BioCentury | Feb 27, 2021
Product Development

Feb. 26 COVID Quick Takes: FDA wants more data from Merck; plus ‘clear efficacy’ for Regeneron and updates from GSK, Lilly, Novavax

Merck & Co. Inc. (NYSE:MRK) no longer expects to supply the U.S. with COVID-19 therapy MK-7110 by June 30 after FDA told the company additional data would be needed to support emergency use authorization. MK-7110,...
BioCentury | Feb 27, 2021
Regulation

Nod for Roche’s oral SMA drug among CHMP’s latest opinions: Data Byte

February’s recommendations by EMA’s CHMP included a nod in favor of Roche’s Evrysdi risdiplam, setting the drug up to become the first oral spinal muscular atrophy therapy in Europe.  CHMP recommended, under its accelerated assessment...
BioCentury | Feb 27, 2021
Distillery Therapeutics

Trastuzumab-RNA polymerase inhibitor conjugate for breast cancer with low HER2 expression

DISEASE CATEGORY: Cancer INDICATION: Breast cancer An antibody-drug conjugate comprising anti-HER2 antibody trastuzumab linked to POLR2A inhibitor α-amanitin could treat breast cancer with low HER2 expression and heterozygous loss of chromosome 17p. In a panel...
BioCentury | Feb 26, 2021
Emerging Company Profile

Immune-Onc building broad pipeline of myeloid checkpoint inhibitors

Launched in 2016, Immune-Onc is part of a growing class of immuno-oncology companies converting myeloid cells from immune-suppressing into tumor-suppressing agents. The Palo Alto-based company was co-founded by serial entrepreneur Guo-Liang Yu, an OrbiMed Advisors...
BioCentury | Feb 26, 2021
Distillery Therapeutics

Zelboraf-based PROTAC for melanoma, lung cancer expressing BRAF mutations

DISEASE CATEGORY: Cancer INDICATION: Melanoma; lung cancer A Yale University and Memorial Sloan Kettering Cancer Center team led by Arvinas Inc. (NASDAQ:ARVN) founder Craig Crews created a PROTAC based on Zelboraf vemurafenib that could treat BRAF...
BioCentury | Feb 26, 2021
Product Development

The dark of COVID-19 brings promise to Germany’s biotech scene

Apart from a few outliers, the biotech ecosystem in Germany has largely been devoid of life for over a decade. But COVID-19 has brought several more German stories into the limelight, and with them some...
BioCentury | Feb 26, 2021
Deals

Feb. 25 Quick Takes: AveXis execs, Deerfield launch Jaguar plus one; Sarepta DMD approval, Apollomics IPO plans and Sirion-Sanofi, an Oxford pair and DeuterOncology

Led by Sean Nolan as executive chairman and Joe Nolan as CEO, the former management team of AveXis partnered with Deerfield Management to launch Jaguar Gene Therapy LLC. Jaguar’s preclinical pipeline of AAV9-based gene therapies...
BioCentury | Feb 25, 2021
Finance

$135M series C buys Vividion flexibility to explore broad pipeline

After its $135 million series C raise Wednesday, Vividion has everything in place to take advantage of the surging market for IPOs: a broad syndicate of crossover investors, pharma partners in BMS and Roche, a CEO...
BioCentury | Feb 24, 2021
Deals

Feb. 23 Quick Takes: BGI raises $300M, plus a $230M C round for Clover, Day One, Waksal’s Graviton, Asalyxa

BGI Genomics Co. Ltd. (SZSE:300676) raised RMB2 billion ($309 million) through the sale of 13.8 million shares at RMB145 in a private placement. Huatai Securities Co. Ltd. purchased 8.3 million shares; also buying shares were China...
BioCentury | Feb 24, 2021
Product Development

Feb. 23 Quick Takes: Hold for bluebird; plus priority review for Pfizer’s TicoVac and updates from Taiho and NeuroRx

bluebird revealed late Wednesday in its 4Q20 earnings that FDA placed a clinical hold on its trials of LentiGlobin due to suspected unexpected serious adverse reactions in the Phase I/II HGB-206 trial. EMA also paused...
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1 - 10 of 65476
BioCentury | Feb 27, 2021
Product Development

Feb. 26 COVID Quick Takes: FDA wants more data from Merck; plus ‘clear efficacy’ for Regeneron and updates from GSK, Lilly, Novavax

Merck & Co. Inc. (NYSE:MRK) no longer expects to supply the U.S. with COVID-19 therapy MK-7110 by June 30 after FDA told the company additional data would be needed to support emergency use authorization. MK-7110,...
BioCentury | Feb 27, 2021
Regulation

Nod for Roche’s oral SMA drug among CHMP’s latest opinions: Data Byte

February’s recommendations by EMA’s CHMP included a nod in favor of Roche’s Evrysdi risdiplam, setting the drug up to become the first oral spinal muscular atrophy therapy in Europe.  CHMP recommended, under its accelerated assessment...
BioCentury | Feb 27, 2021
Distillery Therapeutics

Trastuzumab-RNA polymerase inhibitor conjugate for breast cancer with low HER2 expression

DISEASE CATEGORY: Cancer INDICATION: Breast cancer An antibody-drug conjugate comprising anti-HER2 antibody trastuzumab linked to POLR2A inhibitor α-amanitin could treat breast cancer with low HER2 expression and heterozygous loss of chromosome 17p. In a panel...
BioCentury | Feb 26, 2021
Emerging Company Profile

Immune-Onc building broad pipeline of myeloid checkpoint inhibitors

Launched in 2016, Immune-Onc is part of a growing class of immuno-oncology companies converting myeloid cells from immune-suppressing into tumor-suppressing agents. The Palo Alto-based company was co-founded by serial entrepreneur Guo-Liang Yu, an OrbiMed Advisors...
BioCentury | Feb 26, 2021
Distillery Therapeutics

Zelboraf-based PROTAC for melanoma, lung cancer expressing BRAF mutations

DISEASE CATEGORY: Cancer INDICATION: Melanoma; lung cancer A Yale University and Memorial Sloan Kettering Cancer Center team led by Arvinas Inc. (NASDAQ:ARVN) founder Craig Crews created a PROTAC based on Zelboraf vemurafenib that could treat BRAF...
BioCentury | Feb 26, 2021
Product Development

The dark of COVID-19 brings promise to Germany’s biotech scene

Apart from a few outliers, the biotech ecosystem in Germany has largely been devoid of life for over a decade. But COVID-19 has brought several more German stories into the limelight, and with them some...
BioCentury | Feb 26, 2021
Deals

Feb. 25 Quick Takes: AveXis execs, Deerfield launch Jaguar plus one; Sarepta DMD approval, Apollomics IPO plans and Sirion-Sanofi, an Oxford pair and DeuterOncology

Led by Sean Nolan as executive chairman and Joe Nolan as CEO, the former management team of AveXis partnered with Deerfield Management to launch Jaguar Gene Therapy LLC. Jaguar’s preclinical pipeline of AAV9-based gene therapies...
BioCentury | Feb 25, 2021
Finance

$135M series C buys Vividion flexibility to explore broad pipeline

After its $135 million series C raise Wednesday, Vividion has everything in place to take advantage of the surging market for IPOs: a broad syndicate of crossover investors, pharma partners in BMS and Roche, a CEO...
BioCentury | Feb 24, 2021
Deals

Feb. 23 Quick Takes: BGI raises $300M, plus a $230M C round for Clover, Day One, Waksal’s Graviton, Asalyxa

BGI Genomics Co. Ltd. (SZSE:300676) raised RMB2 billion ($309 million) through the sale of 13.8 million shares at RMB145 in a private placement. Huatai Securities Co. Ltd. purchased 8.3 million shares; also buying shares were China...
BioCentury | Feb 24, 2021
Product Development

Feb. 23 Quick Takes: Hold for bluebird; plus priority review for Pfizer’s TicoVac and updates from Taiho and NeuroRx

bluebird revealed late Wednesday in its 4Q20 earnings that FDA placed a clinical hold on its trials of LentiGlobin due to suspected unexpected serious adverse reactions in the Phase I/II HGB-206 trial. EMA also paused...
Items per page:
1 - 10 of 65476