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...
23:41 , Sep 12, 2018 |  BC Extra  |  Politics & Policy

China biopharma stocks fall after centralized tendering talks

Stocks of Chinese biopharma companies slid on Wednesday, possibly in response to a meeting Tuesday of China's National Medical Insurance Bureau on the centralized procurement of generics. Under centralized procurement, a single generic manufacturer would...
17:59 , Aug 3, 2018 |  BC Week In Review  |  Company News

China Medical gains Chinese product rights in trio of deals

China Medical System Holdings Ltd. (HKSE:867) announced a series of deals in July under which it gained rights to several products in China, including Hong Kong, Macao and Taiwan. China Medical obtained exclusive rights from Venus...
17:38 , Jul 17, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Multiple myeloma (MM) Patient sample and mouse studies suggest inhibiting NEK2 could help treat Velcade bortezomib-resistant MM. In MM patients, high levels of NEK2 in bone marrow plasma cells were associated with poor overall and...
19:58 , Jul 13, 2018 |  BC Week In Review  |  Company News

Shanghai Junshi licenses anti-PD-1 mAb to CSPC

Shanghai Junshi Biosciences Co. Ltd. (Shanghai, China) granted CSPC Pharmaceutical Group Ltd. (HKSE:1093) exclusive rights in China, including Hong Kong and Macau, and Taiwan to develop and commercialize an undisclosed anti-PD-1 mAb in combination with...
19:56 , Jul 13, 2018 |  BC Week In Review  |  Clinical News

Celgene reports detailed PFS data for Pomalyst triple combo in Phase III for MM

Celgene Corp. (NASDAQ:CELG) reported additional data from the Phase III OPTIMISMM trial in 559 patients with relapsed or refractory multiple myeloma (MM) who received prior treatment with Revlimid lenalidomide showing that Pomalyst pomalidomide plus Velcade...
17:44 , Jul 11, 2018 |  BC Extra  |  Company News

Shanghai Junshi licenses anti-PD-1 mAb to CSPC

Shanghai Junshi Biosciences Co. Ltd. (Shanghai, China) granted CSPC Pharmaceutical Group Ltd. (HKSE:1093) exclusive rights in China, including Hong Kong and Macau, and Taiwan to develop and commercialize an undisclosed anti-PD-1 mAb in combination with...
22:55 , May 11, 2018 |  BioCentury  |  Strategy

Takeda hits the gas

Takeda Pharmaceutical Co. Ltd.’s proposed acquisition of Shire plc is an acceleration of -- not a departure from -- CEO Christophe Weber’s stated strategy to build a top-tier global pharma, according to management. On May 8,...
17:57 , May 4, 2018 |  BioCentury  |  Politics, Policy & Law

A Remembrance: An exceptional responder

Jane Reese-Coulbourne was an exceptional responder. In 1990, faced with a diagnosis of advanced breast cancer, she enrolled in a clinical trial at the National Cancer Institute, enduring a grueling regimen of high doses of...
15:34 , May 4, 2018 |  BC Week In Review  |  Clinical News

Karyopharm planning selinexor submissions in MM

Karyopharm Therapeutics Inc. (NASDAQ:KPTI) reported that selinexor (KPT-330) met the primary endpoint of improving overall response rate (ORR) in the Phase IIb STORM trial to treat penta-refractory multiple myeloma. Based on the data, the company...