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...
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...
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...
23:09 , Apr 6, 2018 |  BioCentury  |  Finance

Fundamentally driven

Continued struggles by the mega-cap bellwethers and the resurgence of volatility in global equity markets were the major themes of 1Q18, whipsawing biotech stocks throughout the quarter but leaving index values little changed on the...
18:29 , Mar 23, 2018 |  BC Week In Review  |  Clinical News

Sun's IL-23 psoriasis mab approved by FDA

Sun Pharmaceutical Industries Ltd. (BSE:524715; NSE:SUNPHARMA) said FDA approved Ilumya tildrakizumab-asmn (MK-3222) to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Ilumya is a humanized mAb against IL-23 subunit...
18:41 , Mar 21, 2018 |  BC Extra  |  Company News

Sun's IL-23 mAb gets FDA approval for psoriasis

Sun Pharmaceutical Industries Ltd. (BSE:524715; NSE:SUNPHARMA) said FDA approved Ilumya tildrakizumab-asmn (MK-3222) to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Ilumya is a humanized mAb against IL-23 subunit...
18:14 , Feb 28, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Chronic lymphocytic leukemia (CLL) Patient sample, cell culture and mouse studies suggest inhibiting IL23P19-IL-23 receptor signaling could help treat CLL. In peripheral blood mononuclear cells (PBMCs) from patients, high levels of IL-23 receptor were...
00:20 , Dec 22, 2017 |  BC Innovations  |  Product R&D

Dengvaxia’s warning

The fallout of Sanofi’s dengue vaccine debacle has researchers scrambling to rationalize whether competitor products will fall afoul of the same effects, and whether other, related fields should change course. The early upshot is that...
19:21 , Sep 19, 2017 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Brain cancer...
23:42 , Sep 14, 2017 |  BC Extra  |  Company News

Management tracks: SymCel, Taro, Akcea

SymCel Sverige AB (Spanga, Sweden) named Jesper Ericsson CEO. He was director of marketing and sales at BioLamina AB (Stockholm, Sweden). SymCel offers a cell-based assay for real-time monitoring of cell metabolism. Prescription and OTC...