BioCentury | Apr 8, 2021
Emerging Company Profile

Crossovers Fidelity, Surveyor invest early in ValenzaBio, backing $70M series A for rare autoimmune play

With a $70 million series A round led by Fidelity in a syndicate that included crossover Surveyor, start-up ValenzaBio is readying to take antibodies licensed from CRUK and Pierre Fabre into early clinical...
BioCentury | Mar 27, 2021
Product Development

A Vir’s-eye view of the path forward for its COVID mAbs

As Vir gears up to be third to market with a COVID-19 mAb therapy, the company thinks its pipeline could see broader use than authorized products, and believes the class will become a mainstay even as variants...
BioCentury | Mar 12, 2021
Politics, Policy & Law

PDUFA VII to feature $4M fee, focus on cell, gene therapies

FDA and biopharma industry representatives have agreed on most elements of the next Prescription Drug User Fee Act deal, including an increase in the application fee to about $4 million by 2027 from the current...
BioCentury | Mar 6, 2021
Finance

With $106M series C, Tenaya will bring AAV manufacturing in-house

With $106 million in new series C funding, Tenaya will internalize its AAV manufacturing capabilities and continue to advance its suite of gene therapy, cellular regeneration and precision medicine platforms for heart disease.  Tenaya Therapeutics...
BioCentury | Mar 4, 2021
Management Tracks

Amazon exec Lathia joins Flagship-backed Valo as chief product officer; plus AavantiBio, CatalYm, Corcept, Vincerx, OnCusp and more

Flagship-backed cloud computing-based drug discovery and development company Valo Health LLC named Nish Lathia chief product officer. The 18-year veteran of Amazon.com Inc. (NASDAQ:AMZN) held a variety of ecommerce and web services roles at that...
BioCentury | Mar 3, 2021
Product Development

Vir looking ahead to other COVID settings after value-destroying miss in hospitalized patients

Vir and GSK are looking ahead to an imminent readout for their mAb to treat high-risk COVID-19 outpatients after a DSMB recommended the closure of a study arm evaluating the therapy in hospitalized patients. Vir...
BioCentury | Feb 19, 2021
Product Development

First-time CEOs must stop doing what made them successful: Guest Commentary

First-time CEOs of biotechs must not fall in the trap of continuing to excel in the domain areas their career success has been built on. Effectively stepping up to the chief executive role requires getting...
BioCentury | Feb 16, 2021
Deals

Feb. 16 Quick Takes: Cytovia, Cellectis partner on TALEN-edited NK cells; plus Cend-Qilu, Iterion and Woodford

Cytovia Therapeutics Inc. and Cellectis S.A. (Euronext:ALCLS; NASDAQ:CLLS) began a strategic R&D collaboration to develop induced pluripotent stem cell-derived NK and CAR-NK cell therapies using TALEN gene editing. Cellectis will receive $15 million in Cytovia equity...
BioCentury | Feb 13, 2021
Finance

Qiming readies to kick off Chinese New Year with a first for Hong Kong exchange

After Qiming closed its sixth RMB fund in late January, Managing Partner Nisa Leung is looking ahead to her firm’s second public listing this year, one that she believes could clear a path for...
BioCentury | Feb 5, 2021
Product Development

Despite miss in biomarker study, PTC to discuss FDA approval pathway based on totality of data

PTC’s Translarna may have missed the endpoints in its Duchenne muscular dystrophy biomarker study, but the company believes clinical measures from the trial, data from its other studies and real-world evidence could support FDA approval....
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1 - 10 of 726
BioCentury | Apr 8, 2021
Emerging Company Profile

Crossovers Fidelity, Surveyor invest early in ValenzaBio, backing $70M series A for rare autoimmune play

With a $70 million series A round led by Fidelity in a syndicate that included crossover Surveyor, start-up ValenzaBio is readying to take antibodies licensed from CRUK and Pierre Fabre into early clinical...
BioCentury | Mar 27, 2021
Product Development

A Vir’s-eye view of the path forward for its COVID mAbs

As Vir gears up to be third to market with a COVID-19 mAb therapy, the company thinks its pipeline could see broader use than authorized products, and believes the class will become a mainstay even as variants...
BioCentury | Mar 12, 2021
Politics, Policy & Law

PDUFA VII to feature $4M fee, focus on cell, gene therapies

FDA and biopharma industry representatives have agreed on most elements of the next Prescription Drug User Fee Act deal, including an increase in the application fee to about $4 million by 2027 from the current...
BioCentury | Mar 6, 2021
Finance

With $106M series C, Tenaya will bring AAV manufacturing in-house

With $106 million in new series C funding, Tenaya will internalize its AAV manufacturing capabilities and continue to advance its suite of gene therapy, cellular regeneration and precision medicine platforms for heart disease.  Tenaya Therapeutics...
BioCentury | Mar 4, 2021
Management Tracks

Amazon exec Lathia joins Flagship-backed Valo as chief product officer; plus AavantiBio, CatalYm, Corcept, Vincerx, OnCusp and more

Flagship-backed cloud computing-based drug discovery and development company Valo Health LLC named Nish Lathia chief product officer. The 18-year veteran of Amazon.com Inc. (NASDAQ:AMZN) held a variety of ecommerce and web services roles at that...
BioCentury | Mar 3, 2021
Product Development

Vir looking ahead to other COVID settings after value-destroying miss in hospitalized patients

Vir and GSK are looking ahead to an imminent readout for their mAb to treat high-risk COVID-19 outpatients after a DSMB recommended the closure of a study arm evaluating the therapy in hospitalized patients. Vir...
BioCentury | Feb 19, 2021
Product Development

First-time CEOs must stop doing what made them successful: Guest Commentary

First-time CEOs of biotechs must not fall in the trap of continuing to excel in the domain areas their career success has been built on. Effectively stepping up to the chief executive role requires getting...
BioCentury | Feb 16, 2021
Deals

Feb. 16 Quick Takes: Cytovia, Cellectis partner on TALEN-edited NK cells; plus Cend-Qilu, Iterion and Woodford

Cytovia Therapeutics Inc. and Cellectis S.A. (Euronext:ALCLS; NASDAQ:CLLS) began a strategic R&D collaboration to develop induced pluripotent stem cell-derived NK and CAR-NK cell therapies using TALEN gene editing. Cellectis will receive $15 million in Cytovia equity...
BioCentury | Feb 13, 2021
Finance

Qiming readies to kick off Chinese New Year with a first for Hong Kong exchange

After Qiming closed its sixth RMB fund in late January, Managing Partner Nisa Leung is looking ahead to her firm’s second public listing this year, one that she believes could clear a path for...
BioCentury | Feb 5, 2021
Product Development

Despite miss in biomarker study, PTC to discuss FDA approval pathway based on totality of data

PTC’s Translarna may have missed the endpoints in its Duchenne muscular dystrophy biomarker study, but the company believes clinical measures from the trial, data from its other studies and real-world evidence could support FDA approval....
Items per page:
1 - 10 of 726