04:43 , Dec 15, 2018 |  BioCentury  |  Product Development

O’Day’s expansive task at Gilead

A fresh executive team and a track record of building deep portfolios could allow incoming Gilead Sciences Inc. chairman and CEO Daniel O’Day do what his predecessors couldn’t -- make Gilead a leader outside of...
00:06 , Dec 15, 2018 |  BC Extra  |  Financial News

Shanghai Henlius up for Hong Kong IPO

Biosimilars company Shanghai Henlius Biotech Inc. (Shanghai, China) proposed on Friday to list on the Hong Kong stock exchange. Shanghai Henlius' lead compound is HLX01, a biosimilar of cancer and autoimmune drug MabThera rituximab from...
23:39 , Dec 14, 2018 |  BC Extra  |  Company News

FDA approves Celltrion's Herceptin biosimilar

FDA approved a BLA for Herceptin biosimilar Herzuma trastuzumab-pkrb from Celltrion Inc. (KOSDAQ:068270) to treat HER2-positive breast cancer. In April, Celltrion received complete response letters from FDA for Herzuma and Truxima rituximab-abbs, its Rituxan biosimilar....
23:37 , Dec 14, 2018 |  BC Extra  |  Company News

Amgen pulls out of Advaxis immunotherapy deal

Advaxis Inc. (NASDAQ:ADXS) will continue to enroll patients in a Phase I trial of its ADXS-NEO program despite Amgen Inc. (NASDAQ:AMGN) pulling out of a 2016 deal to develop the immunotherapy. Advaxis shares slid 37%...
23:22 , Dec 14, 2018 |  BC Extra  |  Company News

CHMP backs Besremi for polycythemia vera, two Shionogi drugs

EMA's CHMP recommended a basket of approvals and label extensions on Friday, including Orphan Drug Besremi ropeginterferon alfa-2b to treat polycythemia vera and a pair of treatments from Shionogi & Co. Ltd. (Tokyo:4507). The agency...
21:17 , Dec 14, 2018 |  BC Week In Review  |  Company News

Veteran Roche cancer executive O'Day to lead Gilead

Daniel O’Day will inherit a pile of cash and a company that is looking beyond infectious disease to carve out its space in cancer and build on its newly acquired CAR T platform when he...
20:23 , Dec 10, 2018 |  BC Extra  |  Company News

Veteran Roche cancer executive O'Day to lead Gilead

Daniel O’Day will inherit a pile of cash and a company that is looking beyond infectious disease to carve out its space in cancer and build on its newly acquired CAR T platform when he...
02:33 , Dec 8, 2018 |  BioCentury  |  Product Development

Intermittent move beyond Blincyto

A swath of data at ASH shows that companies have been able to move beyond the 28-day continuous dosing of Amgen Inc.’s first-generation BiTE, Blincyto, to build next-generation antibodies with more convenient, intermittent dosing and...
17:51 , Dec 7, 2018 |  BC Week In Review  |  Clinical News

New BCMA-targeted therapies could help sicker patients

Oral abstracts at this year’s American Society of Hematology meeting describing next generation anti-BCMA CARs from Poseida Therapeutics Inc. and Fred Hutchinson Cancer Research Center and a bispecific antibody from Amgen Inc. (NASDAQ:AMGN) hint that...
18:09 , Dec 5, 2018 |  BC Innovations  |  Translation in Brief

Engaging with exosomes

A University of Southern California team has developed synthetic exosomes that express multiple multivalent antibodies, giving them a function like T cell bispecific antibodies, but potentially higher avidity. In a paper published in November in...