16:50 , Oct 18, 2018 |  BC Extra  |  Company News

Flurry of news highlights latest in switch-controlled gene therapy

A series of company announcements signal advances in switch-controlled gene therapy. uniQure N.V. (NASDAQ:QURE) and partner Synpromics Ltd. (Edinburgh, U.K.) announced preclinical data on Thursday on a liver-directed gene therapy system at the European Society of...
23:16 , Oct 17, 2018 |  BC Extra  |  Company News

Express Scripts adds Aimovig, Emgality to new value-based migraine program; excludes Ajovy

Express Scripts Holding Co. (NASDAQ:ESRX) will include two of three FDA approved migraine prevention drugs in its value-based program for migraine, which it unveiled Wednesday. The PBM gave the nod to Aimovig erenumab-aooe from Amgen...
23:10 , Oct 17, 2018 |  BC Extra  |  Company News

Management tracks: Ziopharm, Merck

Immunotherapy company Ziopharm Oncology Inc. (NASDAQ:ZIOP) said CMO and EVP of R&D Francois Lebel will step down, effective Oct. 26. Merck & Co. Inc. (NYSE:MRK) hired Jim Scholefield as chief information and digital officer. He is...
23:48 , Oct 15, 2018 |  BC Extra  |  Company News

Management tracks: Rhythm, Redpin

Rhythm Pharmaceuticals Inc. (NASDAQ:RYTM) hired Murray Stewart as CMO of the metabolic disorder company. Stewart was CMO of GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) until 2017 when he became head of R&D at Novelion Therapeutics Inc. (NASDAQ:NVLN)....
18:17 , Oct 12, 2018 |  BC Week In Review  |  Clinical News

Clinical holds for Affimed's T cell bispecific following patient death

Affimed N.V. (NASDAQ:AFMD) fell $1.13 (24%) to $3.50 Oct. 9 after it placed a clinical hold on two studies of blood cancer candidate AFM11 following three treatment-related serious adverse events, including a patient death. The...
17:30 , Oct 12, 2018 |  BC Week In Review  |  Clinical News

FDA panel votes in favor of Celltrion's rituximab biosimilar

FDA's Oncologic Drugs Advisory Committee voted 16-0 on Oct. 10 that a resubmitted BLA from Celltrion Inc. (KRX:068270) supports approval of CT-P10, its biosimilar of Rituxan/MabThera rituximab. The panel backed the biosimilar's approval as a monotherapy...
22:55 , Oct 11, 2018 |  BC Week In Review  |  Financial News

JHL raises financing at $750M valuation

Biosimilars company JHL Biotech Inc. (Zhubei, Taiwan) raised an undisclosed amount in a private financing at a valuation of $750 million. Participating in the financing were Sanofi (Euronext:SAN; NYSE:SNY) and other undisclosed investors, according to...
22:09 , Oct 10, 2018 |  BC Extra  |  Company News

FDA panel votes in favor of Celltrion's rituximab biosimilar

FDA's Oncologic Drugs Advisory Committee voted 16-0 Wednesday that a resubmitted BLA from Celltrion Inc. (KRX:068270) supports approval of CT-P10, its biosimilar of Rituxan/MabThera rituximab. The panel backed the biosimilar's approval as a monotherapy to...
21:44 , Oct 10, 2018 |  BC Extra  |  Politics & Policy

China adds insurance coverage for 17 cancer therapies

China's National Medical Insurance Administration added 17 cancer drugs to the National Reimbursement Drug List (NRDL) for coverage by the country's medical insurance program. The prices will go into effect by the end of October and...
20:30 , Oct 9, 2018 |  BC Extra  |  Clinical News

Affimed sinks after placing clinical hold on bispecific T cell engager

Affimed N.V. (NASDAQ:AFMD) fell $1.13 (24%) to $3.50 Tuesday after it placed a clinical hold on two studies of blood cancer candidate AFM11 following three treatment-related serious adverse events, including a patient death. The product...