BioCentury | Jan 16, 2021
Product Development

Jan. 15 Quick Takes: Darzalex gains first FDA approval for form of amyloidosis; plus Thermo Fisher, Lilly, DBV, Dr. Reddy’s, Alexion, Taiho, Astellas-Actinium

FDA granted accelerated approval to Darzalex Faspro daratumumab/hyaluronidase-fihj from Johnson & Johnson (NYSE:JNJ) and Genmab A/S (CSE:GMAB; NASDAQ:GMAB) to treat newly diagnosed light-chain amyloidosis. It is the first and only therapy for the indication, according to Genmab,...
BioCentury | Jan 16, 2021
Finance

Greenwood-led fund to allow Dana-Farber to invest later in homegrown IP

Luba Greenwood, the Roche and Verily alum turned fund manager, told BioCentury that Dana-Farber’s new $10 million fund will give the institute a vehicle that allows it to participate in later rounds for its spinouts. The new...
BioCentury | Jan 15, 2021
Product Development

Delfi and Earli series A rounds show there’s room for new entrants in early cancer detection

The debut of two more venture-backed companies developing early cancer detection tests suggests there is still appetite for new approaches, even as bigger players consolidate via M&A and prepare for commercial launch. Delfi Diagnostics Inc....
BioCentury | Jan 15, 2021
Finance

A maturing mid-cap sector could keep funds flowing into biotech

While it’s too early to say whether 2020’s record year of fund-raising constitutes a “new normal,” there’s consensus among buysiders and bankers that a cheap money environment will continue in 2021 as...
BioCentury | Jan 15, 2021
Finance

Armed with newer data, $196M, NewAmsterdam hopes to resuscitate well-traveled CETP dyslipidemia program

A broad syndicate has funded NewAmsterdam with a $196 million (€160 million) series A round to assess whether a well-traveled CETP inhibitor can find a place in the treatment paradigm for dyslipidemia. Forbion, Morningside Ventures...
BioCentury | Jan 15, 2021
Product Development

Paige to accelerate development, adoption of digital cancer diagnostic with $100M series C

Paige’s $100 million series C suggests investor enthusiasm for cancer diagnostics extends beyond liquid biopsy and includes machine-learning tools for image-based pathology.  The New York-based company will use the funds to speed development of clinical applications,...
BioCentury | Jan 14, 2021
Regulation

After pushing FDA out of and back into COVID-19 LDT review, HHS turns to outsourcing

HHS is dealing with the fallout of its deregulatory push for COVID-19 lab tests by leaning on ex-FDA consultants for EUA reviews. The consulting and CDO firm NDA Partners, a subsidiary of The Planet Group...
BioCentury | Jan 14, 2021
Finance

With €127M series B, cancer vaccine developer IO Biotech raises second-largest European venture round in the past year

IO Biotech parlayed early clinical data into a €127 million ($154.8 million) series B financing led by HBM Healthcare Investments, which will support a Phase II trial of its leading cancer vaccines in combination with...
BioCentury | Jan 13, 2021
Emerging Company Profile

LifeMine taps fungal genomes for new drug candidates

Led by Rick Klausner and Gregory Verdine, LifeMine has found drug candidates with novel mechanisms using its data science platform for mining fungal genomes. The company now has an additional $50 million to move its first programs toward...
BioCentury | Jan 13, 2021
Finance

IPO filing reveals details of Sana’s deep pipeline, aggregation of next-generation gene and cell therapy technologies

With its IPO filing Wednesday, well-funded start-up Sana has lifted the lid on a suite of technologies it has aggregated since 2018, giving it a pipeline of 11 cell and gene therapies. Its first INDs...
Items per page:
1 - 10 of 15363
BioCentury | Jan 16, 2021
Product Development

Jan. 15 Quick Takes: Darzalex gains first FDA approval for form of amyloidosis; plus Thermo Fisher, Lilly, DBV, Dr. Reddy’s, Alexion, Taiho, Astellas-Actinium

FDA granted accelerated approval to Darzalex Faspro daratumumab/hyaluronidase-fihj from Johnson & Johnson (NYSE:JNJ) and Genmab A/S (CSE:GMAB; NASDAQ:GMAB) to treat newly diagnosed light-chain amyloidosis. It is the first and only therapy for the indication, according to Genmab,...
BioCentury | Jan 16, 2021
Finance

Greenwood-led fund to allow Dana-Farber to invest later in homegrown IP

Luba Greenwood, the Roche and Verily alum turned fund manager, told BioCentury that Dana-Farber’s new $10 million fund will give the institute a vehicle that allows it to participate in later rounds for its spinouts. The new...
BioCentury | Jan 15, 2021
Product Development

Delfi and Earli series A rounds show there’s room for new entrants in early cancer detection

The debut of two more venture-backed companies developing early cancer detection tests suggests there is still appetite for new approaches, even as bigger players consolidate via M&A and prepare for commercial launch. Delfi Diagnostics Inc....
BioCentury | Jan 15, 2021
Finance

A maturing mid-cap sector could keep funds flowing into biotech

While it’s too early to say whether 2020’s record year of fund-raising constitutes a “new normal,” there’s consensus among buysiders and bankers that a cheap money environment will continue in 2021 as...
BioCentury | Jan 15, 2021
Finance

Armed with newer data, $196M, NewAmsterdam hopes to resuscitate well-traveled CETP dyslipidemia program

A broad syndicate has funded NewAmsterdam with a $196 million (€160 million) series A round to assess whether a well-traveled CETP inhibitor can find a place in the treatment paradigm for dyslipidemia. Forbion, Morningside Ventures...
BioCentury | Jan 15, 2021
Product Development

Paige to accelerate development, adoption of digital cancer diagnostic with $100M series C

Paige’s $100 million series C suggests investor enthusiasm for cancer diagnostics extends beyond liquid biopsy and includes machine-learning tools for image-based pathology.  The New York-based company will use the funds to speed development of clinical applications,...
BioCentury | Jan 14, 2021
Regulation

After pushing FDA out of and back into COVID-19 LDT review, HHS turns to outsourcing

HHS is dealing with the fallout of its deregulatory push for COVID-19 lab tests by leaning on ex-FDA consultants for EUA reviews. The consulting and CDO firm NDA Partners, a subsidiary of The Planet Group...
BioCentury | Jan 14, 2021
Finance

With €127M series B, cancer vaccine developer IO Biotech raises second-largest European venture round in the past year

IO Biotech parlayed early clinical data into a €127 million ($154.8 million) series B financing led by HBM Healthcare Investments, which will support a Phase II trial of its leading cancer vaccines in combination with...
BioCentury | Jan 13, 2021
Emerging Company Profile

LifeMine taps fungal genomes for new drug candidates

Led by Rick Klausner and Gregory Verdine, LifeMine has found drug candidates with novel mechanisms using its data science platform for mining fungal genomes. The company now has an additional $50 million to move its first programs toward...
BioCentury | Jan 13, 2021
Finance

IPO filing reveals details of Sana’s deep pipeline, aggregation of next-generation gene and cell therapy technologies

With its IPO filing Wednesday, well-funded start-up Sana has lifted the lid on a suite of technologies it has aggregated since 2018, giving it a pipeline of 11 cell and gene therapies. Its first INDs...
Items per page:
1 - 10 of 15363