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 | Apr 7, 2020
Product Development

April 6 Quick Takes: Second anemia approval for BMS, Acceleron therapy; plus EU approves trio of metabolic disease drugs, Dicerna-Alnylam and Axsome

Reblozyl gets second approval  FDA approved Reblozyl luspatercept-aamt from Bristol Myers Squibb Co. (NYSE:BMY) and Acceleron Pharma Inc. (NASDAQ:XLRN) to treat anemia in certain patients with myelodysplastic syndromes. It is the second indication for the...
BioCentury | Apr 3, 2020
Distillery Therapeutics

Depletion of the mitochondrial chaperone HspA9 for BRAF-mutant melanoma

DISEASE CATEGORY: Cancer INDICATION: Melanoma Reducing production of the mitochondrial chaperone HspA9 could treat BRAF-mutant melanoma. In melanoma patients, high tumor levels of HspA9 mRNA were associated with poor survival. In two human melanoma cell...
BioCentury | Apr 1, 2020
Deals

AAV tech pays off for Ultragenyx as Daiichi digs into gene therapy

Ultragenyx's AAV manufacturing deal with Daiichi Sankyo highlights the former's return on its investment in Dimension Therapeutics, and the latter's growing interest in gene therapy. The deal, announced Wednesday, gives Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) $125...
BioCentury | Feb 22, 2020
Product Development

Esperion enters crowded LDL-lowering market with FDA approval

FDA’s approval of Nexletol marks Esperion’s transition to a commercial-stage company. Esperion Therapeutics Inc. (NASDAQ:ESPR) plans to launch Nexletol bempedoic acid on March 30. The drug, which is orally administered once-daily, is approved as an...
BC Extra | 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 | Jan 1, 2020
Regulation

Fewer FDA approvals in 2019, but a basket of firsts

While the year held fewer approvals of new molecular entities than 2018, it was not short of major achievements. FDA greenlit several drugs with innovative modalities, against novel targets and for diseases that have long...
BC Extra | Dec 21, 2019
Company News

Efficacy data set trastuzumab ADC up for fast approval for third-line breast cancer

Less than two weeks after establishing a new threshold for efficacy in HER2+ breast cancer, Enhertu fam-trastuzumab deruxtecan-nxki has gained accelerated approval from FDA in the indication a mere two months after receiving Priority Review....
BC Extra | Dec 11, 2019
Clinical News

AstraZeneca, Daiichi’s trastuzumab ADC sets new efficacy bar in breast cancer

Trastuzumab deruxtecan from AstraZeneca and Daiichi Sankyo may have established a new threshold for efficacy in HER2+ breast cancer based on pivotal Phase II data. The data were better, in a sicker patient population, than...
BC Extra | Oct 21, 2019
Clinical News

Seattle Genetics at all-time high on strength of breast cancer readout

Seattle Genetics added more than $2 billion in market cap Monday after reporting pivotal survival data for breast cancer therapy tucatinib, a TKI targeting HER2 which is designed to have a favorable toxicity profile compared...
Items per page:
1 - 10 of 1468
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 | Apr 7, 2020
Product Development

April 6 Quick Takes: Second anemia approval for BMS, Acceleron therapy; plus EU approves trio of metabolic disease drugs, Dicerna-Alnylam and Axsome

Reblozyl gets second approval  FDA approved Reblozyl luspatercept-aamt from Bristol Myers Squibb Co. (NYSE:BMY) and Acceleron Pharma Inc. (NASDAQ:XLRN) to treat anemia in certain patients with myelodysplastic syndromes. It is the second indication for the...
BioCentury | Apr 3, 2020
Distillery Therapeutics

Depletion of the mitochondrial chaperone HspA9 for BRAF-mutant melanoma

DISEASE CATEGORY: Cancer INDICATION: Melanoma Reducing production of the mitochondrial chaperone HspA9 could treat BRAF-mutant melanoma. In melanoma patients, high tumor levels of HspA9 mRNA were associated with poor survival. In two human melanoma cell...
BioCentury | Apr 1, 2020
Deals

AAV tech pays off for Ultragenyx as Daiichi digs into gene therapy

Ultragenyx's AAV manufacturing deal with Daiichi Sankyo highlights the former's return on its investment in Dimension Therapeutics, and the latter's growing interest in gene therapy. The deal, announced Wednesday, gives Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) $125...
BioCentury | Feb 22, 2020
Product Development

Esperion enters crowded LDL-lowering market with FDA approval

FDA’s approval of Nexletol marks Esperion’s transition to a commercial-stage company. Esperion Therapeutics Inc. (NASDAQ:ESPR) plans to launch Nexletol bempedoic acid on March 30. The drug, which is orally administered once-daily, is approved as an...
BC Extra | 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 | Jan 1, 2020
Regulation

Fewer FDA approvals in 2019, but a basket of firsts

While the year held fewer approvals of new molecular entities than 2018, it was not short of major achievements. FDA greenlit several drugs with innovative modalities, against novel targets and for diseases that have long...
BC Extra | Dec 21, 2019
Company News

Efficacy data set trastuzumab ADC up for fast approval for third-line breast cancer

Less than two weeks after establishing a new threshold for efficacy in HER2+ breast cancer, Enhertu fam-trastuzumab deruxtecan-nxki has gained accelerated approval from FDA in the indication a mere two months after receiving Priority Review....
BC Extra | Dec 11, 2019
Clinical News

AstraZeneca, Daiichi’s trastuzumab ADC sets new efficacy bar in breast cancer

Trastuzumab deruxtecan from AstraZeneca and Daiichi Sankyo may have established a new threshold for efficacy in HER2+ breast cancer based on pivotal Phase II data. The data were better, in a sicker patient population, than...
BC Extra | Oct 21, 2019
Clinical News

Seattle Genetics at all-time high on strength of breast cancer readout

Seattle Genetics added more than $2 billion in market cap Monday after reporting pivotal survival data for breast cancer therapy tucatinib, a TKI targeting HER2 which is designed to have a favorable toxicity profile compared...
Items per page:
1 - 10 of 1468