous FDA panel vote

FDA's Cellular, Tissue and Gene Therapy Advisory Committee voted 16-0 that the benefit-risk profile for Luxturna voretigene neparvovec from Spark Therapeutics Inc. (NASDAQ:ONCE) supports the gene therapy's approval to treat biallelic retinal pigment epithelium-specific protein...
BioCentury | Sep 2, 2017
Strategy

Pathfinding for access

A pact with the Centers for Medicare & Medicaid Services for Novartis AG ’s CAR T therapy demonstrates leadership in new value-based drug pricing models. Kymriah tisagenlecleucel represents a milestone for three reasons. Its approval...
Items per page:
1 - 10 of 61
BioCentury | May 6, 2020
Politics, Policy & Law

Bright shines harsh light on America’s COVID-19 preparedness, FDA’s independence

This story was updated to reflect additional comments from FDA that were provided after publication of the initial version. Cronyism has crippled America’s pandemic response, enriching undeserving entrepreneurs and politically potent consultants who siphoned funds...
BioCentury | Feb 13, 2019
Financial News

Arch-backed HiberCell launches with over $60M to target dormant cancer cells

...targeting dormant cancer cells. Cancer recurrence is driven by dormant disseminated tumor cells (DTCs) that lodge...
BioCentury | Feb 7, 2019
Financial News

Arch-backed HiberCell launches with over $60M to target dormant cancer cells

...targeting dormant cancer cells. Cancer recurrence is driven by dormant disseminated tumor cells (DTCs) that lodge...
BioCentury | Oct 5, 2018
Company News

GenScript denies data fraud claims, engages legal counsel

GenScript Biotech Corp. (HKSE:1548) recovered about HK$2.5 billion ($319.3 million) in market cap Sept. 28 after denying all allegations published in a report by short seller Flaming Research. The biotech lost about HK$8 billion ($1...
BioCentury | Aug 4, 2018
Strategy

Addressing sexual harassment claims at the board level

In today’s environment, no industry is immune from claims of workplace harassment. Allegations can not only tarnish a company’s -- and a board’s -- reputation, and impair shareholder value, but imperil the existence of a...
BioCentury | Oct 20, 2017
Clinical News

Spark gene therapy wins unanimous FDA panel vote

On Oct. 12, FDA's Cellular, Tissue and Gene Therapy Advisory Committee voted 16-0 that the benefit-risk profile for Luxturna voretigene neparvovec from Spark Therapeutics Inc. (NASDAQ:ONCE) supports the gene therapy's approval to treat biallelic retinal...
BioCentury | Oct 20, 2017
Regulation

Patients in focus

Just as FDA was wrapping up the inaugural meeting of its Patient Engagement Advisory Committee, another agency panel unanimously endorsed a gene therapy for a rare vision disorder based in large part on the testimony...
BioCentury | Oct 12, 2017
Politics & Policy

FDA patient panel offers ideas to improve trial participation

Panelists on FDA's Patient Engagement Advisory Committee (PEAC) concluded the group's inaugural meeting with recommendations for improving recruitment, retention and results communication in clinical trials of medical devices. The panel did not vote on any...
BioCentury | Oct 12, 2017
Company News

Spark gene therapy wins unanimous FDA panel vote

FDA's Cellular, Tissue and Gene Therapy Advisory Committee voted 16-0 that the benefit-risk profile for Luxturna voretigene neparvovec from Spark Therapeutics Inc. (NASDAQ:ONCE) supports the gene therapy's approval to treat biallelic retinal pigment epithelium-specific protein...
BioCentury | Sep 2, 2017
Strategy

Pathfinding for access

A pact with the Centers for Medicare & Medicaid Services for Novartis AG ’s CAR T therapy demonstrates leadership in new value-based drug pricing models. Kymriah tisagenlecleucel represents a milestone for three reasons. Its approval...
Items per page:
1 - 10 of 61