BioCentury | Feb 14, 2020
Product Development

Feb. 13 Product Development Quick Takes: Priority Review for BMS, Seattle Genetics, Deciphera therapies; plus Roche, Ipsen, Merck, Eisai and Amgen-Pfizer

August decision dates for BMS, Seattle Genetics, Deciphera  A trio of cancer therapies have received Priority Review from FDA with August PDUFA dates. Bristol-Myers Squibb Co. (NYSE:BMY) said FDA accepted a BLA for lisocabtagene maraleucel...
BioCentury | Feb 4, 2020
Product Development

Feb. 3 Product Development Quick Takes: European Commission’s €10M coronavirus program; plus Seqirus, Seattle Genetics, Merck, Lilly, NIAID

EC outlines €10M coronavirus program  The European Commission said it will use €10 million from its Horizon 2020 program to fund research into prevention and treatment of 2019-nCoV acute respiratory disease. The funding is expected...
BC Extra | Jan 22, 2020
Company News

Jan. 21 Company Quick Takes: First BCMA-targeted therapy gets Priority Review from FDA; plus Roche-Seattle Genetics, AZ-Merck, Chi-Med

Priority Review for GSK's anti-BCMA therapy in MM  GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said FDA granted Priority Review to a BLA for belantamab mafodotin to treat fourth-line relapsed or refractory multiple myeloma in patients who have...
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...
BioCentury | Dec 27, 2019
Product Development

Two-year-old Xyphos gains exit as Astellas scoops up CAR T switch platform

After splitting from parent company AvidBiotics in 2017, Xyphos has taken a short path to reward the decision with a takeout by Astellas. The Japanese pharma will use the technology to build its immuno-oncology pipeline,...
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 18, 2019
Company News

Dec. 18 Company Quick Takes: FDA approves enfortumab vedotin; plus ODAC roundup, Illumina-PacBio, Benlysta, Ultragenyx, Syros-GBT, Xtandi

Enfortumab vedotin approved for urothelial cancer FDA granted accelerated approval to Padcev enfortumab vedotin-ejfv from Seattle Genetics Inc. (NASDAQ:SGEN) and Astellas Pharma Inc. (Tokyo:4503) to treat locally advanced or metastatic urothelial cancer in adults who...
BC Extra | Nov 8, 2019
Preclinical News

Nov. 7 Preclinical Quick Takes: NIH drafts policy requiring more data sharing; plus Unum, Mission-BioLegend, DCprime and more

NIH pitches policy for greater sharing of data  NIH has published a draft of the NIH Policy for Data Management and Sharing to promote wider sharing of data and results generated from NIH-funded grant work...
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...
BC Extra | Oct 8, 2019
Company News

Oct. 8 Company Quick Takes: Novartis’ anti-VEGF approved for AMD; plus Merck-4D, Acorda, Clinuvel and Puma

Novartis’ Eylea competitor approved  FDA approved Beovu brolucizumab-dbll from Novartis AG (NYSE:NVS; SIX:NOVN) to treat wet age-related macular degeneration. In the Phase III HAWK and HARRIER trials, the anti-VEGF single-chain antibody fragment led to vision...
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BioCentury | Feb 14, 2020
Product Development

Feb. 13 Product Development Quick Takes: Priority Review for BMS, Seattle Genetics, Deciphera therapies; plus Roche, Ipsen, Merck, Eisai and Amgen-Pfizer

August decision dates for BMS, Seattle Genetics, Deciphera  A trio of cancer therapies have received Priority Review from FDA with August PDUFA dates. Bristol-Myers Squibb Co. (NYSE:BMY) said FDA accepted a BLA for lisocabtagene maraleucel...
BioCentury | Feb 4, 2020
Product Development

Feb. 3 Product Development Quick Takes: European Commission’s €10M coronavirus program; plus Seqirus, Seattle Genetics, Merck, Lilly, NIAID

EC outlines €10M coronavirus program  The European Commission said it will use €10 million from its Horizon 2020 program to fund research into prevention and treatment of 2019-nCoV acute respiratory disease. The funding is expected...
BC Extra | Jan 22, 2020
Company News

Jan. 21 Company Quick Takes: First BCMA-targeted therapy gets Priority Review from FDA; plus Roche-Seattle Genetics, AZ-Merck, Chi-Med

Priority Review for GSK's anti-BCMA therapy in MM  GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said FDA granted Priority Review to a BLA for belantamab mafodotin to treat fourth-line relapsed or refractory multiple myeloma in patients who have...
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...
BioCentury | Dec 27, 2019
Product Development

Two-year-old Xyphos gains exit as Astellas scoops up CAR T switch platform

After splitting from parent company AvidBiotics in 2017, Xyphos has taken a short path to reward the decision with a takeout by Astellas. The Japanese pharma will use the technology to build its immuno-oncology pipeline,...
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 18, 2019
Company News

Dec. 18 Company Quick Takes: FDA approves enfortumab vedotin; plus ODAC roundup, Illumina-PacBio, Benlysta, Ultragenyx, Syros-GBT, Xtandi

Enfortumab vedotin approved for urothelial cancer FDA granted accelerated approval to Padcev enfortumab vedotin-ejfv from Seattle Genetics Inc. (NASDAQ:SGEN) and Astellas Pharma Inc. (Tokyo:4503) to treat locally advanced or metastatic urothelial cancer in adults who...
BC Extra | Nov 8, 2019
Preclinical News

Nov. 7 Preclinical Quick Takes: NIH drafts policy requiring more data sharing; plus Unum, Mission-BioLegend, DCprime and more

NIH pitches policy for greater sharing of data  NIH has published a draft of the NIH Policy for Data Management and Sharing to promote wider sharing of data and results generated from NIH-funded grant work...
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...
BC Extra | Oct 8, 2019
Company News

Oct. 8 Company Quick Takes: Novartis’ anti-VEGF approved for AMD; plus Merck-4D, Acorda, Clinuvel and Puma

Novartis’ Eylea competitor approved  FDA approved Beovu brolucizumab-dbll from Novartis AG (NYSE:NVS; SIX:NOVN) to treat wet age-related macular degeneration. In the Phase III HAWK and HARRIER trials, the anti-VEGF single-chain antibody fragment led to vision...
Items per page:
1 - 10 of 844