17:06 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

CHMP positive on patisiran, Symkevi, Humira and Neulasta biosimilars

EMA's CHMP recommended a number of approvals July 26, including Onpattro patisiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY), Symkevi tezacaftor/ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), a handful of cancer therapies and three biosimilars. The committee recommended approval...
22:08 , Jul 27, 2018 |  BC Extra  |  Company News

CHMP positive on patisiran, Symkevi, Humira and Neulasta biosimilars

EMA's CHMP recommended a number of approvals Friday, including Onpattro patisiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY), Symkevi tezacaftor/ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), a handful of cancer therapies and three biosimilars. The committee recommended approval of...
15:54 , Jul 25, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Melanoma Cell culture and mouse studies suggest inhibiting RXR could help treat melanoma. In a human melanoma cell line, the combination of a tool compound RXR inhibitor and Mekinist trametinib decreased colony formation and viability...
23:28 , Jul 13, 2018 |  BC Extra  |  Preclinical News

RXR a potential minimal residual disease target in melanoma

New research into the biology of solid tumor minimal residual disease (MRD) has revealed retinoid X receptor (RXR) as a potential target to delay development of drug resistance in melanoma. Cancer relapse is driven by MRD,...
19:14 , Jul 13, 2018 |  BC Week In Review  |  Clinical News

Array reports Phase III OS data for encorafenib/binimetinib/Erbitux triple combo in mCRC

Array BioPharma Inc. (NASDAQ:ARRY) reported additional data from the safety lead-in portion of the open-label, international Phase III BEACON CRC trial showing that encorafenib (LGX818) plus binimetinib (MEK162) and Erbitux cetuximab led to a one-year...
21:43 , Jul 12, 2018 |  BC Innovations  |  Translation in Brief

New Therapeutic Targets and Biomarkers: June 2018

New Therapeutic Targets and Biomarkers: June 2018 Select top therapeutic targets and biomarkers covered by BioCentury or added to the BCIQ database during June 2018. Therapeutic targets are defined as any protein, gene or other molecule...
21:35 , Jul 10, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Melanoma, colorectal cancer In vitro, cell culture and mouse studies identified an aminopyrimidine-based dual MAPK1/MAPK3 inhibitor that could help treat BRAF-mutant melanoma and colorectal cancer. Fragment-based screening, chemical synthesis and in vitro enzyme activity...
03:05 , Jun 30, 2018 |  BioCentury  |  Finance

Hidden in the rough

Judicious stock picking was especially important in the second quarter, as 57% of global biotech stocks saw their equity values decline. Volatility continued to roil global markets during the period and additional uncertainty looms with the...
02:23 , Jun 30, 2018 |  BioCentury  |  Product Development

Defining access potential - before it’s too late

We see it everywhere: confirmation bias. Innovators believe in a drug, find the evidence to support its value, and dismiss or ignore the facts challenging their preferred story. But confirmation bias is particularly problematic thanks...
18:12 , Jun 29, 2018 |  BC Week In Review  |  Clinical News

FDA approves Array's drug combo to treat melanoma

Array BioPharma Inc. (NASDAQ:ARRY) said FDA approved Braftovi encorafenib in combination with Mektovi binimetinib to treat BRAF V600 mutation-positive unresectable or metastatic melanoma. The company said the combo is now available, but declined to provide...