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 13, 2019
Clinical News

Three late-stage wins shift the clinical landscape in SLE

A trio of companies reported positive data from late-stage systemic lupus erythematosis trials, raising hopes that new treatments are on the horizon for an indication that has seen only one new therapy approved in the...
BC Extra | Sep 20, 2019
Company News

Xospata poised for EU approval under accelerated assessment

EMA's CHMP recommended approval of Xospata for acute myelogenous leukemia in its September roundup. Under accelerated assessment, the agency backed Xospata gilteritinib from Astellas Pharma Inc. (Tokyo:4503) as monotherapy for relapsed or refractory AML in...
BC Extra | Aug 29, 2019
Clinical News

New lupus endpoint key to Phase III success for AZ’s anifrolumab

AstraZeneca's positive data for anifrolumab is the first successful Phase III trial in lupus in about a decade. But a previous Phase III failure for the mAb on a different endpoint leaves the pharma unable...
BC Extra | Jul 19, 2019
Company News

July 19 Company Quick Takes: First biosimilars of Avastin, Herceptin launched; plus Gilenya, Celltrion-Nan Fung and Celgene

Amgen, Allergan launch pair of biosimilars  Amgen Inc. (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) launched Mvasi bevacizumab-awwb and Kanjinti trastuzumab-anns in the U.S.; they are the first biosimilars of Avastin bevacizumab and Herceptin trastuzumab available in...
BC Extra | Apr 29, 2019
Company News

April 29 Quick Takes: Takeda, Emendo, ViiV, Zynquista, Benlysta and more

Takeda considering value-based pricing in EU  Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) is mulling employing a value-based pricing model in Europe for Alofisel darvadstrocel, a stem cell therapy to treat complex perianal fistulas in patients...
BioCentury | Jan 26, 2019
Product Development

Target wide, test narrow in lupus

While last year’s spate of clinical misses in lupus leave the field still in search of optimal targets, the 2019 outlook isn’t all doom. Companies with shots on goal are using sharper endpoints and aiming...
BioCentury | Nov 19, 2018
Regulation

FDA to apply light touch to biopharma apps

Concerned that regulatory uncertainty is preventing biopharma companies from developing digital tools that could help patients manage their health, FDA plans to exempt a broad range of apps and other software from premarket review. In...
BC Week In Review | Sep 7, 2018
Clinical News

AZ's anifrolumab misses in Phase III for lupus

AstraZeneca plc (LSE:AZN; NYSE:AZN) and its MedImmune LLC unit said anifrolumab (formerly MEDI-546) missed the primary endpoint in the Phase III TULIP 1 trial to treat systemic lupus erythematosus (SLE). Compared with placebo, anifrolumab failed...
BC Extra | Aug 31, 2018
Clinical News

AZ's anifrolumab misses in Phase III for lupus

AstraZeneca plc (LSE:AZN; NYSE:AZN) and its MedImmune LLC unit said anifrolumab (formerly MEDI-546) missed the primary endpoint in the Phase III TULIP 1 trial to treat systemic lupus erythematosus (SLE). Compared with placebo, anifrolumab failed...
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