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...
21:26 , Jul 27, 2018 |  BioCentury  |  Regulation

Biosimilar barriers

A coming showdown over anticompetitive contracting practices, coupled with an impending wave of patent expirations, could result in a wave of biosimilar approvals and launches in the U.S. over the next year, according to biosimilars...
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...
17:50 , Jun 29, 2018 |  BioCentury  |  Regulation

Biosimilars do-over

As part of an initiative to stimulate biosimilar competition, FDA is planning a do-over of draft guidance on statistical methods for demonstrating biosimilarity to a reference product. The agency announced on June 21 it was...
18:29 , Jun 8, 2018 |  BC Week In Review  |  Clinical News

CHMP recommendations include Aimovig, orphan candidates

Among a host of positive recommendations announced on June 1, EMA's CHMP backed approval of migraine therapy Aimovig erenumab and Orphan Drug designees Tegsedi inotersen for hereditary transthyretin (TTR) amyloidosis and Myalepta metreleptin for leptin...
18:29 , Jun 8, 2018 |  BC Week In Review  |  Clinical News

FDA approves Lilly's Olumiant for RA

FDA approved Olumiant baricitinib from Eli Lilly and Co. (NYSE:LLY) and partner Incyte Corp. (NASDAQ:INCY) to treat moderate to severe rheumatoid arthritis in patients who have responded poorly to one or more TNF antagonists. Lilly intends...
17:02 , Jun 1, 2018 |  BC Extra  |  Company News

FDA approves Lilly's Olumiant for RA

FDA approved Olumiant baricitinib from Eli Lilly and Co. (NYSE:LLY) and partner Incyte Corp. (NASDAQ:INCY) to treat moderate to severe rheumatoid arthritis in patients who have responded poorly to one or more TNF antagonists. Lilly intends...
14:44 , Jun 1, 2018 |  BC Extra  |  Company News

CHMP's recommendations include Aimovig, Orphan candidates

Among a host of positive recommendations announced Friday, EMA's CHMP backed approval of migraine therapy Aimovig erenumab and Orphan Drug designees Tegsedi inotersen for hereditary transthyretin (TTR) amyloidosis and Myalepta metreleptin for leptin deficiency. The committee...
19:55 , Apr 27, 2018 |  BC Week In Review  |  Financial News

Innovent raises $150M series E

Innovent Biologics Inc. (Suzhou, China) raised $150 million in a series E round. Lead investor Capital Group Private Markets committed $90 million in the round, and its partner Nick Chen joined Innovent’s board. New investors Cormorant...