19:19 , Aug 10, 2018 |  BC Week In Review  |  Clinical News

FDA approves Kyowa's Poteligeo for CTCL

FDA approved Poteligeo mogamulizumab-kpkc from Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) to treat the two most common forms of cutaneous T cell lymphoma (CTCL). The agency approved Poteligeo to treat adults with relapsed or refractory mycosis...
18:31 , Aug 8, 2018 |  BC Extra  |  Company News

FDA approves Kyowa's Poteligeo for CTCL

FDA approved Poteligeo mogamulizumab-kpkc from Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) to treat the two most common forms of cutaneous T cell lymphoma. The agency approved Poteligeo to treat adults with relapsed or refractory mycosis fungoides...
22:10 , Aug 7, 2018 |  BC Extra  |  Preclinical News

Blood-based assay could predict Tecentriq's benefit in NSCLC

A blood-based tumor mutation burden (bTMB) assay could predict anti-PD-L1 mAb Tecentriq atezolizumab's clinical benefit in non-small cell lung cancer patients. The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY), Foundation Medicine Inc. (NASDAQ:FMI) and academic...
00:46 , Aug 4, 2018 |  BioCentury  |  Finance

Functions of formulation

Halozyme Therapeutics Inc. is quickly expanding the reach of its Enhanze platform on the back of regulatory approvals for products that are now gaining market share, plus a playbook for streamlined early development it can...
17:04 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

Otsuka's guadecitabine misses in Phase III for first-line AML

Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) and its Astex Pharmaceuticals Inc. subsidiary said first-line treatment with guadecitabine (formerly SGI-110) missed the co-primary endpoints in the Phase III ASTRAL-1 trial to treat previously untreated acute myelogenous...
17:21 , Jul 27, 2018 |  BC Week In Review  |  Clinical News

Takeda's Alunbrig meets in Phase III for first-line NSCLC

Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said first-line treatment with Alunbrig brigatinib met the primary endpoint of improving independent review committee (IRC)-assessed progression-free survival (PFS) vs. Xalkori crizotinib in the Phase III ALTA-1L trial to treat...
16:37 , Jul 27, 2018 |  BC Week In Review  |  Clinical News

Keytruda monotherapy meets in Phase III for first-line SCCHN

Merck & Co Inc. (NYSE:MRK) said first-line treatment with Keytruda pembrolizumab as monotherapy met the primary endpoint of improving overall survival (OS) in PD-L1-positive patients vs. standard of care (SOC) in the Phase III KEYNOTE-048...
16:36 , Jul 27, 2018 |  BC Week In Review  |  Clinical News

Celgene planning regulatory submissions for Revlimid in indolent lymphoma on Phase III win

Celgene Corp. (NASDAQ:CELG) said Revlimid lenalidomide plus Rituxan rituximab met the primary endpoint of improving progression-free survival (PFS) vs. placebo plus Rituxan in the Phase III AUGMENT trial to treat relapsed or refractory follicular and...
16:34 , Jul 27, 2018 |  BC Week In Review  |  Clinical News

Tecentriq combo again meets PFS endpoint in Phase III for first-line NSCLC

The Genentech Inc. unit of Roche (SIX:ROG; OTCQB:RHHBY) said first-line treatment with Tecentriq atezolizumab plus chemotherapy met the co-primary endpoint of improving progression-free survival (PFS) vs. chemotherapy alone in the Phase III IMpower132 trial to...
15:38 , Jul 27, 2018 |  BC Week In Review  |  Clinical News

New data, designation bolster BeiGene's planned submissions

BeiGene Ltd. (NASDAQ:BGNE) reported response rate data from a pivotal, Chinese Phase II trial of PD-1 inhibitor tislelizumab (BGB-A317) to treat classical Hodgkin's lymphoma (cHL), for which the company is planning a regulatory submission this...