19:24 , Jul 19, 2019 |  BC Extra  |  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...
23:07 , Apr 29, 2019 |  BC Extra  |  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...
03:03 , Jan 26, 2019 |  BioCentury  |  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...
13:51 , Nov 19, 2018 |  BioCentury  |  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...
16:41 , Sep 7, 2018 |  BC Week In Review  |  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...
18:15 , Aug 31, 2018 |  BC Extra  |  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...
16:43 , Jul 6, 2018 |  BC Week In Review  |  Clinical News

Neovacs planning Phase III for lupus therapy on mixed Phase IIb data

Neovacs S.A. (Euronext:ALNEV) plans to start Phase III testing of lupus candidate IFNalpha-Kinoid despite reporting mixed data from a Phase IIb trial in the indication. IFNalpha-Kinoid is an immunotherapy against interferon (IFN) alpha. The therapy...
15:05 , Jul 3, 2018 |  BC Extra  |  Clinical News

Neovacs planning Phase III for lupus therapy on mixed Phase IIb data

Neovacs S.A. (Euronext:ALNEV) plans to start Phase III testing of lupus candidate IFNalpha-Kinoid despite reporting mixed data from a Phase IIb trial in the indication on Tuesday. IFNalpha-Kinoid is an immunotherapy against interferon (IFN) alpha....
23:52 , Oct 6, 2017 |  BioCentury  |  Finance

Bargain shopping

With all companies valued over $1 billion increasing a median of at least 16.8% in 1H17, investors went bargain shopping in the $500-$999 million tier in 3Q17. The group outperformed all other market cap bands,...
23:50 , Jul 27, 2017 |  BC Week In Review  |  Clinical News

FDA approves GSK's subcutaneous Benlysta for SLE

FDA approved subcutaneous Benlysta belimumab from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat systemic lupus erythematosus (SLE). GSK said the human mAb against BLyS ( BAFF ; TNFSF13B) is the first subcutaneous, self-injectable therapy that FDA...