22:20 , May 31, 2019 |  BC Extra  |  Company News

May 31 Company Quick Takes: NMPA accepts two BeiGene applications, approves Hengrui's PD-1 inhibitor; and more

NMPA accepts applications for BeiGene's tislelizumab, Abraxane  China's National Medical Products Administration has accepted an sNDA from BeiGene Ltd. (NASDAQ:BGNE; HKSE:6160) for tislelizumab to treat previously treated, locally advanced or metastatic urothelial carcinoma. The anti-PD-1...
22:45 , May 29, 2019 |  BC Extra  |  Financial News

How cancer play Pi plans to deploy $19.7M series B

Existing investor Pontifax led a $19.7 million series B round for Pi, which is developing protein degradation modulators for drug-resistant multiple myeloma and solid tumor indications based on technology licensed from Johns Hopkins University. Founded...
19:33 , May 17, 2019 |  BC Extra  |  Company News

May 17 Company Quick Takes: A trio of FDA approvals; plus Ligand/Cumulus, Revlimid

Takeda's Gattex gets pediatric approval  FDA approved Gattex teduglutide from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) to include treatment of patients age one and older with short bowel syndrome who are dependent on parenteral support,...
18:03 , Mar 22, 2019 |  BC Week In Review  |  Clinical News

FDA places hold on Venclexta for multiple myeloma

FDA issued a safety warning after it placed a partial clinical hold on all trials evaluating Venclexta venetoclax to treat multiple myeloma after an interim analysis showed that the drug led to a higher proportion...
23:46 , Mar 21, 2019 |  BC Week In Review  |  Company News

NICE recommends Darzalex to treat MM, almost two years after European approval

The U.K.'s NICE recommended this month that Janssen Biotech's Darzalex daratumumab be available through the Cancer Drugs Fund as a second-line treatment for relapsed multiple myeloma in combination with bortezomib plus dexamethasone. The European Commission...
20:03 , Feb 11, 2019 |  BC Extra  |  Company News

Agios' Schenkein joins GV

Less than two weeks after stepping down as CEO of Agios Pharmaceuticals Inc. (NASDAQ:AGIO), David Schenkein has joined GV as general partner. Schenkein, who will remain executive chairman of Agios, will co-lead the firm’s life...
20:59 , Dec 14, 2018 |  BC Week In Review  |  Clinical News

Darzalex combo meets PFS endpoint in first-line MM

Genmab A/S (CSE:GEN; Pink:GMXAY) and Janssen Biotech Inc. said Darzalex daratumumab plus Revlimid lenalidomide and dexamethasone met the primary endpoint of improving progression-free survival (PFS) in the Phase III MAIA trial to treat newly diagnosed...
04:21 , Nov 30, 2018 |  BC Innovations  |  Targets & Mechanisms

Adhesion targets emerge at ASH 2018

The next wave of targets in blood cancers and hematology will come from adhesion molecules, innate immune cells and regulators of gene expression, according to BioCentury’s analysis of emerging targets at ASH 2018. BioCentury’s analysis...
15:43 , Sep 27, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Multiple myeloma (MM) Patient sample, cell culture and mouse studies suggest antagonizing AHR could help treat MM. In patients, high tumor levels of AHR correlated with poor survival. In multiple Velcade bortezomib-resistant and -sensitive...
22:58 , Sep 14, 2018 |  BioCentury  |  Regulation

Closing NICE’s Orphan gap

As the list of Orphan drugs rejected by NICE grows, industry and patient groups are pressuring the agency to make broader use of tools that currently apply only to selected ultra-Orphan therapies. These tools allow...