BioCentury | Jan 22, 2021
Regulation

CAR T Yescarta among new approvals by Japanese regulator

Yescarta became the second approved CAR T therapy in Japan, joining a basket of new approvals by the country’s Ministry of Health, Labour and Welfare. The therapy, developed by Gilead Sciences Inc. (NASDAQ:GILD) and partnered...
BioCentury | Jul 23, 2020
Deals

July 22 Quick Takes: BioNTech raises $512M; plus Vesigen, Quantro, Cullinan, TransThera, JW-Syracuse, AnHeart-NewG

BioNTech prices upsized financing BioNTech SE (NASDAQ:BNTX) raised $511.5 million in an upsized offering through the sale of 5.5 million ADSs at $93 per ADS. The deal, which had been slated for 5 million ADSs,...
BioCentury | Jul 2, 2020
Emerging Company Profile

Bolt’s myeloid twist on ADCs charged up with $93.5M series C

Bolt’s $93.5 million series C round will enable the Stanford spinout to clinically test whether its myeloid-activating antibody conjugate can provide durable treatment to a broad swath of HER2-positive solid tumor patients. Led by Sofinnova...
BioCentury | Jun 26, 2020
Regulation

Data Bytes: CHMP’s June opinions

A recommendation by EMA’s CHMP suggests remdesivir from Gilead Sciences Inc. (NASDAQ:GILD) could soon gain a speedy conditional approval to treat COVID-19. The committee announced the decision this week along with a basket of other...
BioCentury | May 30, 2020
Product Development

ASCO data bring new markets within reach for two AstraZeneca therapies

AstraZeneca stole the show at ASCO on Friday with data that should help propel its top-grossing cancer drug and one of its newest market entrants into broadly expanded patient populations, as long as physicians adopt...
BioCentury | Jan 28, 2020
Company News

Jan. 27 Company Quick Takes: Enhertu meets in pivotal gastric cancer study; plus Biocon-Mylan, CMS, Lilly-Boehringer, Ningbo-Genentech

Japan submission on horizon for AZ, Daiichi’s ADC Daiichi Sankyo Co. Ltd. (Tokyo:4568) plans to seek approval of Enhertu for gastric cancer starting in Japan after the anti-HER2 antibody-drug conjugate met the primary and a...
BioCentury | Oct 19, 2019
Company News

Oct. 18 Company Quick Takes: AZ-Daiichi, Sanofi, Merck, Lilly and AFTD-Target ALS

Priority Review for breast cancer ADC from Daiichi, AZ AstraZeneca plc (LSE:AZN; NYSE:AZN) and Daiichi Sankyo Co. Ltd. (Tokyo:4568) said FDA accepted and granted Priority Review to a BLA for trastuzumab deruxtecan to treat HER2-positive...
BioCentury | Aug 2, 2019
Company News

Aug. 2 Company Quick Takes: Daiichi's cancer drug gets U.S. approval, plus BioMarin, Acorda, Stemline and more

FDA approves Daiichi's pexidartinib FDA approved Turalio pexidartinib from Daiichi Sankyo Co. Ltd. (Tokyo:4568) to treat tenosynovial giant cell tumor. A Daiichi spokesperson told BioCentury the drug has been launched at a wholesale acquisition cost...
BioCentury | Jun 21, 2019
Company News

June 21 Company Quick Takes: FDA rejects Daiichi's AML candidate; plus Sanofi, Novartis and more

Complete response letter for Daiichi's quizartinib Daiichi Sankyo Co. Ltd. (Tokyo:4568) said FDA issued a complete response letter for quizartinib, its candidate to treat relapsed/refractory FLT3-ITD-positive acute myelogenous leukemia (AML). In May, an FDA advisory...
BioCentury | May 10, 2019
Company News

May 10 Company Quick Takes: Red flags for Daiichi ahead of ODAC; plus JHL/Genentech, J&J, Gilead

FDA reviewers raise concerns about Daiichi’s quizartinib, pexidartinib Despite both pexidartinib and quizartinib meeting the primary endpoints in their pivotal trials, FDA reviewers raised concerns about each agent from Daiichi Sankyo Co. Ltd. (Tokyo:4568) in...
Items per page:
1 - 10 of 82
BioCentury | Jan 22, 2021
Regulation

CAR T Yescarta among new approvals by Japanese regulator

Yescarta became the second approved CAR T therapy in Japan, joining a basket of new approvals by the country’s Ministry of Health, Labour and Welfare. The therapy, developed by Gilead Sciences Inc. (NASDAQ:GILD) and partnered...
BioCentury | Jul 23, 2020
Deals

July 22 Quick Takes: BioNTech raises $512M; plus Vesigen, Quantro, Cullinan, TransThera, JW-Syracuse, AnHeart-NewG

BioNTech prices upsized financing BioNTech SE (NASDAQ:BNTX) raised $511.5 million in an upsized offering through the sale of 5.5 million ADSs at $93 per ADS. The deal, which had been slated for 5 million ADSs,...
BioCentury | Jul 2, 2020
Emerging Company Profile

Bolt’s myeloid twist on ADCs charged up with $93.5M series C

Bolt’s $93.5 million series C round will enable the Stanford spinout to clinically test whether its myeloid-activating antibody conjugate can provide durable treatment to a broad swath of HER2-positive solid tumor patients. Led by Sofinnova...
BioCentury | Jun 26, 2020
Regulation

Data Bytes: CHMP’s June opinions

A recommendation by EMA’s CHMP suggests remdesivir from Gilead Sciences Inc. (NASDAQ:GILD) could soon gain a speedy conditional approval to treat COVID-19. The committee announced the decision this week along with a basket of other...
BioCentury | May 30, 2020
Product Development

ASCO data bring new markets within reach for two AstraZeneca therapies

AstraZeneca stole the show at ASCO on Friday with data that should help propel its top-grossing cancer drug and one of its newest market entrants into broadly expanded patient populations, as long as physicians adopt...
BioCentury | Jan 28, 2020
Company News

Jan. 27 Company Quick Takes: Enhertu meets in pivotal gastric cancer study; plus Biocon-Mylan, CMS, Lilly-Boehringer, Ningbo-Genentech

Japan submission on horizon for AZ, Daiichi’s ADC Daiichi Sankyo Co. Ltd. (Tokyo:4568) plans to seek approval of Enhertu for gastric cancer starting in Japan after the anti-HER2 antibody-drug conjugate met the primary and a...
BioCentury | Oct 19, 2019
Company News

Oct. 18 Company Quick Takes: AZ-Daiichi, Sanofi, Merck, Lilly and AFTD-Target ALS

Priority Review for breast cancer ADC from Daiichi, AZ AstraZeneca plc (LSE:AZN; NYSE:AZN) and Daiichi Sankyo Co. Ltd. (Tokyo:4568) said FDA accepted and granted Priority Review to a BLA for trastuzumab deruxtecan to treat HER2-positive...
BioCentury | Aug 2, 2019
Company News

Aug. 2 Company Quick Takes: Daiichi's cancer drug gets U.S. approval, plus BioMarin, Acorda, Stemline and more

FDA approves Daiichi's pexidartinib FDA approved Turalio pexidartinib from Daiichi Sankyo Co. Ltd. (Tokyo:4568) to treat tenosynovial giant cell tumor. A Daiichi spokesperson told BioCentury the drug has been launched at a wholesale acquisition cost...
BioCentury | Jun 21, 2019
Company News

June 21 Company Quick Takes: FDA rejects Daiichi's AML candidate; plus Sanofi, Novartis and more

Complete response letter for Daiichi's quizartinib Daiichi Sankyo Co. Ltd. (Tokyo:4568) said FDA issued a complete response letter for quizartinib, its candidate to treat relapsed/refractory FLT3-ITD-positive acute myelogenous leukemia (AML). In May, an FDA advisory...
BioCentury | May 10, 2019
Company News

May 10 Company Quick Takes: Red flags for Daiichi ahead of ODAC; plus JHL/Genentech, J&J, Gilead

FDA reviewers raise concerns about Daiichi’s quizartinib, pexidartinib Despite both pexidartinib and quizartinib meeting the primary endpoints in their pivotal trials, FDA reviewers raised concerns about each agent from Daiichi Sankyo Co. Ltd. (Tokyo:4568) in...
Items per page:
1 - 10 of 82